A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT)
|ClinicalTrials.gov Identifier: NCT00307814|
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anemia Chronic Renal Insufficiency||Drug: Epoetin Alfa||Phase 2|
Epoetin alfa has been widely utilized as treatment for anemia associated with Chronic Kidney Disease (CKD). Epoetin alfa has been shown to increase hemoglobin (Hb) levels by an average of 1.5 g/dL to 2 g/dL in these patients over 12 weeks (Data on file Ortho Biotech Products, L.P.). This improvement in Hb levels is maintained while the patient is receiving Epoetin alfa and is associated with significant improvements in survival, exercise tolerance, and quality of life. Literature has suggested that epoetin alfa can be given less frequently and still maintain an optimal hemoglobin while also allowing patient's greater convenience. This study will further confirm that less frequent dosing of epoetin alfa is safe and effective. This is an open-label, randomized multicenter study in patients with CKD. CKD patients who are currently receiving PROCRIT therapy for at least 2 months or more and with a stable Hb (>= 11g/dL) will be randomized to one of four treatment groups. A stable Hemoglobin will be defined as a value that is ± 10% for 3 consecutive laboratory values.
This study is designed to demonstrate that there is no meaningful difference in hemoglobin level with more extended dosing regimens as compared to once weekly. A clinically meaningful difference is defined as a difference that is less than 10%. Patients will be randomized to one of 4 treatment groups: All will receive subcutaneous (under the skin) Epoetin alfa for a period of 16 weeks.
Group 1: 10,000 units every week Group 2: 20,000 units every two weeks Group 3: 30,000 units every three weeks Group 4: 40,000 units every four weeks
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||519 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label Clinical Evaluation of PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease|
|Study Start Date :||January 2002|
|Actual Study Completion Date :||January 2004|
- 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.
- The secondary variable is Quality of Life and Hemoglobin Change over Time
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307814
|Study Director:||Ortho Biotech Products, L.P. Clinical Trial||Ortho Biotech Products, L.P.|