Clinical trial NCT00721188: Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
Official title: Single-Dose Pharmacokinetics of Venofer (Iron Sucrose Injection) in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients Receiving or Not Receiving Erythropoiesis Stimulating Agents (ESA's)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-23
Enrollment: 11
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
measure: Time to Maximum Serum Concentration (Tmax)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
measure: Serum Terminal Phase Elimination Half-life (T1/2)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
measure: Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
measure: Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
measure: Terminal Phase Elimination Rate Constant (λz)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Secondary outcomes:
measure: Total Body Clearance (Cl)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.
measure: Initial Volume of Distribution (Vdc)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
measure: Volume of Distribution Based on the Terminal Phase (Vdarea)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
measure: Volume of Distribution at Steady State (Vdss)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
measure: Mean Residence Time (MRtime)
timeFrame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
measure: Number of Participants With Serious Adverse Events (SAE's)
timeFrame: Day of initial treatment with Venofer through 30 days after study treatment
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals
state: Pennsylvania
Study officials:
References: