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

NCT00211068 | Completed DMC

• 2 other identifiers: CR004408EPO-IMU-403
• Study Type: observational
• Target: 124
• Locations: 7 countries
• Sites: 22

Brief 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).

Conditions

Pure Red-cell Aplasia

Keywords

Pure red-cell aplasia; Chronic kidney failure; Epoetin alfa (Eprex); Erythropoietin; Kidney disease; Anemia

Outcome Measures

Primary Outcomes (30)

• 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

• Study medication-related risk factors: Number of participants who received HSA-free drug

  1 year prior to the reference date

• Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously

  1 year prior to the reference date

• Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously

  1 year prior to the reference date

• Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa

  1 year prior to the reference date

• 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

• Study medication administration-related risk factors: Number of participants with the duration of epoetin alfa treatment

  1 year prior to the reference date

• 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

• Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa

  1 year prior to the reference date

• Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs

  1 year prior to the reference date

• Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing

  6 months prior to the reference date

• Study medication administration-related risk factors: Number of participants with frequency of other r-HuEPOs dosing

  6 months prior to the reference date

• Participant-related risk factors: Number of participants according to age

  1 year prior to the reference date

• Participant-related risk factors: Number of participants according to sex

  1 year prior to the reference date

• Participant-related risk factors: Number of participants according to race

  1 year prior to the reference date

• Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease

  1 year prior to the reference date

• 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

• Participant-related risk factors: Number of participants with history of malnutrition

  1 year prior to the reference date

• 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

• Participant-related risk factors: Number of participants with history of immune dysregulation

  1 year prior to the reference date

• Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism

  1 year prior to the reference date

• Participant-related risk factors: Number of participants with uncontrolled hypothyroidism

  1 year prior to the reference date

• Participant-related risk factors: Number of participants with history of malignancy

  5 years prior to the reference date

• Participant-related risk factors: Number of participants with history of viral infection

  1 year prior to the reference date

• Participant-related risk factors: Number of participants with history of vaccination

  1 year prior to the reference date

• Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy

  1 year prior to the reference date

• Participant-related risk factors: Number of participants with history of frequent transfusions

  1 year prior to the reference date

• Participant-related risk factors: Number of participants with treatment with other subcutaneous medications

  1 year prior to the reference date

• Participant-related risk factors: Number of participants with treatment with other recombinant human proteins

  1 year prior to the reference date

• Participant-related risk factors: Number of participants who received other concomitant therapy

  1 year prior to the reference date

Secondary Outcomes (1)

• Human leukocyte antigen (HLA) typing

  1 year prior to the reference date

Study Arms (1)

Epoetin alfa

Four control patients will be matched to each index patients enrolled in protocol EPO-IMU-301 identified as having chronic kidney disease and an immune-mediated cause of pure red cell aplasia (PRCA) indicated by the presence of anti-erythropoietin (EPO) antibodies in their serum at the time of loss of efficacy.

Drug: No intervention

Interventions

No intervention DRUG

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.

Also known as: EPREX

Epoetin alfa

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants having chronic kidney disease and an immune-mediated cause of pure red cell aplasia indicated by the presence of anti-erythropoietin antibodies in their serum at the time of loss of efficacy

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (22)

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Sorocaba, Brazil

Location

Unknown Facility

Bois-Guillaume, France

Location

Unknown Facility

Grenoble, France

Location

Unknown Facility

Nantes, France

Location

Unknown Facility

Orléans, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Tvnsberg, Norway

Location

Unknown Facility

Bloemfontein, South Africa

Location

Unknown Facility

Karlshamn, Sweden

Location

Unknown Facility

Stockholm, Sweden

Location

Unknown Facility

Trollhättan, Sweden

Location

Unknown Facility

Vlissingen, Thailand

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Brighton, United Kingdom

Location

Unknown Facility

Bristol, United Kingdom

Location

Unknown Facility

Chelmsford, United Kingdom

Location

Unknown Facility

Edinburgh, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Omagh, United Kingdom

Location

Unknown Facility

Westcliff-on-Sea, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample collected for pharmacogenomic analysis

MeSH Terms

Conditions

Red-Cell Aplasia, Pure; Kidney Failure, Chronic; Kidney Diseases; Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; 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

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2004
• Study Completion: March 1, 2006
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

TH (1); NO (1); BR (2); ZA (1); SE (3); FR (5); GB (9)