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

Anemia Clinical Trial

Official title:

An Open-Label, Multi-Center, Extension Study to Evaluate the Safety and Tolerability of Peginesatide for the Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00453973
• Other study ID #: AFX01-10
• Secondary ID: 2006-003846-41
• Status: Terminated
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: June 22, 2012
• Start date: November 2006
• Est. completion date: September 2009

Study information

• Verified date: June 2012
• Source: Affymax
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeBulgaria: Bulgarian Drug AgencyBulgaria: Ethics committeeRomania: National Medicines AgencyRomania: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: The Central Register of Clinical TrialsPoland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 subjects with chronic kidney disease, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia associated 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.

Study participants had received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study and were to receive doses of peginesatide for up to 54 months. However, the Sponsor ended the study early.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety 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 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.
• peginesatide
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 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.

Locations

Country	Name	City	State
Bulgaria	Research Facility	Burgas
Bulgaria	Research Facility	Pleven
Bulgaria	Research Facility	Plovdiv
Bulgaria	Research Facility	Rousse
Bulgaria	Research Facility	Varna
Bulgaria	Research Facility	Veliko Tarnovo
Poland	Research Facility	Bialystok
Poland	Research Facility	Katowice
Poland	Research Facility	Lódz
Romania	Research Facility	Arad
Romania	Research Facility	Bacau
Romania	Research Facility	Bucuresti
Romania	Research Facility	Iasi
Romania	Research Facility	Timisoara
United Kingdom	Research Facility	Croydon
United Kingdom	Research Facility	Derby
United Kingdom	Research Facility	London
United Kingdom	Research Facility	London
United Kingdom	Research Facility	London
United Kingdom	Research Facility	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Affymax

Countries where clinical trial is conducted

Bulgaria,  Poland,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No