A Study to Observe the Number of Patients Who Develop Pure Red Cell Aplasia (PRCA, a Rare Form of Anemia) While Receiving Epoetin Alfa or Other Recombinant Erythropoietins

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00211029
First received: September 13, 2005
Last updated: May 11, 2007
Last verified: May 2007
  Purpose

The purpose of this study is to record the number of patients with chronic renal disease who are receiving treatment with epoetin alfa or other recombinant erythropoietins who develop pure red cell aplasia (PRCA, a rare form of anemia) during the study period.


Condition Phase
Red-Cell Aplasia, Pure
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: An Active Safety Surveillance Plan to Prospectively Monitor the Incidence of Pure Red Cell Aplasia (PRCA) Among Patients Receiving Epoetin Alfa Therapy or Other Recombinant Erythropoietins

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Estimated Enrollment: 15000
Study Start Date: January 2003
Estimated Study Completion Date: July 2005
Detailed Description:

Recombinant erythropoietins are effective in treating anemia caused by many diseases, including chronic renal disease. Pure red cell aplasia (PRCA, a rare form of anemia) and the development of antibodies to erythropoietin have been reported to occur infrequently in patients who are being treated with recombinant erythropoietins. The incidence of PRCA and antibody development is unknown. In this prospective, observational cohort study, specific information will be collected on patients with chronic renal disease who are receiving recombinant erythropoietin and their treatment course will be followed for up to 2 years. The study will be performed as a postmarketing surveillance study. Patients will be treated by their individual physician for their chronic renal disease; no treatment or procedures will be specified and no medication will be given by the Sponsor of the study (Johnson and Johnson Pharmaceutical Research and Development, LLC). Upon entering the study, specific information will be collected regarding disease history and recombinant erythropoietin treatment. Every 3 months thereafter, progress information will be collected, including recombinant erythropoietin treatment, number of red blood cells and presence of any signs of PRCA development. If a confirmed or suspected diagnosis of PRCA is made, the date of diagnosis will also be recorded. Patients who develop PRCA will be offered the opportunity to enroll into another study specifically designed to follow PRCA patients for treatment, outcome and recovery. Patients who discontinue recombinant erythropoietin will be followed only for an additional 12 months from the time recombinant erythropoietin is discontinued. All information will be collected in a confidential manner and identity of the patients will be protected. The results of this study will be combined with a similar study (EPO-IMU-402) that also collects blood samples to observe the number of patients who develop antibodies to erythropoietin. This study will initially enroll only patients with chronic renal disease who are being treated with a recombinant erythropoietin marketed by any of the Johnson and Johnson family of companies but may be expanded to enroll patients with other diseases and who have taken other recombinant erythropoietins. The study hypothesis is that these data will provide a framework for the expansion of the patient population to estimate the incidence of PRCA associated with the use of epoetin alfa or other recombinant erythropoietins for other therapeutic indications.

Since the study is purely an observation of patients who may develop PRCA, no treatment will be required by the Sponsor and no medication will be supplied by the Sponsor. Patients will receive standard-of-care treatment for their chronic renal (or other) disease from their individual physicians.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients of legal age to give consent according to local standards
  • Patients must be receiving or about to receive treatment with an erythropoietin as part of a pre-existing treatment plan for their chronic renal (or other) disease
  • Physicians treating the patients must agree in advance to document any appearance of pure red cell aplasia (PRCA) such that information and details of the case may be reported to regulatory agencies (with patient identification protected)
  • If required by local ethics committees, patients must give consent to permit the collection of de-identified personal data for the specific purpose of this study

Exclusion Criteria:

  • Patients who are unable to complete future follow-up visits
  • Patients who when entering the study have any of the following symptoms of pure red cell aplasia (PRCA): Loss of effectiveness of erythropoietin or low number of immature red blood cells while on erythropoietin as shown by a blood test or bone marrow examination
  • Patients with a history of PRCA or loss of effectiveness with erythropoietin at the time of enrollment into the study
  • Patients whose anemia did not respond to previous treatment with an erythropoietin
  • Patients with a history of antibodies to erythropoietin prior to entering the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211029

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00211029     History of Changes
Other Study ID Numbers: CR004405
Study First Received: September 13, 2005
Last Updated: May 11, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Red Cell Aplasia, Pure Red Cell Aplasia
Anemia, Hemoglobin, Red Blood Cells, Epoetin alfa
Chronic Renal Failure
Kidney Failure
Epoetin
erythropoietin

Additional relevant MeSH terms:
Red-Cell Aplasia, Pure
Anemia
Hematologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014