Safety and Efficacy of Iron Sucrose in Children

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239642
• Other study ID #: 1VEN03017
• Status: Completed
• Phase: Phase 4
• Start date: July 2005
• Est. completion date: April 2010

Study information

• Verified date: October 2021
• Source: American Regent, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: April 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Venofer (iron sucrose injection)
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
• Venofer (iron sucrose injection)
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
• Venofer (iron sucrose injection)
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Locations

Country	Name	City	State
United States	Luitpold Pharmaceutials	Norristown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
American Regent, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event	Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm	baseline through week 12
Secondary	Number of Subjects Achieving Clinical Success	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)	anytime during the 12 week post-baseline period
Secondary	Percentage (%) of Subjects Achieving Clinical Success	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)	anytime during the 12 week post-baseline period
Secondary	Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive	Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive	anytime during the 12-week post-baseline period
Secondary	Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive	Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive	anytime during the 12 week post-baseline period
Secondary	Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive	Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive	anytime during the 12 week post-baseline period
Secondary	Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive	Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive	anytime during the 12 week post-baseline period
Secondary	Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline	Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline	anytime during the 12 week post-baseline period
Secondary	Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline	Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline	anytime during the 12 week post-baseline period