CompletedPhase 3

PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

United States430 participantsStarted 2007-07

Plain-language summary

The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) \>=15 mL/min per 1.73 m2 and \<60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory * Hemoglobin level between 10.0 and 11.9 g/dL during the 4 weeks before randomization * History of increase in hemoglobin after the initial dose * Stable dose of epoetin alfa given once-weekly before randomization. Exclusion Criteria: * Uncontrolled hypertension * Iron deficiency * iron overload * severe congestive heart failure * Active infection * Recent heart attack, Stroke or blood clot.

What they're measuring

Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment

Timeframe: from baseline (Week 1) to the last 12 weeks of treatment

Trial details

NCT IDNCT00440466

SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-03

Results submitted2010-05-13

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