Efficacy and Safety of Peginesatide in the Treatment of Anemia in Patients With Chronic Kidney Disease

Study Description

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Brief 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).

Condition or disease	Intervention/treatment	Phase
Anemia; Chronic Kidney Disease; Chronic Renal Failure; Pure Red Cell Aplasia	Drug: peginesatide	Phase 2

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	22 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	April 2006
Actual Primary Completion Date :	October 2016
Actual Study Completion Date :	October 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Peginesatide; 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.	Drug: peginesatide; Other Names: Omontys; Hematide; AF37702 Injection

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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 ]
2. 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 ]
3. 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

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Research Facility
Paris, France
Germany
Research Facility
Erlangen, Germany
United Kingdom
Research Facility
Derby, United Kingdom
Research Facility
London, United Kingdom

Sponsors and Collaborators

Takeda

Investigators

Study Director:	Medical Director	Takeda

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Macdougall IC, Rossert J, Casadevall N, Stead RB, Duliege AM, Froissart M, Eckardt KU. A peptide-based erythropoietin-receptor agonist for pure red-cell aplasia. N Engl J Med. 2009 Nov 5;361(19):1848-55. doi: 10.1056/NEJMoa074037.

Responsible Party:	Takeda
ClinicalTrials.gov Identifier:	NCT00314795 History of Changes
Other Study ID Numbers:	AFX01-06; 2005-004944-30 ( EudraCT Number )
First Posted:	April 17, 2006
Last Update Posted:	November 30, 2016
Last Verified:	November 2016

Keywords provided by Takeda:

pure red cell aplasia; PRCA; chronic kidney disease; CKD; chronic renal failure; CRF; anemia; erythropoietin	EPO; erythropoiesis stimulating agent; ESA; hemoglobin; Hb; Hgb; red blood cell; red blood cell production

Additional relevant MeSH terms:

Anemia; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency	Kidney Failure, Chronic; Red-Cell Aplasia, Pure; Hematologic Diseases; Urologic Diseases