Minnie Sarwal
Efficacy study of Sriolimus, in place of Prograf, post-transplant to decrease kidney scarring and improveme kidney function and survival of the kidney.
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this experimental study is to determine whether children can safely be withdrawn from Prograf? after transplantation and changed to Rapamycin? (sirolimus). Recent research studies in adult transplantation have demonstrated that with the use of Rapamycin? (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase in rejection, with decreased scarring in the kidney, and with improvements in kidney function and survival of the kidney.
Recruiting Status:
Not yet recruitingStanford Recruiting Status:
Not yet recruitingCondition(s):
Intervention(s):
- Drug: Sirolimus
Phase:
Phase 4Eligibility
Ages Eligible for Study:
1 years to 18 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Inclusion Criteria at transplantation:
1. Age < 19 years (up to the day of the 19th birthday)
2. Panel Reactive Antibody Level (PRA) <20% (Flow cytometry method)
3. Recipient of first living donor or deceased donor renal transplantation
4. Signed and dated informed consent (per local IRB standards)
Inclusion Criteria at 6 months post-transplantation:
1. Patients with 1 or fewer episodes of acute rejection
2. Urine Pro/Cr less than 0.5
3. Stable allograft function for at least 30 days prior to enrollment
4. GFR (Schwartz formula) > 40 ml/min/1.73 m2
5. Female patients of childbearing potential must have a negative pregnancy test before SRL administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of SRL. Any woman becoming pregnant during the treatment period must discontinue SRL treatment
6. Total white blood cell count >4000/mm3, platelet count >100,000/mm3, fasting triglycerides <500 mg/dL, fasting cholesterol <350 mg/dL
Key Exclusion Criteria:
Exclusion Criteria at transplantation:
1. Recipients of multi-organ transplants (e.g. kidney/pancreas transplant, etc.)
2. Peak PRA > 20% at any time
3. Recipient of en-bloc kidneys
4. Recipient of an organ from an HLA identical donor or a non-heart beating donor
5. Pregnant or lactating
6. Positive for HIV or an immunodeficiency virus
7. History of malignancy
8. Use of investigational agents within 4 weeks prior to transplantation
9. Current use of terfenadine, cisapride, astemizole, or pimozide (unless discontinued before administration of SRL)
10. Known hypersensitivity to sirolimus
11. Known hypersensitivity to Prograf, Cellcept, prednisone, Cremophor, HCO-60, or murine products
Exclusion Criteria at 6 months post-transplantation:
1. Rejection episode less than 30 days prior to time of conversion
2. Failure to obtain a renal biopsy at the time of conversion
3. Evidence of active infection
4. History of malignancy
5. Use of immunosuppressive agents other than Tacrolimus, Mycophenolate mofetil, or corticosteroids
6. Current use of terfenadine, cisapride, astemizole, or pimozide (unless discontinued before administration of SRL)
7. Evidence of infiltrate, cavitation, or consolidation on chest x-ray during prestudy screening
Additional Study Details
Official Title:
Novel Pilot Trial of Sirolimus, Mycophenolate Mofetil, and Corticosteroids versus a Historic Control Population Receiving Calcineurin Inhibitors Based ImmunosupressionAnticipated start date:
9/30/2008Lead Sponsor:
WyethCollaborator(s):
- University of Alabama
Investigator(s):
Study Type:
InterventionalPurpose:
PreventionAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Primary outcome will be allograft function as determined by Cystatin C and Shwartz formula calculation
Secondary Outcomes:
- Secondary outcomes will include biopsy proven acute rejection episodes, progression of quantitative interstitial fibrosis as determined by Sirius Red staining and digital image analysis, Allograft survival and patient survival at 12 and 24 months post transplant.
Total Number to be Enrolled:
50Total Number to be Enrolled at Stanford:
13More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
2/17/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help