Status:
COMPLETED
Pharmacokinetic of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief Summary
This is an open-label, multicenter pharmacokinetic study of Hemodialysis (HD) or Peritoneal Dialysis (PD) patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted ...
Detailed Description
This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin. Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undil...
Eligibility Criteria
Inclusion
- Age between 12 and 18 years
- History of Chronic Renal Failure requiring HD or PD
- Hgb \</= 13 g/dL
- Ferritin \< 800 ng/ml
- Transferrin Saturation (TSAT) \< 50%
- Receiving epoetin
Exclusion
- Known Sensitivity to Iron Sucrose
- Severe Concomitant disease of the liver or cardiovascular system
- Serious bacterial Infection
- Pregnancy / Lactation
- Active Hepatitis
- Patients with Causes of iron deficiency other that Chronic Renal Failure
- Blood Transfusion
- Body Weight \< 25 kilograms
- Currently being treated for Asthma
- Received investigational drug within last 30 days
Key Trial Info
Start Date :
June 5 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2003
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00239616
Start Date
June 5 2002
End Date
September 15 2003
Last Update
May 18 2025
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