Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA

• ClinicalTrials.gov Identifier: NCT00680043
• Recruitment Status: Completed
• First Posted: May 19, 2008
• Results First Posted: May 30, 2012
• Last Update Posted: June 29, 2012
• Sponsor: Affymax
• Collaborator: Takeda
• Information provided by (Responsible Party): Affymax

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anemia; Chronic Renal Failure; Chronic Kidney Disease	Drug: peginesatide; Drug: Epoetin Alfa	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2008
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Peginesatide 0.04 mg/kg	Drug: peginesatide; Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).; Other Names: Omontys; Hematide; AF37702 Injection
Experimental: Peginesatide 0.08 mg/kg	Drug: peginesatide; Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.; Other Names: Omontys; Hematide; AF37702 Injection
Active Comparator: Epoetin Alfa	Drug: Epoetin Alfa; Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.; Other Name: Eprex

Outcome Measures

Primary Outcome Measures :

1. Mean Change in Hemoglobin Between Baseline and the Evaluation Period [ Time Frame: Baseline and Weeks 21-28 ]
   The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28.

Secondary Outcome Measures :

1. Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods [ Time Frame: Weeks 1 to 28 ]
2. Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods [ Time Frame: Weeks 1 to 28 ]
   A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Russian Federation

Research Facility

Irkutsk, Russian Federation

Research Facility

Krasnodar, Russian Federation

Research Facility

Krasnoyarsk, Russian Federation

Research Facility

Moscow, Russian Federation

Research Facility

Nizhniy Novgorod, Russian Federation

Research Facility

Omsk, Russian Federation

Research Facility

Petrozavodsk, Russian Federation

Research Facility

Saratov, Russian Federation

Research Facility

St. Petersburg, Russian Federation

Research Facility

Tver, Russian Federation

Research Facility

Volzhsk, Russian Federation

Sponsors and Collaborators

Affymax

Takeda

Investigators

• Study Director: Vice President, Clinical Development; Affymax

More Information

• Responsible Party: Affymax
• ClinicalTrials.gov Identifier: NCT00680043
• Other Study ID Numbers: AFX01-15
• First Posted: May 19, 2008
• Results First Posted: May 30, 2012
• Last Update Posted: June 29, 2012
• Last Verified: June 2012

Keywords provided by Affymax:

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

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia; Hematologic Diseases; Urologic Diseases; Epoetin Alfa; Hematinics