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

This study has been withdrawn prior to enrollment.
(The study never started due to zero enrolment)
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210977
First received: September 13, 2005
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Anemia
Drug: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Subjects Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Number of Participants With Presence of Anti-Erythropoietin Antibodies (anti-EPO Ab) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Duration of Effectiveness of Erythropoietin Receptor Agonist Therapy [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Concentration of Plasma Anti Erythropoietin Antibody [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Factors That Forecast Progression to Loss of Effectiveness [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Factors That Forecast Progression to Suspected Pure Red Cell Aplasia [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Factors That Forecast Progression to Confirmed Pure Red Cell Aplasia [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood samples will be collected for pharmacogenomic analysis.


Enrollment: 0
Study Start Date: December 2005
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210977

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210977     History of Changes
Other Study ID Numbers: CR003277, EPO-IMU-302
Study First Received: September 13, 2005
Last Updated: August 29, 2013
Health Authority: United States: None due to the nature of the study

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia
Erythropoietin
Epoetin alfa
Erythropoietin receptor agonist (ERA) therapy
Anti-erythropoietin antibodies (anti-EPO Ab)
Recombinant human erythropoietin
Pure red cell aplasia
Darbepoetin

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Antibodies
Immunoglobulins
Epoetin alfa
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014