Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy
This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine.
Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- dietary supplement: Omega-3 Fatty Acid Fish Oil Supplement
- drug: Intravenous Rituximab
- drug: ACE/ARB
Eligibility
Inclusion Criteria:
- Any patient between the age of 18 and 70 years of age and able to give informed
consent
- GFR by Cockcroft-Gault or MDRD equations <90 mls/min and >30 mls/min
- Greater than or equal to 1000 mg of proteinuria/24 hours while on stable ACEi, ARB or
renin inhibitor therapy for 2 months. Patients receiving combination ACE or ARB or
ACEi and a renin inhibitor for 2 months will only require 500mg/24 hours
- Blood pressure <130/80 mmHg. The presence of hypertension is not required for study
entry, but any patient requiring long term hypertensive medications must have blood
pressure controlled <130-80 mmHg, to be considered eligible for the study
- Female patients with IgA will be considered eligible for study entry if they have a
negative urine or serum pregnancy test at the time of screening are agreeable to 2
years of contraception
- Biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein
Purpura will be considered eligible for the study
- Able to swallow the oral medications
Exclusion Criteria
- Clinical and histologic evidence of IgA predominant Lupus nephritis
- Clinical and histologic evidence of idiopathic IgA forms of membranoproliferative
glomerulonephritis
- Clinical evidence of cirrhosis, chronic active liver disease or known infection with
hepatitis B, C or HIV
- Estimated GFR <30 ml/min/1.73m² at the time of screening
- Greater than 50% glomerular senescence or cortical scarring on renal biopsy
- Active systemic infection or history of serious infection within one month of entry
- History of Crohn's disease or Celiac Sprue
- Positive pregnancy test or breast feeding at time of study entry or unwilling to
comply with contraceptive measures
- Current or recent (within 30 days) exposure to any investigational drug
- Serum Cr >3.5 mg/dl or Modification of Diet in Renal Disease (MDRD) calculated GFR <30
mls/min
- Patients receiving >6 months therapy with oral prednisone or glucocorticoid equivalent
- Live vaccine within 28 days of study enrollment.
General Safety & Laboratory Exclusion Criteria
- Patients with anaphylaxis and/or known allergic reactions to Rituximab
- Hemoglobin: <8.5 gm/dL
- Platelets: <100,000/mm
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x Upper Limit
of Normal unless related to primary disease.
- Previous Treatment with Rituximab(MabThera®/Rituxan®)
- Previous treatment with Natalizumab(Tysabri®)
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies
- History of recurrent significant infection or recurrent bacterial infections
- Known active bacterial, viral fungal mycobacterial or atypical mycobacterial
infections, but excluding fungal infections of nail beds
- Any major episode of infection requiring hospitalization or treatment with i.v.
antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to
screening
- Ongoing use of high dose steroids(>10 mg/day)or unstable steroid dose in the past 4
weeks
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 6 months prior to screening
- Pregnancy (a negative serum or urine pregnancy test will be performed for all women of
childbearing potential no later than 7 days prior to treatment) or lactation
- Concomitant or previous malignancies, with the exception of adequately treated basal
or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- History of psychiatric disorder that would interfere with normal participation in this
protocol
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complication
- Inability to comply with study and follow-up procedures
Ages Eligible for Study
18 Years - 70 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Richard Lafayette, MD
650-736-1822
I'm interested
Psoriasis Clinical Trials
Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy
This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine.
Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- dietary supplement: Omega-3 Fatty Acid Fish Oil Supplement
- drug: Intravenous Rituximab
- drug: ACE/ARB
Eligibility
Inclusion Criteria:
- Any patient between the age of 18 and 70 years of age and able to give informed
consent
- GFR by Cockcroft-Gault or MDRD equations <90 mls/min and >30 mls/min
- Greater than or equal to 1000 mg of proteinuria/24 hours while on stable ACEi, ARB or
renin inhibitor therapy for 2 months. Patients receiving combination ACE or ARB or
ACEi and a renin inhibitor for 2 months will only require 500mg/24 hours
- Blood pressure <130/80 mmHg. The presence of hypertension is not required for study
entry, but any patient requiring long term hypertensive medications must have blood
pressure controlled <130-80 mmHg, to be considered eligible for the study
- Female patients with IgA will be considered eligible for study entry if they have a
negative urine or serum pregnancy test at the time of screening are agreeable to 2
years of contraception
- Biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein
Purpura will be considered eligible for the study
- Able to swallow the oral medications
Exclusion Criteria
- Clinical and histologic evidence of IgA predominant Lupus nephritis
- Clinical and histologic evidence of idiopathic IgA forms of membranoproliferative
glomerulonephritis
- Clinical evidence of cirrhosis, chronic active liver disease or known infection with
hepatitis B, C or HIV
- Estimated GFR <30 ml/min/1.73m² at the time of screening
- Greater than 50% glomerular senescence or cortical scarring on renal biopsy
- Active systemic infection or history of serious infection within one month of entry
- History of Crohn's disease or Celiac Sprue
- Positive pregnancy test or breast feeding at time of study entry or unwilling to
comply with contraceptive measures
- Current or recent (within 30 days) exposure to any investigational drug
- Serum Cr >3.5 mg/dl or Modification of Diet in Renal Disease (MDRD) calculated GFR <30
mls/min
- Patients receiving >6 months therapy with oral prednisone or glucocorticoid equivalent
- Live vaccine within 28 days of study enrollment.
General Safety & Laboratory Exclusion Criteria
- Patients with anaphylaxis and/or known allergic reactions to Rituximab
- Hemoglobin: <8.5 gm/dL
- Platelets: <100,000/mm
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x Upper Limit
of Normal unless related to primary disease.
- Previous Treatment with Rituximab(MabThera®/Rituxan®)
- Previous treatment with Natalizumab(Tysabri®)
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies
- History of recurrent significant infection or recurrent bacterial infections
- Known active bacterial, viral fungal mycobacterial or atypical mycobacterial
infections, but excluding fungal infections of nail beds
- Any major episode of infection requiring hospitalization or treatment with i.v.
antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to
screening
- Ongoing use of high dose steroids(>10 mg/day)or unstable steroid dose in the past 4
weeks
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 6 months prior to screening
- Pregnancy (a negative serum or urine pregnancy test will be performed for all women of
childbearing potential no later than 7 days prior to treatment) or lactation
- Concomitant or previous malignancies, with the exception of adequately treated basal
or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- History of psychiatric disorder that would interfere with normal participation in this
protocol
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complication
- Inability to comply with study and follow-up procedures
Ages Eligible for Study
18 Years - 70 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Richard Lafayette, MD
650-736-1822
I'm interested
Dermatology Clinical Trials
Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy
This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine.
Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- dietary supplement: Omega-3 Fatty Acid Fish Oil Supplement
- drug: Intravenous Rituximab
- drug: ACE/ARB
Eligibility
Inclusion Criteria:
- Any patient between the age of 18 and 70 years of age and able to give informed
consent
- GFR by Cockcroft-Gault or MDRD equations <90 mls/min and >30 mls/min
- Greater than or equal to 1000 mg of proteinuria/24 hours while on stable ACEi, ARB or
renin inhibitor therapy for 2 months. Patients receiving combination ACE or ARB or
ACEi and a renin inhibitor for 2 months will only require 500mg/24 hours
- Blood pressure <130/80 mmHg. The presence of hypertension is not required for study
entry, but any patient requiring long term hypertensive medications must have blood
pressure controlled <130-80 mmHg, to be considered eligible for the study
- Female patients with IgA will be considered eligible for study entry if they have a
negative urine or serum pregnancy test at the time of screening are agreeable to 2
years of contraception
- Biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein
Purpura will be considered eligible for the study
- Able to swallow the oral medications
Exclusion Criteria
- Clinical and histologic evidence of IgA predominant Lupus nephritis
- Clinical and histologic evidence of idiopathic IgA forms of membranoproliferative
glomerulonephritis
- Clinical evidence of cirrhosis, chronic active liver disease or known infection with
hepatitis B, C or HIV
- Estimated GFR <30 ml/min/1.73m² at the time of screening
- Greater than 50% glomerular senescence or cortical scarring on renal biopsy
- Active systemic infection or history of serious infection within one month of entry
- History of Crohn's disease or Celiac Sprue
- Positive pregnancy test or breast feeding at time of study entry or unwilling to
comply with contraceptive measures
- Current or recent (within 30 days) exposure to any investigational drug
- Serum Cr >3.5 mg/dl or Modification of Diet in Renal Disease (MDRD) calculated GFR <30
mls/min
- Patients receiving >6 months therapy with oral prednisone or glucocorticoid equivalent
- Live vaccine within 28 days of study enrollment.
