Back to resultsEfficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease
Primary Purpose
Anemia, Chronic Kidney Disease, Chronic Renal Failure
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Peginesatide
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Drug Therapy, 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
Eligibility Criteria
Inclusion Criteria: Participants who have confirmed antibody-mediated Pure red cell aplasia (PRCA) are potentially eligible for enrollment into this study. Participants must be ≥ 18 years old at the time of consent. Erythropoiesis stimulating agents (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.
Sites / Locations
- Research Facility
- Research Facility
- Research Facility
- Research Facility
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peginesatide
Arm Description
Peginesatide 0.05 mg/kg injection, subcutaneously as a starting dose followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 6 months. Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Experienced 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
Percentage of participants who experienced increase and maintain hemoglobin levels (two consecutive values) greater than or equal to the lower limit (11 g/dL) in the absence of red blood cell transfusion in the previous 28 days by week 24 were reported.
Secondary Outcome Measures
Number of Red Blood Cells (RBCs) Transfusions During the 26 Weeks Pre-treatment Period (Prior to Enrollment) and During 13- and 26 Weeks Intervals During the Study
Percentage of Participants With RBC Transfusions During the 26-week Pre-treatment Period and During 13- and 26-week Intervals During the Study
Time to Initial Achievement of Hemoglobin (Hgb) 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
The time between first dose administered and the initial achievement of a Hgb increase ≥11 g/dL for two consecutive visits was calculated for each participant as the number of days between the first dose administration date and the earlier of (1) the study termination date [i.e. censor date] and (2) the first date of an Hgb increase ≥ 11 g/dL for two consecutive visits without whole blood or RBC transfusion during the previous 28 days. Time to initial Hgb increase ≥ 11 g/dL will be calculated for each participant as the minimum of censor date and increase date minus the first dose date plus 1.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00314795
Brief Title
Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease
Official Title
An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 6, 2006 (Actual)
Primary Completion Date
October 24, 2016 (Actual)
Study Completion Date
October 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the ability of peginesatide (AF37702) 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).
Detailed Description
The drug being tested in this study was peginesatide. Peginesatide injection was tested to investigate the efficacy and safety in the treatment of anemia caused by antibody-mediated pure red cell aplasia in participants with chronic kidney disease.
The study enrolled 22 patients. All the participants enrolled into the study received:
• Peginesatide 0.5 mg/kg subcutaneous (SC) injection
The participants received a starting dose of 0.05 mg/kg (every 4 weeks) followed by 0.1 mg/kg dose, based on the assessment of the dose response in the initial group of 5 participants. The frequency of each injection and the dose 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.
This multi-center trial was conducted in Europe. The overall time to participate in this study was 10 years and 7 months approximately. Participants made multiple visits to the clinic until the projected end of treatment period, which was 31-Oct-2016.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Kidney Disease, Chronic Renal Failure, Pure Red Cell Aplasia
Keywords
Drug Therapy, 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peginesatide
Arm Type
Experimental
Arm Description
Peginesatide 0.05 mg/kg injection, subcutaneously as a starting dose followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 6 months.
Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL.
Intervention Type
Drug
Intervention Name(s)
Peginesatide
Other Intervention Name(s)
Omontys, Hematide, AF37702
Intervention Description
Peginesatide injection
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced 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
Description
Percentage of participants who experienced increase and maintain hemoglobin levels (two consecutive values) greater than or equal to the lower limit (11 g/dL) in the absence of red blood cell transfusion in the previous 28 days by week 24 were reported.
Time Frame
Up to Week 24
Secondary Outcome Measure Information:
Title
Number of Red Blood Cells (RBCs) Transfusions During the 26 Weeks Pre-treatment Period (Prior to Enrollment) and During 13- and 26 Weeks Intervals During the Study
Time Frame
26 weeks prior to enrollment up to end of study (up to 60 months)
Title
Percentage of Participants With RBC Transfusions During the 26-week Pre-treatment Period and During 13- and 26-week Intervals During the Study
Time Frame
26 weeks prior to enrollment up to end of study (up to 60 months)
Title
Time to Initial Achievement of Hemoglobin (Hgb) 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
Description
The time between first dose administered and the initial achievement of a Hgb increase ≥11 g/dL for two consecutive visits was calculated for each participant as the number of days between the first dose administration date and the earlier of (1) the study termination date [i.e. censor date] and (2) the first date of an Hgb increase ≥ 11 g/dL for two consecutive visits without whole blood or RBC transfusion during the previous 28 days. Time to initial Hgb increase ≥ 11 g/dL will be calculated for each participant as the minimum of censor date and increase date minus the first dose date plus 1.
Time Frame
Up to 60 months
Title
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation
Description
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame
From signing of informed consent form up to Month 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who have confirmed antibody-mediated Pure red cell aplasia (PRCA) are potentially eligible for enrollment into this study.
Participants must be ≥ 18 years old at the time of consent.
Erythropoiesis stimulating agents (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Research Facility
City
Paris
Country
France
Facility Name
Research Facility
City
Erlangen
Country
Germany
Facility Name
Research Facility
City
Derby
Country
United Kingdom
Facility Name
Research Facility
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19890127
Citation
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.
Results Reference
result
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Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease
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