CompletedPhase 3

Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

United States145 participantsStarted 2005-06

Plain-language summary

The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).

Who can participate

Age range12 Years

SexALL

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

Inclusion Criteria: * Subjects who completed or discontinued Protocol 1VIT04004 Exclusion Criteria: * Known hypersensitivity reaction to VIT-45 * Anemia not related to CKD * Chronic, serious infection * Recent IV iron other than study drug in past 12 weeks * Recent blood loss within the last 12 weeks * Need for surgery or dialysis * Female subjects who are pregnant or lactating

What they're measuring

Incidence of Treatment-emergent Adverse Events

Timeframe: 44 week study duration

Trial details

NCT IDNCT00317226

SponsorAmerican Regent, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-03

Results submitted2013-09-16

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