Clinical trial NCT00680043: Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA
Official title: AFX01-15: A Phase 2, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Undergoing Hemodialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Chronic Renal Failure
Chronic Kidney Disease
Keywords: anemia
chronic kidney disease
CKD
chronic renal failure
CRF
erythropoietin
EPO
erythropoiesis stimulating agent
ESA
Hematide™
hemoglobin
Hb
Hgb
Omontys
peginesatide
red blood cell
red blood cell production
Lead sponsor: Affymax
Sponsor class: INDUSTRY
Collaborators: name: Takeda
First posted: 2008-05-19
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treatment to increase their red blood cell production.

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 include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure.

Erythropoiesis stimulating agents (ESAs) have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia in patients with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.

Eligible participants were randomized in equal proportions to two peginesatide treatment regimens, in which participants received peginesatide once every 4 weeks, and one control, epoetin alfa, treatment regimen, in which participants received epoetin alfa three times per week. Total commitment time of this study was a 4 week screening period followed by a minimum of 7 months of treatment.

Eligibility criteria: Inclusion Criteria

1. On hemodialysis for chronic renal failure for at least 2 weeks prior to randomization.
2. Two consecutive hemoglobin values of ≥ 8.0 g/dL and \< 11.0 g/dL within the 4 weeks prior to randomization.

Exclusion Criteria

1. Females who are pregnant or breast-feeding.
2. Prior treatment with an erythropoiesis stimulating agent (ESA) in the 12 weeks prior to randomization.
3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
4. Known bleeding or coagulation disorder.
5. Known hematologic disease or cause for anemia other than renal disease
6. Poorly controlled hypertension.
7. Evidence of active malignancy within one year.
8. A scheduled kidney transplant.

Primary outcomes:
measure: Mean Change in Hemoglobin Between Baseline and the Evaluation Period
timeFrame: Baseline and Weeks 21-28
Secondary outcomes:
measure: Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods
timeFrame: Weeks 1 to 28
measure: Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods
timeFrame: Weeks 1 to 28
Other outcomes:
Locations:
city: Irkutsk
country: Russian Federation
facility: Research Facility
city: Krasnodar
country: Russian Federation
facility: Research Facility
city: Krasnoyarsk
country: Russian Federation
facility: Research Facility
city: Moscow
country: Russian Federation
facility: Research Facility
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Facility
city: Omsk
country: Russian Federation
facility: Research Facility
city: Petrozavodsk
country: Russian Federation
facility: Research Facility
city: Saratov
country: Russian Federation
facility: Research Facility
city: St. Petersburg
country: Russian Federation
facility: Research Facility
city: Tver
country: Russian Federation
facility: Research Facility
city: Volzhsk
country: Russian Federation
facility: Research Facility
Study officials:
affiliation: Affymax
name: Vice President, Clinical Development
role: STUDY_DIRECTOR
References: