CompletedPhase 2

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

United States11 participantsStarted 2006-01

Plain-language summary

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

Who can participate

Age range12 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

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.

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.

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.

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.

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.

Trial details

NCT IDNCT00721188

SponsorAmerican Regent, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-07

Results submitted2011-02-23

View on ClinicalTrials.gov More Anemia trials

Who can participate

Age range12 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

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.

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.

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.

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.

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.