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

Primary Purpose

Anemia

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

iron sucrose injection USP

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Pharmacokinetics

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 12 and 18 History of Chronic Renal Failure requiring HD or PD Hgb </= 13 g/dL Ferritin < 800 ng/ml TSAT < 50% Receiving EPO 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 KG Currently being treated for Asthma Received investigational drug within last 30 days

Sites / Locations

Outcomes

Primary Outcome Measures

Pharmacokinetic Parameters

Secondary Outcome Measures

Incidence of safety events

Full Information

NCT ID

NCT00239616

First Posted

October 13, 2005

Last Updated

January 22, 2018

Sponsor

American Regent, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00239616

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

American Regent, Inc.

4. Oversight

5. Study Description

Brief Summary

This is an open-label, multicenter pharmacokinetic study of HD od 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

Keywords

Anemia, Pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

iron sucrose injection USP

Primary Outcome Measure Information:

Title

Pharmacokinetic Parameters

Secondary Outcome Measure Information:

Title

Incidence of safety events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark A Falone, MD

Organizational Affiliation

American Regent, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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