General Safety & Laboratory Exclusion Criteria
- Patients with anaphylaxis and/or known allergic reactions to Rituximab
- Hemoglobin: <8.5 gm/dL
- Platelets: <100,000/mm
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x Upper Limit
of Normal unless related to primary disease.
- Previous Treatment with Rituximab(MabThera®/Rituxan®)
- Previous treatment with Natalizumab(Tysabri®)
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies
- History of recurrent significant infection or recurrent bacterial infections
- Known active bacterial, viral fungal mycobacterial or atypical mycobacterial
infections, but excluding fungal infections of nail beds
- Any major episode of infection requiring hospitalization or treatment with i.v.
antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to
screening
- Ongoing use of high dose steroids(>10 mg/day)or unstable steroid dose in the past 4
weeks
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 6 months prior to screening
- Pregnancy (a negative serum or urine pregnancy test will be performed for all women of
childbearing potential no later than 7 days prior to treatment) or lactation
- Concomitant or previous malignancies, with the exception of adequately treated basal
or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- History of psychiatric disorder that would interfere with normal participation in this
protocol
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complication
- Inability to comply with study and follow-up procedures
Ages Eligible for Study
18 Years - 70 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Richard Lafayette, MD
650-736-1822
I'm interested
Pediatric Dermatology Clinical Trials
Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy
This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine.
Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- dietary supplement: Omega-3 Fatty Acid Fish Oil Supplement
- drug: Intravenous Rituximab
- drug: ACE/ARB
Eligibility
Inclusion Criteria:
- Any patient between the age of 18 and 70 years of age and able to give informed
consent
- GFR by Cockcroft-Gault or MDRD equations <90 mls/min and >30 mls/min
- Greater than or equal to 1000 mg of proteinuria/24 hours while on stable ACEi, ARB or
renin inhibitor therapy for 2 months. Patients receiving combination ACE or ARB or
ACEi and a renin inhibitor for 2 months will only require 500mg/24 hours
- Blood pressure <130/80 mmHg. The presence of hypertension is not required for study
entry, but any patient requiring long term hypertensive medications must have blood
pressure controlled <130-80 mmHg, to be considered eligible for the study
- Female patients with IgA will be considered eligible for study entry if they have a
negative urine or serum pregnancy test at the time of screening are agreeable to 2
years of contraception
- Biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein
Purpura will be considered eligible for the study
- Able to swallow the oral medications
Exclusion Criteria
- Clinical and histologic evidence of IgA predominant Lupus nephritis
- Clinical and histologic evidence of idiopathic IgA forms of membranoproliferative
glomerulonephritis
- Clinical evidence of cirrhosis, chronic active liver disease or known infection with
hepatitis B, C or HIV
- Estimated GFR <30 ml/min/1.73m² at the time of screening
- Greater than 50% glomerular senescence or cortical scarring on renal biopsy
- Active systemic infection or history of serious infection within one month of entry
- History of Crohn's disease or Celiac Sprue
- Positive pregnancy test or breast feeding at time of study entry or unwilling to
comply with contraceptive measures
- Current or recent (within 30 days) exposure to any investigational drug
- Serum Cr >3.5 mg/dl or Modification of Diet in Renal Disease (MDRD) calculated GFR <30
mls/min
- Patients receiving >6 months therapy with oral prednisone or glucocorticoid equivalent
- Live vaccine within 28 days of study enrollment.
