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

Phase 2

Completed

• Conditions: Anemia
• Interventions: Drug: Venofer

• Registration Number: NCT00721188
• Lead Sponsor: American Regent, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-07
• Study First Submitted: 2008-07-21
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-23
• Study Completion: 2010-01
• Results First Submitted: 2011-02-23
• Results First Submitted QC: 2011-02-23
• Results First Posted: 2011-03-25
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacokinetic Population	Venofer	All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Serum Concentration (Cmax)	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.
Time to Maximum Serum Concentration (Tmax)	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.
Serum Terminal Phase Elimination Half-life (T1/2)	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.
Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)	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.
Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)	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.
Terminal Phase Elimination Rate Constant (λz)	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 Outcome Measures

Name	Time	Method
Total Body Clearance (Cl)	Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.	Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)
Initial Volume of Distribution (Vdc)	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.
Volume of Distribution Based on the Terminal Phase (Vdarea)	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.
Volume of Distribution at Steady State (Vdss)	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.
Mean Residence Time (MRtime)	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.
Number of Participants With Serious Adverse Events (SAE's)	Day of initial treatment with Venofer through 30 days after study treatment

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Norristown, Pennsylvania, United States