Pharmacokinetic of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239616

Enrollment

Registered

2005-10-17

Start date

2002-06-05

Completion date

2003-09-15

Last updated

2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Anemia, Pharmacokinetics

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.

Interventions

DRUGIron Sucrose injection

Iron sucrose 100 mg dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

Inclusion criteria

* 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 criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026