Phase 2
N=22
Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease
Anemia · Chronic Kidney Disease · Chronic Renal Failure · Pure Red Cell Aplasia
Bottom Line
View on ClinicalTrials.gov: NCT00314795 ↗Enrolled (actual)
22
Serious AEs
77.3%
Results posted
Mar 2019
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peginesatide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Percentage of Participants With RBC Transfusions During the 26-week Pre-treatment Period and During 13- and 26-week Intervals During the Study |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation |
22; 17; 3 | — |
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).
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT00314795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.