A Phase 2, Open-label, Multi-center, Sequential Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Multiple Doses of Subcutaneously Administered Peginesatide in Chronic Kidney Disease Patients Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment

Affymax2 sites in 1 country139 target enrollmentSeptember 2005

ConditionsAnemia Chronic Kidney Disease Chronic Renal Failure

Interventionspeginesatide

Drugspeginesatide

Overview

Phase: Phase 2
Intervention: peginesatide
Conditions: Anemia
Sponsor: Affymax
Enrollment: 139
Locations: 2
Primary Endpoint: Percentage of participants who achieved a target hemoglobin response during the study.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants with chronic kidney disease (CKD) not on dialysis who had not received erythropoiesis stimulating agent (ESA) treatment.

Detailed Description

This was a Phase 2, dose finding study designed to evaluate peginesatide treatment of participants with CKD not on ESA treatment. The objective was to determine the range of doses of peginesatide administered subcutaneously once every 4 weeks (Q4W) that increased and maintained hemoglobin at 11 to 13 g/dL.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

November 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Affymax

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 and ≤ 85 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 an adequate form of contraception for at least 4 weeks prior to study start, and must be willing to continue contraception for at least 4 weeks after the last dose of study drug;
•Chronic kidney disease stage 3 or 4 (estimated Glomerular filtration rate \[GFR\] of 15-60 mL/min within 28 days prior to study drug administration) and not expected to begin dialysis for at least 12 weeks;
•Two hemoglobin values of ≥ 9.0 and \< 11.0 g/dL within 14 days prior to study drug administration, including at least one of the values drawn within 7 days prior to study drug administration;
•One serum ferritin level ≥ 100 micrograms per liter (μg/L) and transferrin saturation ≥ 20 % within 4 weeks prior to study drug administration;
•One serum or red cell folate level above lower limit of normal within 4 weeks prior to study drug administration;
•One vitamin B12 level above lower limit of normal within 4 weeks prior to study drug administration;
•Weight ≥ 45 kg within 4 weeks prior to study drug administration;
•One white blood cell count ≥ 3.0 x 10\^9/L within 4 weeks prior to study drug administration; and
•One platelet count ≥ 100 x 10\^9/L within 4 weeks prior to study drug administration.

Exclusion Criteria

•Prior treatment with any erythropoiesis stimulating agent in the 12 weeks prior to study drug administration;
•Any prior treatment with Eprex®;
•Known intolerance to any erythropoiesis stimulating agent;
•History of antibodies to any erythropoiesis stimulating agent or history of pure red cell aplasia;
•Prior hemodialysis or peritoneal dialysis treatment;
•Known intolerance to parenteral iron supplementation;
•Red blood cell transfusion within 12 weeks prior to study drug administration;
•Hemoglobinopathy \[e.g., homozygous sickle-cell disease (sickle-cell trait does not exclude patient), thalassemia of all types, etc.\];
•Known hemolysis;
•Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);

Arms & Interventions

Cohort 1

Peginesatide starting dose of 0.05 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses.