Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis (EMERALD 1)
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| ClinicalTrials.gov Identifier: NCT00597753 |
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Recruitment Status
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Completed
First Posted
: January 18, 2008
Results First Posted
: July 30, 2012
Last Update Posted
: February 12, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Renal Failure Chronic Kidney Disease Anemia | Drug: peginesatide Drug: Epoetin Alfa | Phase 3 |
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 (ESAs) 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.
Eligible participants were randomized in a 2:1 ratio to peginesatide administered once every 4 weeks or to continued treatment with epoetin alfa administered 1-3 times each week, respectively. Total commitment time for this study was 4 weeks of screening followed by a minimum of 52 weeks of study treatment.
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 803 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | AFX01-12: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin Alfa |
| Study Start Date : | September 2007 |
| Actual Primary Completion Date : | July 2009 |
| Actual Study Completion Date : | January 2010 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Peginesatide |
Drug: peginesatide
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Other Names:
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| Active Comparator: Epoetin alfa |
Drug: Epoetin Alfa
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Other Name: Epogen
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- Mean Change in Hemoglobin Between Baseline and the Evaluation Period [ Time Frame: Baseline and Weeks 29-36 ]The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four 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 29 through 36.
- Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods [ Time Frame: Weeks 0 to 36 ]
- Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL) [ Time Frame: Weeks 29 to 36 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization.
- On intravenous epoetin alfa maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.
- Four consecutive hemoglobin values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the screening period
Exclusion Criteria
- Females who are pregnant or breast-feeding.
- Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.
- 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.
- Temporary (untunneled) dialysis access catheter.
- A scheduled kidney transplant
- A scheduled surgery that may be expected to lead to significant blood loss.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597753
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| Study Director: | Vice President, Clinical Development | Affymax |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Affymax |
| ClinicalTrials.gov Identifier: | NCT00597753 History of Changes |
| Other Study ID Numbers: |
AFX01-12 |
| First Posted: | January 18, 2008 Key Record Dates |
| Results First Posted: | July 30, 2012 |
| Last Update Posted: | February 12, 2013 |
| Last Verified: | February 2013 |
Keywords provided by Affymax:
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anemia chronic kidney disease CKD chronic renal failure CRF dialysis erythropoietin EPO erythropoiesis stimulating agent ESA |
Hematide™ hemodialysis hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production |
Additional relevant MeSH terms:
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Anemia Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency Kidney Failure, Chronic |
Hematologic Diseases Urologic Diseases Epoetin Alfa Hematinics |