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 range

12 Years – 16 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

12 Years – 16 Years

Sex

ALL

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.