A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT)
Information source: Ortho Biotech Products, L.P.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Renal Insufficiency; Anemia
Intervention: Epoetin Alfa (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Ortho Biotech Products, L.P. Official(s) and/or principal investigator(s):
Ortho Biotech Products, L.P. Clinical Trial, Study Director, Affiliation: Ortho Biotech Products, L.P.
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: The secondary variable is Quality of Life and Hemoglobin Change over Time
Detailed description:
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
A Randomized, Open-label Clinical Evaluation of PROCRIT (Epoetin ala) for Maintenance Phase Treatment of Patients with Anemia due to Chronic Kidney Disease (PROMPT Study)
Starting date: January 2002
Ending date: January 2004
Last updated: March 17, 2008
|