General Safety & Laboratory Exclusion Criteria
- Patients with anaphylaxis and/or known allergic reactions to Rituximab
- Hemoglobin: <8.5 gm/dL
- Platelets: <100,000/mm
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x Upper Limit
of Normal unless related to primary disease.
- Previous Treatment with Rituximab(MabThera®/Rituxan®)
- Previous treatment with Natalizumab(Tysabri®)
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies
- History of recurrent significant infection or recurrent bacterial infections
- Known active bacterial, viral fungal mycobacterial or atypical mycobacterial
infections, but excluding fungal infections of nail beds
- Any major episode of infection requiring hospitalization or treatment with i.v.
antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to
screening
- Ongoing use of high dose steroids(>10 mg/day)or unstable steroid dose in the past 4
weeks
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 6 months prior to screening
- Pregnancy (a negative serum or urine pregnancy test will be performed for all women of
childbearing potential no later than 7 days prior to treatment) or lactation
- Concomitant or previous malignancies, with the exception of adequately treated basal
or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- History of psychiatric disorder that would interfere with normal participation in this
protocol
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complication
- Inability to comply with study and follow-up procedures
Ages Eligible for Study
18 Years - 70 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Richard Lafayette, MD
650-736-1822
I'm interested
Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy
This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine.
Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- dietary supplement: Omega-3 Fatty Acid Fish Oil Supplement
- drug: Intravenous Rituximab
- drug: ACE/ARB
Eligibility
Inclusion Criteria:
- Any patient between the age of 18 and 70 years of age and able to give informed
consent
- GFR by Cockcroft-Gault or MDRD equations <90 mls/min and >30 mls/min
- Greater than or equal to 1000 mg of proteinuria/24 hours while on stable ACEi, ARB or
renin inhibitor therapy for 2 months. Patients receiving combination ACE or ARB or
ACEi and a renin inhibitor for 2 months will only require 500mg/24 hours
- Blood pressure <130/80 mmHg. The presence of hypertension is not required for study
entry, but any patient requiring long term hypertensive medications must have blood
pressure controlled <130-80 mmHg, to be considered eligible for the study
- Female patients with IgA will be considered eligible for study entry if they have a
negative urine or serum pregnancy test at the time of screening are agreeable to 2
years of contraception
- Biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein
Purpura will be considered eligible for the study
- Able to swallow the oral medications
Exclusion Criteria
- Clinical and histologic evidence of IgA predominant Lupus nephritis
- Clinical and histologic evidence of idiopathic IgA forms of membranoproliferative
glomerulonephritis
- Clinical evidence of cirrhosis, chronic active liver disease or known infection with
hepatitis B, C or HIV
- Estimated GFR <30 ml/min/1.73m² at the time of screening
- Greater than 50% glomerular senescence or cortical scarring on renal biopsy
- Active systemic infection or history of serious infection within one month of entry
- History of Crohn's disease or Celiac Sprue
- Positive pregnancy test or breast feeding at time of study entry or unwilling to
comply with contraceptive measures
- Current or recent (within 30 days) exposure to any investigational drug
- Serum Cr >3.5 mg/dl or Modification of Diet in Renal Disease (MDRD) calculated GFR <30
mls/min
- Patients receiving >6 months therapy with oral prednisone or glucocorticoid equivalent
- Live vaccine within 28 days of study enrollment.
General Safety & Laboratory Exclusion Criteria
- Patients with anaphylaxis and/or known allergic reactions to Rituximab
- Hemoglobin: <8.5 gm/dL
- Platelets: <100,000/mm
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x Upper Limit
of Normal unless related to primary disease.
- Previous Treatment with Rituximab(MabThera®/Rituxan®)
- Previous treatment with Natalizumab(Tysabri®)
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies
- History of recurrent significant infection or recurrent bacterial infections
- Known active bacterial, viral fungal mycobacterial or atypical mycobacterial
infections, but excluding fungal infections of nail beds
- Any major episode of infection requiring hospitalization or treatment with i.v.
antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to
screening
- Ongoing use of high dose steroids(>10 mg/day)or unstable steroid dose in the past 4
weeks
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 6 months prior to screening
- Pregnancy (a negative serum or urine pregnancy test will be performed for all women of
childbearing potential no later than 7 days prior to treatment) or lactation
- Concomitant or previous malignancies, with the exception of adequately treated basal
or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- History of psychiatric disorder that would interfere with normal participation in this
protocol
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complication
- Inability to comply with study and follow-up procedures
Ages Eligible for Study
18 Years - 70 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Richard Lafayette, MD
650-736-1822
I'm interested
Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy
This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine.
Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- dietary supplement: Omega-3 Fatty Acid Fish Oil Supplement
- drug: Intravenous Rituximab
- drug: ACE/ARB
Eligibility
Inclusion Criteria:
- Any patient between the age of 18 and 70 years of age and able to give informed
consent
- GFR by Cockcroft-Gault or MDRD equations <90 mls/min and >30 mls/min
- Greater than or equal to 1000 mg of proteinuria/24 hours while on stable ACEi, ARB or
renin inhibitor therapy for 2 months. Patients receiving combination ACE or ARB or
ACEi and a renin inhibitor for 2 months will only require 500mg/24 hours
- Blood pressure <130/80 mmHg. The presence of hypertension is not required for study
entry, but any patient requiring long term hypertensive medications must have blood
pressure controlled <130-80 mmHg, to be considered eligible for the study
- Female patients with IgA will be considered eligible for study entry if they have a
negative urine or serum pregnancy test at the time of screening are agreeable to 2
years of contraception
- Biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein
Purpura will be considered eligible for the study
- Able to swallow the oral medications
Exclusion Criteria
- Clinical and histologic evidence of IgA predominant Lupus nephritis
- Clinical and histologic evidence of idiopathic IgA forms of membranoproliferative
glomerulonephritis
- Clinical evidence of cirrhosis, chronic active liver disease or known infection with
hepatitis B, C or HIV
- Estimated GFR <30 ml/min/1.73m² at the time of screening
- Greater than 50% glomerular senescence or cortical scarring on renal biopsy
- Active systemic infection or history of serious infection within one month of entry
- History of Crohn's disease or Celiac Sprue
- Positive pregnancy test or breast feeding at time of study entry or unwilling to
comply with contraceptive measures
- Current or recent (within 30 days) exposure to any investigational drug
- Serum Cr >3.5 mg/dl or Modification of Diet in Renal Disease (MDRD) calculated GFR <30
mls/min
- Patients receiving >6 months therapy with oral prednisone or glucocorticoid equivalent
- Live vaccine within 28 days of study enrollment.
General Safety & Laboratory Exclusion Criteria
- Patients with anaphylaxis and/or known allergic reactions to Rituximab
- Hemoglobin: <8.5 gm/dL
- Platelets: <100,000/mm
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x Upper Limit
of Normal unless related to primary disease.
- Previous Treatment with Rituximab(MabThera®/Rituxan®)
- Previous treatment with Natalizumab(Tysabri®)
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies
- History of recurrent significant infection or recurrent bacterial infections
- Known active bacterial, viral fungal mycobacterial or atypical mycobacterial
infections, but excluding fungal infections of nail beds
- Any major episode of infection requiring hospitalization or treatment with i.v.
antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to
screening
- Ongoing use of high dose steroids(>10 mg/day)or unstable steroid dose in the past 4
weeks
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 6 months prior to screening
- Pregnancy (a negative serum or urine pregnancy test will be performed for all women of
childbearing potential no later than 7 days prior to treatment) or lactation
- Concomitant or previous malignancies, with the exception of adequately treated basal
or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- History of psychiatric disorder that would interfere with normal participation in this
protocol
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complication
- Inability to comply with study and follow-up procedures
Ages Eligible for Study
18 Years - 70 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Richard Lafayette, MD
650-736-1822
I'm interested