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Completed

NCT Number: NCT00239642

Safety and Efficacy of Iron Sucrose in Children

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

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Key information

Conditions

Anemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Luitpold Pharmaceutials

Norristown, Pennsylvania, 19403, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venofer (iron sucrose injection)

Drug

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

Primary outcomes

  1. Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event

    Time frame: baseline through week 12

    Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm

Secondary outcomes

  1. Number of Subjects Achieving Clinical Success

    Time frame: anytime during the 12 week post-baseline period

    Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose)

  2. Percentage (%) of Subjects Achieving Clinical Success

    Time frame: anytime during the 12 week post-baseline period

    Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose)

  3. Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive

    Time frame: anytime during the 12-week post-baseline period

    Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive

  4. Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive

    Time frame: anytime during the 12 week post-baseline period

    Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive

  5. Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive

    Time frame: anytime during the 12 week post-baseline period

    Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive

  6. Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive

    Time frame: anytime during the 12 week post-baseline period

    Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive

  7. Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline

    Time frame: anytime during the 12 week post-baseline period

    Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline

  8. Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline

    Time frame: anytime during the 12 week post-baseline period

    Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Oct 17, 2005
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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