MedDataX Logo

Safety and Efficacy of Iron Sucrose in Children

NCT ID: NCT00239642

Last Updated: 2021-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia Chronic Kidney Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Iron Anemia CKD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Venofer (0.5 mg/kg)

0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Group Type EXPERIMENTAL

Venofer (iron sucrose injection)

Intervention Type DRUG

0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Venofer (1.0 mg/kg)

1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Group Type EXPERIMENTAL

Venofer (iron sucrose injection)

Intervention Type DRUG

1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Venofer (2.0 mg/kg)

2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Group Type EXPERIMENTAL

Venofer (iron sucrose injection)

Intervention Type DRUG

2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Venofer (iron sucrose injection)

0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Intervention Type DRUG

Venofer (iron sucrose injection)

1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Intervention Type DRUG

Venofer (iron sucrose injection)

2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients between 2 to 21 years of age
* Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months
* Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) \<60
* Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL
* Ferritin ≤ 800 ng/mL
* Transferrin saturation (TSAT) ≥ 20% to ≤ 50%
* Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying screening visit

Exclusion Criteria

* Known hypersensitivity to iron sucrose
* Severe diseased of the liver, cardiovascular system, or hemopoietic system
* Serious infection requiring hospitalization
* Significant blood loss within the last 3 months
* Bleeding disorders
* Pregnancy / Lactation
* Actively being treated for asthma
* Hemoglobinopathy
* Receiving a myelosuppressive drug
Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Regent, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark A Falone, MD

Role: STUDY_DIRECTOR

American Regent, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Luitpold Pharmaceutials

Norristown, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1VEN03017

Identifier Type: -

Identifier Source: org_study_id