Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis (PEARL 2)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Renal Failure Chronic Kidney Disease Anemia |
Drug: peginesatide Drug: Darbepoetin alfa |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | AFX01-13: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment |
- Mean Change in Hemoglobin Between Baseline and the Evaluation Period [ Time Frame: Baseline and Weeks 25-36 ] [ Designated as safety issue: No ]The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.
- Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods [ Time Frame: Weeks 0 to 36 ] [ Designated as safety issue: No ]
- Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods [ Time Frame: Weeks 0 to 36 ] [ Designated as safety issue: No ]A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.
| Enrollment: | 493 |
| Study Start Date: | November 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Peginesatide 0.025 mg/kg |
Drug: peginesatide
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
Other Names:
|
| Experimental: Peginesatide 0.04 mg/kg |
Drug: peginesatide
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Other Names:
|
| Active Comparator: Darbepoetin alfa |
Drug: Darbepoetin alfa
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Other Name: Aranesp
|
Detailed Description:
Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure.
Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia in patients with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.
Study participants received doses of peginesatide administered once every 4 weeks or darbepoetin alfa administered once every 2 weeks. Total commitment time for this study was a 4 week screening period followed by a minimum of 52 weeks of study treatment. Eligible participants were randomized in equal proportions to two peginesatide treatment regimens and one control, darbepoetin alfa, treatment regimen.
To evaluate the cardiovascular safety of peginesatide, a cardiovascular composite safety endpoint (CSE) was defined for use in prospectively planned analyses which combined cardiovascular safety data from the four Phase 3 peginesatide studies (NCT00598273, NCT00597753, NCT00598442, and NCT00597584). The CSE consisted of six events: death, stroke, myocardial infarction, and serious adverse events of congestive heart failure, unstable angina, and arrhythmia. An independent Event Review Committee (ERC) was used to provide blinded adjudication of potential CSE events.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chronic renal failure with an estimated glomerular filtration rate < 60 milliliters per minute per 1.73 m^2 and not expected to begin dialysis for at least 12 weeks.
- Two consecutive hemoglobin values ≥ 8.0 g/dL and < 11.0 g/dL within 4 weeks prior to randomization.
Exclusion Criteria:
- Females who are pregnant or breast-feeding.
- Treatment with an ESA in the 12 weeks prior to randomization.
- Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
- Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
- Known bleeding or coagulation disorder.
- Known hematologic disease or cause of anemia other than renal disease.
- Poorly controlled hypertension.
- Evidence of active malignancy within one year prior to randomization
- A scheduled kidney transplant.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00598442
Show 64 Study Locations
| Study Director: | Vice President, Clinical Development | Affymax |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Affymax |
| ClinicalTrials.gov Identifier: | NCT00598442 History of Changes |
| Other Study ID Numbers: | AFX01-13 2007-004146-32 |
| Study First Received: | January 10, 2008 |
| Results First Received: | April 26, 2012 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Bulgaria: Bulgarian Drug Agency Bulgaria: Ethics committee Czech Republic: State Institute for Drug Control Czech Republic: Ethics Committee Germany: Federal Institute for Drugs and Medical Devices Germany: Ethics Commission Hungary: National Institute of Pharmacy Hungary: Scientific and Medical Research Council Ethics Committee Italy: The Italian Medicines Agency Italy: Ethics Committee Poland: The Central Register of Clinical Trials Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland: Ethics Committee Romania: National Medicines Agency Romania: Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee |
Keywords provided by Affymax:
|
anemia chronic kidney disease CKD chronic renal failure CRF erythropoietin EPO erythropoiesis stimulating agent ESA |
Hematide™ hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production |
Additional relevant MeSH terms:
|
Anemia Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency Kidney Failure, Chronic |
Hematologic Diseases Urologic Diseases Darbepoetin alfa Hematinics |
ClinicalTrials.gov processed this record on September 23, 2016