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

May 17, 2011 updated by: Ortho Biotech Products, L.P.

A Randomized, Open-Label Clinical Evaluation of PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

519

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

Outcome Measure
The secondary variable is Quality of Life and Hemoglobin Change over Time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ortho Biotech Products, L.P.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

March 24, 2006

First Submitted That Met QC Criteria

March 24, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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