A Phase 2, Open-label, Multi-center, Sequential, Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Peginesatide Administered Intravenously for the Maintenance Treatment of Anemia in Chronic Hemodialysis Patients

Affymax1 site in 1 country165 target enrollmentJuly 2005

ConditionsAnemia Chronic Kidney Disease Chronic Renal Failure

Interventionspeginesatide

Drugspeginesatide

Overview

Phase: Phase 2
Intervention: peginesatide
Conditions: Anemia
Sponsor: Affymax
Enrollment: 165
Locations: 1
Primary Endpoint: Average weekly hemoglobin and hemoglobin change from baseline
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 is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with chronic kidney disease (CKD) who are on hemodialysis.

Detailed Description

This was a Phase 2, multicenter, open-label, sequential, dose-finding trial designed with up to 12 treatment cohorts of 15 participants per cohort. Each participant received an intravenous dose of peginesatide administered once every 4 weeks (Q4W) for a total of 6 doses. Dosage regimens varied by cohort. Participants were followed for a minimum of 42 days after the last administration of peginesatide.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

May 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 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 start, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence (only acceptable if practiced as a life-style and not acceptable if one who is sexually active practices abstinence only for the duration of the study) or vasectomized partner;
•Clinically stable on hemodialysis for ≥6 months prior to study drug administration;
•Urea clearance/volume (Kt/V) ≥ 1.2 within the 4 weeks prior to study drug administration;
•Epoetin alfa maintenance therapy of ≥ 60 and ≤ 375 U/kg/wk continuously prescribed for 8 weeks prior to study drug administration. In the last 3 weeks prior to study drug administration, variation in prescribed total weekly dose must be ≤ 25% from the mean of the last three prescribed total weekly doses;
•Three mid- or end-of-week hemoglobin values of ≥ 10.0 and ≤ 12.5 g/dL in the 3 weeks prior to study drug administration with ≤ 1.2 g/dL difference between the three values;
•One serum ferritin level ≥ 100 micrograms per liter (μg/L) or one transferrin saturation ≥ 20% or one reticulocyte hemoglobin content (CHr) ≥ 29 picograms within 4 weeks prior to study drug administration;
•One serum folate level above the lower limit of normal during the 4 weeks prior to study drug administration;
•One vitamin B12 level above the lower limit of normal during the 4 weeks prior to study drug administration;
•Weight ≥ 45 kilograms (kg) within the 4 weeks prior to study drug administration;

Exclusion Criteria

•Known intolerance to erythropoiesis stimulating agents;
•History of antibodies to erythropoiesis stimulating agents or history of pure red cell aplasia;
•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, thalassemia of all types, etc.);
•Known hemolysis;
•Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);
•C-reactive protein greater than 30 mg/L within the 4 weeks prior to study drug administration;
•Moderate or significant infection within 2 weeks prior to study drug administration;
•Known coagulation disorder based on clinical context and laboratory \[activated partial thromboplastin time (aPTT) or international normalized ratio (INR)\] results;

Arms & Interventions

Cohorts 4 and 9

Conversion from epoetin alfa to peginesatide with a CF of 0.050: peginesatide dose administered intravenously Q4W for a total of 6 doses. With transition period between epoetin treatment and start of peginesatide treatment.