ClinicalTrials.Veeva

Menu

Safety and Efficacy of Iron Sucrose in Children

American Regent logo

American Regent

Status and phase

Completed
Phase 4

Conditions

Chronic Kidney Disease
Anemia

Treatments

Drug: Venofer (iron sucrose injection)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00239642
1VEN03017

Details and patient eligibility

About

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

Full 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)

Enrollment

141 patients

Sex

All

Ages

2 to 21 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

141 participants in 3 patient groups

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems