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

Anemia Clinical Trial

Official title:

An Observational Study of Subjects Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00210977
• Other study ID #: CR003277
• Secondary ID: EPO-IMU-302
• Status: Withdrawn
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 29, 2013
• Start date: December 2005
• Est. completion date: January 2010

Study information

• Verified date: August 2013
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: None due to the nature of the study
• Study type: Observational

Clinical Trial 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.

Description:

This is an observational (study in which the investigators/physicians observe the participant's data and measure their outcomes), international, multicenter (study conducted at multiple sites), cohort (group of individuals with similar characteristics) study. The study consists of prestudy phase, observational phase (2 years), and follow-up phase (1 year). Approximately 50 participants who already receiving ERA therapy for anemia will be observed in this study. In the observational phase, participants' erythropoietin antibody status (positive or negative), clinical progress, treatment for anemia or prevention of anemia, and outcome will be monitored. During this study, enrolled participants will continue to receive standard-of-care treatment for their disease from their individual investigators as before enrollment to this study. Safety evaluations will include assessment of adverse events which will be monitored throughout the study. The total duration of the study will be 3 years.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• No intervention
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.

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 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	No
Primary	Duration of Effectiveness of Erythropoietin Receptor Agonist Therapy		Up to 2 years	No
Secondary	Concentration of Plasma Anti Erythropoietin Antibody		Up to 2 years	No
Secondary	Factors That Forecast Progression to Loss of Effectiveness		Up to 2 years	No
Secondary	Factors That Forecast Progression to Suspected Pure Red Cell Aplasia		Up to 2 years	No
Secondary	Factors That Forecast Progression to Confirmed Pure Red Cell Aplasia		Up to 2 years	No
Secondary	Number of Participants With Adverse Events		Up to 3 years	Yes