Status:
COMPLETED
Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA
Lead Sponsor:
Affymax
Collaborating Sponsors:
Takeda
Conditions:
Anemia
Chronic Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any trea...
Detailed Description
Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors inc...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- On hemodialysis for chronic renal failure for at least 2 weeks prior to randomization.
- Two consecutive hemoglobin values of ≥ 8.0 g/dL and \< 11.0 g/dL within the 4 weeks prior to randomization.
- Exclusion Criteria
- Females who are pregnant or breast-feeding.
- Prior treatment with an erythropoiesis stimulating agent (ESA) in the 12 weeks prior to randomization.
- Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
- Known bleeding or coagulation disorder.
- Known hematologic disease or cause for anemia other than renal disease
- Poorly controlled hypertension.
- Evidence of active malignancy within one year.
- A scheduled kidney transplant.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00680043
Start Date
June 1 2008
End Date
August 1 2009
Last Update
June 29 2012
Active Locations (11)
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1
Research Facility
Irkutsk, Russia
2
Research Facility
Krasnodar, Russia
3
Research Facility
Krasnoyarsk, Russia
4
Research Facility
Moscow, Russia