CompletedPhase 2

A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT)

519 participantsStarted 2002-01

Plain-language summary

The purpose of this study is to evaluate the effectiveness and safety of less frequent dosing of PROCRIT (Epoetin alfa) in patients with anemia due to Chronic Kidney Disease (CKD) as assessed by hemoglobin maintenance, adverse events and health-related quality of life.

Who can participate

Age range18 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: * CKD patients (defined as serum creatinine 1.5 to 6.0 mg/dL for women and 2.0 to 6.0 g/mg/dL for men) * Stable Hb (\>= 11.0g/dL) and currently receiving PROCRIT therapy for 2 months or more. A stable Hemoglobin will be defined as a value that is ± 10% for 3 consecutive laboratory values. Exclusion Criteria: * Lactating or pregnant women * Uncontrolled hypertension * Known hypersensitivity to mammalian cell-derived products and human albumin * Receiving dialysis or scheduled to receive dialysis during the course of the study * gastrointestinal bleeding * Severe Congestive Heart Failure (New York Heart Association Class IV) * Concurrent chemotherapy for cancer * History of/or active blood disorders, liver diseases or seizures * HIV positive * Received a kidney transplant

What they're measuring

The primary efficacy variable is hemoglobin maintenance. Also, patients will be assessed for incidence and severity of adverse events and vital signs (blood pressure) during the 16 week study period.

Trial details

NCT IDNCT00307814

SponsorOrtho Biotech Products, L.P.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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