A Study of Patients Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies

NCT00210977 | Withdrawn DMC

• 2 other identifiers: CR003277EPO-IMU-302
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the presence of anti erythropoietin antibodies (anti EPO Ab) in participants responding to any erythropoietin receptor agonist (ERA) therapy to treat or prevent anemia without loss of effectiveness to see if they will develop pure red cell aplasia or loss of effectiveness to recombinant erythropoietin and to measure the duration of effectiveness of ERA therapy.

Conditions

Anemia

Keywords

Anemia; Erythropoietin; Epoetin alfa; Erythropoietin receptor agonist (ERA) therapy; Anti-erythropoietin antibodies (anti-EPO Ab); Recombinant human erythropoietin; Pure red cell aplasia; Darbepoetin

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Presence of Anti-Erythropoietin Antibodies (anti-EPO Ab)

  An antibody is a large Y-shaped protein secreted into the blood and is used by the immune system to identify and neutralize foreign objects such as bacteria and viruses. Presence of anti-EPO Ab will help to find out participant's progress to the outcomes loss of effectiveness, suspected pure red cell aplasia, or confirmed pure red cell aplasia.

  Up to 2 years

• Duration of Effectiveness of Erythropoietin Receptor Agonist Therapy

  Up to 2 years

Secondary Outcomes (5)

• Concentration of Plasma Anti Erythropoietin Antibody

  Up to 2 years

• Factors That Forecast Progression to Loss of Effectiveness

  Up to 2 years

• Factors That Forecast Progression to Suspected Pure Red Cell Aplasia

  Up to 2 years

• Factors That Forecast Progression to Confirmed Pure Red Cell Aplasia

  Up to 2 years

• Number of Participants With Adverse Events

  Up to 3 years

Study Arms (1)

Erythropoietin receptor agonist

Participants with borderline serum anti erythropoietin (EPO) antibody (Ab) titers and who are treated with any erythropoietin receptor agonist (ERA) for any indication, having anti-EPO Ab identified by radioimmunoprecipitation (RIP), who are responding to ERA therapy, will be included in the study.

Drug: No intervention

Interventions

No intervention DRUG

This is an observational study. All participants will be maintained on their regular dose regimen of standard-of-care treatment, under the guidance of the treating physician/investigator.

Erythropoietin receptor agonist

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 with positive or borderline serum anti erythropoietin antibody titer and who are responding to any erythropoietin receptor agonist (ERA) therapy for any cause of anemia

You may qualify if:

• Receiving any ERA therapy for any cause of anemia and having responded to the ERA therapy for at least 3 months
• Positive or borderline serum for antibodies to erythropoietin identified by serum radioimmunoprecipitation
• Maintained a stable hemoglobin within a 3-month period that has not decreased more than 2 g/dL in any 1-month period and with no increase in red blood cell transfusion requirement
• An ERA maintenance dose that has not increased more than 50 percentages from initial effective dose
• If blood count information is available, must have a count of reticulocytes (immature red blood cells) greater than or equal to 30 million/L

You may not qualify if:

• Stem cell or bone marrow transplantation
• Treatment with medication that decreases the ability of the immune system to function normally, within the last 3 months
• Participants who have shown a loss of effectiveness to ERA therapy, defined as participants who initially responded to treatment for anemia \[a rise in hemoglobin which lasted for a minimum of 3 months\] followed by an unexplained decrease in hemoglobin (greater than or equal to 2 g/dL) within a 1-month period

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for pharmacogenomic analysis.

MeSH Terms

Conditions

Anemia; Arthritis, Juvenile; Red-Cell Aplasia, Pure

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

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: December 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 2, 2013

Record last verified: 2013-08