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Safety and Efficacy of Iron Sucrose in Children

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ClinicalTrials.gov Identifier: NCT00239642
Recruitment Status : Completed
First Posted : October 17, 2005
Results First Posted : January 10, 2012
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals

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

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

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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239642


Locations
United States, Pennsylvania
Luitpold Pharmaceutials
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Director: Mark A Falone, MD Luitpold Pharmaceuticals

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00239642     History of Changes
Other Study ID Numbers: 1VEN03017
First Posted: October 17, 2005    Key Record Dates
Results First Posted: January 10, 2012
Last Update Posted: February 20, 2018
Last Verified: January 2018

Keywords provided by Luitpold Pharmaceuticals:
Iron
Anemia
CKD

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