Pharmacokinetic of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
- Registration Number
- NCT00239616
- Lead Sponsor
- American Regent, Inc.
- 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 by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.
- 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, undiluted by slow IV push over 5 minutes, and underwent serial blood draws. The patients were subsequently followed for 7 days for safety endpoints.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Iron Sucrose Iron Sucrose injection A single 100 mg dose (1 vial), 20 mg/min injected over 5 minutes
- Primary Outcome Measures
Name Time Method Maximum Measured Plasma Concentration (Cmax) 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t) 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC 0-t is defined as AUC from time 0 to the last data point
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞) 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC 0-∞ is defined as area under the concentration vs. time curve from zero to infinity.
Terminal Elimination Half-life (T1/2) 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes T1/2 refers to the time taken for concentration of a drug to decrease from its maximum concentration to half of Cmax
- Secondary Outcome Measures
Name Time Method Total Body Clearance (CL) 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes CL refers to the Dose/AUC 0-∞
Volume of Distribution (Vd) 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes Vd refers to the ratio of amount of drug in a body (dose) to concentration of the drug that is measured in blood, plasma, and un-bound in interstitial fluid.