A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa

Pure Red-cell Aplasia Clinical Trial

Official title:

Retrospective Case-control Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211068
• Other study ID #: CR004408
• Secondary ID: EPO-IMU-403
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: April 29, 2013
• Start date: March 2004
• Est. completion date: March 2006

Study information

• Verified date: April 2013
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect historical occurrences of risk factors that are potentially associated with the development of anti-erythropoietin (EPO) antibody positive pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been recently treated with epoetin alfa (EPREX).

Description:

This is a multicenter (study conducted at multiple sites), case-control (study that compare individuals with a disease or condition [cases] to a group of individuals without the disease or condition [controls] to determine the possible factor which increased disease incidence), retrospective (a study in which the participants are identified and then followed backward, as time passes) study. Retrospective risk factor data will be collected for control participants matched to the subset of participants in Protocol EPO-IMU-301 identified as having chronic kidney disease and anti-EPO antibody positive PRCA that began while the participant was receiving treatment with EPREX (index participants). For each index participant, up to 4 matched non-PRCA control participants with chronic kidney disease will be enrolled in this study. Approximately 600 control participants will be enrolled in this study. Control participants will be selected from the same site as the index participant and the data will be collected from the date closest to the reference date (loss of efficacy [drop in hemoglobin of greater than 2 g/dL/month] was first seen) that the control participant satisfies all study inclusion and exclusion criteria. The optional pharmacogenomic part (testing for polymorphisms and haploid types of the erythropoietin gene) will be recorded for the control participants who will sign the pharmacogenomics part of the study. No drug administration or treatment will be mandated by this study. Safety evaluation will include assessment of adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• History of anemia due to chronic kidney disease

• Pure red cell aplasia (PRCA) associated with erythropoietin-alpha (EPO) treatment

• Treatment with EPO for a minimum of 2 months occurring within more or less 3 months of the reference date (date of loss of efficacy [drop in hemoglobin of greater than 2 g/dL/month] was first observed)

Exclusion criteria

• History of and information related to past exposure to EPO not available

• History of PRCA or anti-EPO antibody positive status before or after the reference date

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Diseases
• Pure Red-cell Aplasia
• Red-Cell Aplasia, Pure
• Renal Insufficiency, Chronic

Intervention

Drug:
• No intervention
This study is an observational study. No medication will be provided or administered to the participants. Participants will receive standard-of-care treatment from their individual physicians.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Countries where clinical trial is conducted

Brazil,  France,  Norway,  South Africa,  Sweden,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug	The reference date is the day on which Loss of Efficacy (LOE) was first suspected, where LOE is the date that a drop in hemoglobin of greater than 2 g/dL/month was first seen.	1 year prior to the reference date	No
Primary	Study medication-related risk factors: Number of participants who received HSA-free drug		1 year prior to the reference date	No
Primary	Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously		1 year prior to the reference date	No
Primary	Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously		1 year prior to the reference date	No
Primary	Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa		1 year prior to the reference date	No
Primary	Study medication administration-related risk factors: Number of participants who administered epoetin alfa in hospital or in clinic		1 year prior to the reference date	No
Primary	Study medication administration-related risk factors: Number of participants with the duration of epoetin alfa treatment		1 year prior to the reference date	No
Primary	Study medication administration-related risk factors: Number of participants with the duration of other recombinant human erythropoietins (r-HuEPOs) treatment		1 year prior to the reference date	No
Primary	Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa		1 year prior to the reference date	No
Primary	Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs		1 year prior to the reference date	No
Primary	Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing		6 months prior to the reference date	No
Primary	Study medication administration-related risk factors: Number of participants with frequency of other r-HuEPOs dosing		6 months prior to the reference date	No
Primary	Participant-related risk factors: Number of participants according to age		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants according to sex		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants according to race		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants according to type of renal replacement therapy (if any at the time of the reference date)		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with history of malnutrition		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with history of autoimmune disease or positive results of autoimmune testing		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with history of immune dysregulation		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with uncontrolled hypothyroidism		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with history of malignancy		5 years prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with history of viral infection		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with history of vaccination		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with history of frequent transfusions		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with treatment with other subcutaneous medications		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants with treatment with other recombinant human proteins		1 year prior to the reference date	No
Primary	Participant-related risk factors: Number of participants who received other concomitant therapy		1 year prior to the reference date	No
Secondary	Human leukocyte antigen (HLA) typing	The optional pharmacogenomic (use of genetic information to predict whether the study medication will help make a patient well or ill) part of the study will test for polymorphisms and haploid types of the erythropoietin gene. HLA typing will be recorded for the control participants who will sign the pharmacogenomics part of the study.	1 year prior to the reference date	No