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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680043
• Other study ID #: AFX01-15
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2008
• Last updated: June 22, 2012
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: June 2012
• Source: Affymax
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Ethics CommitteeRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Chronic Renal Failure
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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).
• 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.
• 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.

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Affymax	Takeda

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Hemoglobin Between Baseline and the Evaluation Period	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.	Baseline and Weeks 21-28	No
Secondary	Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods		Weeks 1 to 28	No
Secondary	Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods	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.	Weeks 1 to 28	No