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

NCT00211029 | Completed

• 2 other identifiers: CR004405EPO-IMU-401
• Study Type: observational
• Target: 4,670
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to record the number of participants 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.

Conditions

Red-Cell Aplasia, Pure

Keywords

Anemia, Hemoglobin, Red Blood Cells, Epoetin alfa; Epoetin; erythropoietin; Red Cell Aplasia, Pure Red Cell Aplasia; Chronic Renal Failure; Kidney Failure

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Pure Red Cell Aplasia (PRCA)

  The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.

  Up to 2 years

• Number of Participants With Positive Serum Erythropoietin (EPO) Antibodies Development Associated With Different Routes of Administration

  Antibodies are immunoglobulin molecules having a specific amino acid sequence by virtue of which they interact only with the antigen (or a very similar shape) that induced their synthesis in cells of the lymphoid series.

  Up to 2 years

• Relationship between EPO Antibodies and PRCA

  Natural history of EPO antibodies will be examined and its relationship to PRCA will be checked.

  Up to 2 years

Secondary Outcomes (3)

• Number of Participants With Pure Red Cell Aplasia (PRCA) Associated With Different Routes of Administration

  Every 3 Months up to up to 2 years

• Change From Baseline in Number of Participants With PRCA Over Time

  Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24

• Number of Participants With Pure Red Cell Aplasia (PRCA) and non-PRCA

  Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24

Study Arms (1)

Participants Receiving Epoetin Alfa or Another Erythropoietin

Participants will not receive any intervention in this study. Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins will be prospectively observed to monitor incidence of pure red cell aplasia and/or antibodies to erythropoietin. Participants will receive standard-of-care treatment for their chronic renal (or other) disease from their individual Investigators.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• An Active Safety Surveillance Plan to Prospectively Monitor the Incidence of Pure Red Cell Aplasia (PRCA) Among Patients Receiving Epoetin Alfa Therapy or Other Erythropoietins

MeSH Terms

Conditions

Red-Cell Aplasia, Pure; Anemia; Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2003
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: July 31, 2015

Record last verified: 2015-07