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

Red-Cell Aplasia, Pure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211029
• Other study ID #: CR004405
• Secondary ID: EPO-IMU-401
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 30, 2015
• Start date: January 2003
• Est. completion date: July 2005

Study information

• Verified date: July 2015
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

This is a prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), observational (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions) and cohort study. Study specific information will be collected from participants with chronic renal disease who are receiving recombinant erythropoietin and their treatment course will be followed for up to 2 years and participants will not receive any intervention in this study. Upon entering the study, 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 pure red cell aplasia (PRCA) development. 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. Participants discontinuing erythropoietin will be followed only for an additional 12 months from the time erythropoietin is discontinued. Participants will receive standard-of-care treatment for their chronic renal disease from their individual Investigators. Participants will be primarily observed prospectively for PRCA. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4670
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Red-Cell Aplasia, Pure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Number of Participants With Pure Red Cell Aplasia (PRCA) Associated With Different Routes of Administration	The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.	Every 3 Months up to up to 2 years	No
Secondary	Change From Baseline in Number of Participants With PRCA Over Time	The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.	Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	Number of Participants With Pure Red Cell Aplasia (PRCA) and non-PRCA	Data will be collected from PRCA cases and non-PRCA cases to assist with identification of risk factors for PRCA such as demographic profile and duration of exposure to epoetin alfa or other recombinant erythropoietins.	Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24	No

External 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