Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients

American Regent

Status and phase: Completed; Phase 2

Conditions: Anemia

Treatments: Drug: Venofer

Study type: Interventional

Funder types: Industry

Identifiers

NCT00721188

1VEN05033

Details and patient eligibility

About

The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.

Enrollment: 11 patients

Sex: All

Ages: 12 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > or = 12 to < or = 16 years
• Parent and/or legal guardian able to give informed consent
• Subject able to give written assent for participating in the study
• NDD-CKD defined as: kidney damage for 3 months or longer, or GFR < 60 for 3 months or longer
• Hemoglobin indicative of anemia
• Ferritin indicative of iron deficiency anemia
• If appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period

Exclusion criteria

• Known history of hypersensitivity to any component of Venofer
• Parenteral iron within 14 days of the screening visit
• Dialysis dependent-CKD
• Chronic or serious active infection
• Pregnancy or lactation
• Subjects with causes of iron deficiency anemia other than CKD
• Blood transfusion within the last month or anticipated during the study
• Body weight < 55 pounds
• Received an investigational drug within 30 days before screening

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Pharmacokinetic Population

Experimental group

Description:

All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.

Treatment:

Drug: Venofer