Steven R. Alexander, MD
Safety Efficacy of Iron Sucrose in Children
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Randomized, controlled, open label trial of pediatric CKD patients on stable EPO therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)
Recruiting Status:
No longer recruitingStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: iron sucrose injection
- Drug: Venofer (Iron sucrose)
Phase:
Phase 4Eligibility
Ages Eligible for Study:
2 years to 21 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:
Male or female PDD or HDD or NDD-CKD patients 32 to L 21 years.
Dialysis patients must be on a stable PD or HD regimen for 3 months.
NDD patients must have GFR <60 mLlminl1.73 m2 for 23 months (via the Schwartz equation for subjects 5 18 years and MDRD for subjects > 18 years).
Hgb from most recent local lab 2 11.0 to 5 13.5 g1dL.
Screening Hgb (central lab) 2 1 1 .O to 5 13.5 g/dL.
Screening Ferritin (central lab) I 800 ng/ml.
Screening TSAT (central lab) 2 20% to I 50%.
Have received stable erythropoietin therapy at 25% of current dose) for 8 weeks prior to the qualifying screening visit
No erythropoietin dosing or product changes are anticipated for the length of trial.
Females at risk of pregnancy must be practicing an acceptable form of birth control and have a negative serum pregnancy test.
No investigational drugs for 30 days prior to randomization.
Key Exclusion Criteria:
Exclusion Criteria:
Known history of hypersensitivity or significant intolerance to venofer.
Patients with significant severe diseases of the liver, hemopoietic system, cardiovascular system, psychiatric disorder or other conditions which, in the opinion of the investigator, may place a subject at added risk.
Serious infection requiring hospitalization within 4 weeks of the Screen 1 visit.
Significant blood loss (greater than 100mL) within the last 3 months.
Bleeding disorders.
Pregnancy or lactation.
Actively being treated for asthma.
Hemoglobinopathy.
Receiving a myelosuppressive drug.
Anticipated major surgery requiring hospitalization during the study other than for vascular access or peritoneal catheter revisions.
Additional Study Details
Official Title:
Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric CKD PatientsAnticipated start date:
7/20/2005Lead Sponsor:
Luitpold PharmaceuticalsInvestigator(s):
Study Type:
InterventionalPurpose:
DiagnosticAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
SafetyPrimary Outcomes:
- Safety - incidence of adverse advents
Secondary Outcomes:
- Clinical success
Total Number to be Enrolled:
120Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- 2015
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.
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