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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00597584
Other study ID # AFX01-14
Secondary ID 2007-004153-28
Status Completed
Phase Phase 3
First received January 10, 2008
Last updated March 6, 2013
Start date October 2007
Est. completion date January 2010

Study information

Verified date March 2013
Source Affymax
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review BoardBulgaria: Bulgarian Drug AgencyBulgaria: Ethics committeeGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionItaly: The Italian Medicines AgencyItaly: Ethics CommitteePoland: The Central Register of Clinical TrialsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ethics CommitteeRomania: National Medicines AgencyRomania: Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.


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 (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 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 injection, a composite safety endpoint (CSE) was defined for use in prospectively planned analyses which combined cardiovascular safety data from the four Phase 3 peginesatide injection 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.


Recruitment information / eligibility

Status Completed
Enrollment 823
Est. completion date January 2010
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria

1. Participants with chronic renal failure on hemodialysis for = 3 months prior to randomization.

2. On IV epoetin alfa or beta maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.

3. Four consecutive hemoglobin values with a mean = 10.0 and = 12.0 g/dL during the Screening Period.

Exclusion Criteria

1. Females who are pregnant or breast-feeding.

2. Known intolerance to any erythropoiesis stimulating agent or pegylated molecule or to all parenteral iron supplementation products.

3. Known bleeding or coagulation disorder.

4. Known hematologic disease or cause of anemia other than renal disease

5. Poorly controlled hypertension.

6. Evidence of active malignancy within one year prior to randomization.

7. Temporary (untunneled) dialysis access catheter.

8. A scheduled kidney transplant.

9. A scheduled surgery that may be expected to lead to significant blood loss.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
peginesatide
Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study. 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.
Epoetin alfa or Epoetin beta
Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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.

Locations

Country Name City State
Bulgaria Research Facility Burgas
Bulgaria Research Facility Pazardzhik
Bulgaria Research Facility Pleven
Bulgaria Research Facility Plovdiv
Bulgaria Research Facility Plovdiv
Bulgaria Research Facility Rousse
Bulgaria Research Facilities (2) Sofia
Bulgaria Research Facility Sofia
Bulgaria Research Facility Sofia
Bulgaria Research Facility Sofia
Bulgaria Research Facility Varna
Bulgaria Research Facility Veliko Tarnovo
France Research Facility Amiens Cedex 1
France Research Facility Bordeaux
France Research Facility Montpellier Cedex 5
France Research Facility Vannes
Germany Research Facilities (2) Bremen
Germany Research Facility Franfurt
Germany Research Facility Hamburg
Germany Research Facility Kaiserslautern
Italy Research Facility Como
Italy Research Facility Cremona
Italy Research Facility Lecco
Italy Research Facility Modena
Italy Research Facility Prato
Poland Research Facility Ciechanow
Poland Research Facility Katowice
Poland Research Facility Pabianice
Poland Research Facility Wloclawek
Romania Research Facility Bucuresti
Romania Research Facility Bucuresti
Romania Research Facility Iasi
Spain Research Facility Alicante
Spain Research Facility Barcelona
Spain Research Facility Barcelona
Spain Research Facility Barcelona
Spain Research Facility Ciudad Real
Spain Research Facility Madrid
Spain Research Facility Madrid
Spain Research Facility Santander
United Kingdom Research Facility Carshalton
United Kingdom Research Facility London
United Kingdom Research Facility London
United Kingdom Research Facility London
United Kingdom Research Facility Swansea
United States Research Facility Arlington Texas
United States Research Facility Asheville North Carolina
United States Research Facility Bakersfield California
United States Research Facility Bronx New York
United States Research Facility Brookhaven Mississippi
United States Research Facility Brooklyn New York
United States Research Facility Detroit Michigan
United States Research Facility Detroit Michigan
United States Research Facility Erie Pennsylvania
United States Research Facility Fairfax Virginia
United States Research Facility Flossmoor Illinois
United States Research Facility Flushing New York
United States Research Facility Glendale California
United States Research Facility Hines Illinois
United States Research Facility Hot Springs Arkansas
United States Research Facility Houston Texas
United States Research Facility Lauderdale Lakes Florida
United States Research Facility Los Angeles California
United States Research Facility Los Angeles California
United States Research Facility Los Angeles California
United States Research Facility Louisville Kentucky
United States Research Facility McGehee Arkansas
United States Research Facility Miami Florida
United States Research Facility Oklahoma City Oklahoma
United States Research Facility Orangeburg South Carolina
United States Research Facility Philadelphia Pennsylvania
United States Research Facility Phoenix Arizona
United States Research Facility Pine Bluff Arkansas
United States Research Facility Pinecrest Florida
United States Research Facility Providence Rhode Island
United States Research Facility Riverside California
United States Research Facility Rockville Maryland
United States Research Facility San Antonio Texas
United States Research Facility Simi Valley California
United States Research Facility Springfield Massachusetts
United States Research Facility Toledo Ohio
United States Research Facility Westminster Colorado
United States Research Facility Whittier California
United States Research Facility Yuba City California

Sponsors (2)

Lead Sponsor Collaborator
Affymax Takeda

Countries where clinical trial is conducted

United States,  Bulgaria,  France,  Germany,  Italy,  Poland,  Romania,  Spain,  United Kingdom, 

References & Publications (1)

Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A; EMERALD Study Groups. Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Me — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change in Hemoglobin Between Baseline and the Evaluation Period 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. Baseline to Weeks 29-36 No
Secondary Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods Weeks 0 to 36 No
Secondary 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) Weeks 29 to 36 No
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