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

NCT00453973 | Terminated Phase 2 Results

• 2 other identifiers: AFX01-102006-003846-41
• Study Type: interventional
• Target: 114
• Locations: 4 countries
• Sites: 20

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 Final Dosing Guideline Change

  Up to 54 months

Study Arms (2)

Maintenance Switch in Dialysis Participants

EXPERIMENTAL

Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status at the start of or during this study.

Drug: peginesatide

Treatment Initiation in Non-Dialysis Participants

EXPERIMENTAL

Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). This group is categorized as "Initiation of Treatment in Non-Dialysis Participants" regardless of dialysis status at the start of or during this study.

Drug: peginesatide

Interventions

peginesatide DRUG

Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.

Also known as: Omontys, Hematide, AF37702 Injection

Maintenance Switch in Dialysis Participants

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, informed consent in accordance with institutional, local, and national guidelines.
• Males or females ≥ 18 years of age.
• Premenopausal 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 grams per deciliter (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 (20)

Research Facility

Burgas, 8000, Bulgaria

Location

Research Facility

Pleven, 5800, Bulgaria

Location

Research Facility

Plovdiv, 4003, Bulgaria

Location

Research Facility

Rousse, 7002, Bulgaria

Location

Research Facility

Varna, 9010, Bulgaria

Location

Research Facility

Veliko Tarnovo, 5000, Bulgaria

Location

Research Facility

Bialystok, 15-540, Poland

Location

Research Facility

Katowice, 40-027, Poland

Location

Research Facility

Lodz, 90-153, Poland

Location

Research Facility

Arad, 310017, Romania

Location

Research Facility

Bacau, 600114, Romania

Location

Research Facility

Bucharest, 014461, Romania

Location

Research Facility

Iași, 700506, Romania

Location

Research Facility

Timișoara, 300736, Romania

Location

Research Facility

Croydon, CR7 7YE, United Kingdom

Location

Research Facility

Derby, DE22 3NE, United Kingdom

Location

Research Facility

London, E1 1BB, United Kingdom

Location

Research Facility

London, SES 9RS, United Kingdom

Location

Research Facility

London, SW17 0QT, United Kingdom

Location

Research Facility

Swansea, SA6 6NL, United Kingdom

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: 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 29, 2007
• Study Start: November 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 29, 2012
• Results First Posted: May 28, 2012

Record last verified: 2012-06

Locations

RO (5); GB (6); BU (6); PL (3)