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

NCT00680043 | Completed Phase 2 Results

• 1 other identifier: AFX01-15
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 11

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods

  Weeks 1 to 28

• Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods

  Weeks 1 to 28

Study Arms (3)

Peginesatide 0.04 mg/kg

EXPERIMENTAL

Drug: peginesatide

Peginesatide 0.08 mg/kg

EXPERIMENTAL

Drug: peginesatide

Epoetin Alfa

ACTIVE COMPARATOR

Drug: Epoetin Alfa

Interventions

peginesatide DRUG

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).

Also known as: Omontys, Hematide, AF37702 Injection

Peginesatide 0.04 mg/kg

Epoetin Alfa DRUG

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.

Also known as: Eprex

Epoetin Alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affymax: lead
• Takeda: collaborator

Study Sites (11)

Research Facility

Irkutsk, Russia

Location

Research Facility

Krasnodar, Russia

Location

Research Facility

Krasnoyarsk, Russia

Location

Research Facility

Moscow, Russia

Location

Research Facility

Nizhny Novgorod, Russia

Location

Research Facility

Omsk, Russia

Location

Research Facility

Petrozavodsk, Russia

Location

Research Facility

Saint Petersburg, Russia

Location

Research Facility

Saratov, Russia

Location

Research Facility

Tver', Russia

Location

Research Facility

Volzhsk, Russia

Location

MeSH Terms

Conditions

Anemia; Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

peginesatide; hematide; Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Vice President, Clinical Development
• Organization: Affymax

info@affymax.com

650-812-8700

Study Officials

• Vice President, Clinical Development

  Affymax

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 19, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 29, 2012
• Results First Posted: May 30, 2012

Record last verified: 2012-06

Locations

RU (11)