Clinical trial NCT00239642: Safety and Efficacy of Iron Sucrose in Children
Official title: Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Chronic Kidney Disease
Keywords: Iron
Anemia
CKD
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 141
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event
timeFrame: baseline through week 12
Secondary outcomes:
measure: Number of Subjects Achieving Clinical Success
timeFrame: anytime during the 12 week post-baseline period
measure: Percentage (%) of Subjects Achieving Clinical Success
timeFrame: anytime during the 12 week post-baseline period
measure: Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
timeFrame: anytime during the 12-week post-baseline period
measure: Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
timeFrame: anytime during the 12 week post-baseline period
measure: Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive
timeFrame: anytime during the 12 week post-baseline period
measure: Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive
timeFrame: anytime during the 12 week post-baseline period
measure: Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline
timeFrame: anytime during the 12 week post-baseline period
measure: Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline
timeFrame: anytime during the 12 week post-baseline period
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceutials
state: Pennsylvania
Study officials:
affiliation: American Regent, Inc.
name: Mark A Falone, MD
role: STUDY_DIRECTOR
References: