Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD

NCT00372489 | Terminated Phase 2 Results

• 1 other identifier: AFX01-09
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.

Conditions

Chronic Renal Failure; Chronic Kidney Disease; Anemia

Keywords

anemia; chronic kidney disease; CKD; chronic renal failure; CRF; dialysis; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; Hematide™; hemodialysis; hemoglobin; Hb; Hgb; Omontys; peginesatide; red blood cell; red blood cell production

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change

  Up to 54 months

Study Arms (1)

Peginesatide

EXPERIMENTAL

Drug: peginesatide

Interventions

peginesatide DRUG

Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.

Also known as: Omontys, Hematide, AF37702 Injection

Peginesatide

Eligibility Criteria

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

You may qualify if:

• Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines
• Males or females ≥ 18 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study drug administration, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug.
• Participant who has received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study
• One hemoglobin value of \> 10.0 g/dL in the 4 weeks prior to study drug administration

You may not qualify if:

• Known intolerance to peginesatide or pegylated products
• History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure red cell aplasia (PRCA)
• High likelihood of early withdrawal or interruption of the study (e.g., participant suffers from any clinically significant medical disease or condition that may, in the Investigator's opinion, interfere with safety, assessment, or follow-up of the participant)
• Anticipated life expectancy \< 18 months
• Receipt of any ESA other than peginesatide at any time after participant enrollment in the previous Affymax-sponsored study

Sponsors & Collaborators

• Affymax: lead

Study Sites (9)

Research Facility

Pine Bluff, Arkansas, 71603, United States

Location

Research Facility

Mountain View, California, 94041, United States

Location

Research Facility

Lauderdale Lakes, Florida, 33313, United States

Location

Research Facility

Pembroke Pines, Florida, 33028, United States

Location

Research Facility

Shreveport, Louisiana, 71101, United States

Location

Research Facility

Detroit, Michigan, 48202, United States

Location

Research Facility

Canton, Ohio, 44718, United States

Location

Research Facility

Nashville, Tennessee, 37205, United States

Location

Research Facility

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Anemia

Interventions

peginesatide; hematide

Condition Hierarchy (Ancestors)

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; Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

Early termination of study due to generation of controlled long-term data in Phase 3 studies. Amended dosing guidelines during the trial to reflect label changes for ESAs; the primary outcome was assessed after the dosing guideline change.

Results Point of Contact

• Title: VP, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 7, 2006
• Study Start: September 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 29, 2012
• Results First Posted: May 28, 2012

Record last verified: 2012-06

Locations

US (9)