Overview

This trial has been completed.

Conditions anemia, chronic kidney disease, chronic renal failure, pure red cell aplasia
Treatment peginesatide
Phase phase 2
Sponsor Takeda
Start date April 2006
End date October 2016
Trial size 22 participants
Trial identifier NCT00314795, 2005-004944-30, AFX01-06

Summary

The purpose of this study is to evaluate the ability of peginesatide to increase and maintain increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Peginesatide dose administered subcutaneously once every 4 weeks. The frequency of each injection and the dose may be adjusted based on the participant's hemoglobin response and the ability to maintain a hemoglobin level in the range of 10.0-12.0 g/dL.
peginesatide Omontys

Primary Outcomes

Measure
Proportion of participants who increase and maintain hemoglobin levels (two consecutive values) greater than or equal to the lower limit of the target range in the absence of red blood cell transfusion in the previous 28 days by Week 24.
time frame: 24 weeks

Secondary Outcomes

Measure
Number of red blood cell transfusions during the 26 week pre-treatment period (prior to enrollment) and during 13- and 26 week intervals during the study.
time frame: 26 weeks prior to enrollment to end of study
Time to initial achievement of hemoglobin greater than or equal to the lower limit of the target range in the absence of red blood cell transfusions in the previous 28 days.
time frame: While On Study
Proportion of participants with red blood cell transfusions during the 26 week pre-treatment period (prior to enrollment) and during 13- and 26 week intervals during the study.
time frame: 26 weeks prior to enrollment to end of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Participants who have confirmed antibody-mediated PRCA are potentially eligible for enrollment into this study. - Participants must be ≥ 18 years old at the time of consent. - ESAs must be discontinued for a minimum of 1 month prior to screening. - Participant requires periodic transfusions to maintain hemoglobin. - Hemoglobin < 10 g/dL for at least 2 measurements or participant has received a transfusion within the past 4 weeks to achieve a hemoglobin > 10 g/dL. - Confirmation that an anti-erythropoietin antibody sample was obtained for analysis by the central reference laboratory within 1 month prior to baseline. - Participants can either be participants with chronic kidney disease not yet requiring renal replacement therapy (participants not on dialysis), those on regular hemodialysis or peritoneal dialysis, or following a renal transplant. - Participants may or may not have previously been treated with immunosuppressive therapy. - Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening. - Written informed consent must be obtained. Exclusion Criteria: - Participants already successfully on another erythropoietic agent. - Abnormal bone marrow findings consistent with the diagnosis of myelodysplasia, a myeloproliferative disorder, hematologic malignancy or evidence of metastatic infiltration. - Poorly controlled hypertension. - Previous exposure to any investigational agent within 4 weeks prior to administration of study drug or planned receipt during the study period. - High likelihood of early withdrawal or interruption of the study. - Participants who refuse to give informed consent. - Women who are pregnant, lactating or not using a medically approved birth control. - Life expectancy < 12 months.

Additional Information

Official title An Open-Label Study to Investigate the Efficacy and Safety of Peginesatide in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease
Description This is an open-label treatment study; all patients enrolled into the study will receive AF37702 Injection. Hematologic data prior to treatment with AF37702 Injection will be compared to values obtained during treatment with AF37702 Injection (see Section 6.2). CKD patients with documented antibody-mediated PRCA, hemoglobin level < 10 g/dL (without ESA therapy) or require transfusions to maintain this hemoglobin level, and who meet the eligibility criteria will be enrolled. It is anticipated that up to 40 patients will be enrolled in the trial. The first group of 5 patients will receive a starting dose of 0.05 mg/kg, administered every 4 weeks (for this study, 1 month is defined as 4 weeks). Based on the assessment of the dose response in this initial group of 5 patients, it is recommended the starting dose in subsequent patients be increased to 0.075 mg/kg. The individual dose of AF37702 Injection will be modified based on hemoglobin levels. Dose adjustments will be made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL (see Section 5.4.1). The frequency of dosing may be decreased and dosing ultimately discontinued if Hgb is maintained within the target range. Due to the lack of treatment options in this population, more frequent dosing is justified in cases of a suboptimal response. If the Investigator determines that a patient has a suboptimal response despite dose increases, the frequency of injections may be increased up to once every other week, but the total dose may not exceed 0.35 mg/kg every 4 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Takeda.