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

NCT00721188 | Completed Phase 2 Results

• 1 other identifier: 1VEN05033
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anemia

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• 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.

• 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.

Study Arms (1)

Pharmacokinetic Population

EXPERIMENTAL

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

Drug: Venofer

Interventions

Venofer DRUG

Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.

Pharmacokinetic Population

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Mark A. Falone, MD
• Organization: Luitpold Pharmaceuticals, Inc.

mfalone@luitpold.com

610-650-4200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: January 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: January 1, 2010
• Last Updated: February 20, 2018
• Results First Posted: March 25, 2011

Record last verified: 2018-01

Locations

US (1)