Safety and Efficacy of Iron Sucrose in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00239642
First received: October 13, 2005
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Anemia
Chronic Kidney Disease
Drug: Venofer (iron sucrose injection)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event [ Time Frame: baseline through week 12 ] [ Designated as safety issue: Yes ]
    Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm


Secondary Outcome Measures:
  • Number of Subjects Achieving Clinical Success [ Time Frame: anytime during the 12 week post-baseline period ] [ Designated as safety issue: No ]
    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)

  • Percentage (%) of Subjects Achieving Clinical Success [ Time Frame: anytime during the 12 week post-baseline period ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]
    Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive

  • 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 ] [ Designated as safety issue: No ]
    Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive

  • Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive [ Time Frame: anytime during the 12 week post-baseline period ] [ Designated as safety issue: No ]
    Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive

  • Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive [ Time Frame: anytime during the 12 week post-baseline period ] [ Designated as safety issue: No ]
    Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive

  • 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 ] [ Designated as safety issue: No ]
    Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline

  • 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 ] [ Designated as safety issue: No ]
    Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline


Enrollment: 141
Study Start Date: July 2005
Study Completion Date: April 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venofer (0.5 mg/kg)
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Drug: Venofer (iron sucrose injection)
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Experimental: Venofer (1.0 mg/kg)
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Drug: Venofer (iron sucrose injection)
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Experimental: Venofer (2.0 mg/kg)
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Drug: Venofer (iron sucrose injection)
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239642

Locations
United States, Pennsylvania
Luitpold Pharmaceutials
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Director: David Bregman, M.D., Ph.D. Luitpold Pharmaceuticals
  More Information

No publications provided

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00239642     History of Changes
Other Study ID Numbers: 1VEN03017
Study First Received: October 13, 2005
Results First Received: December 5, 2011
Last Updated: October 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
Iron
Anemia
CKD

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Iron
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014