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Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis

Information source: Affymax
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia; Chronic Kidney Disease; Chronic Renal Failure

Intervention: peginesatide (Drug); peginesatide (Drug); peginesatide (Drug); peginesatide (Drug); peginesatide (Drug); peginesatide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Affymax

Official(s) and/or principal investigator(s):
Vice President, Clinical Development, Study Director, Affiliation: Affymax, Inc.

Summary

The purpose of this study was to determine the dose ranges of peginesatide administered intravenously or subcutaneously that maintained hemoglobin in participants on dialysis whose hemoglobin values were stable on epoetin (alfa or beta).

Clinical Details

Official title: A Phase 2, Open-Label, Multi-Center, Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin

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

Primary outcome: Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.

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 subjects with chronic kidney disease, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia associated 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. Six dose cohorts of 15 participants each were evaluated in this study. Participants received peginesatide injection once every 4 weeks administered intravenously or subcutaneously for a total of 7 doses.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participant is informed of the investigational nature of this study and has given

written, witnessed informed consent in accordance with institutional, local, and national guidelines

- Males or females ≥ 18 years of age. Pre-menopausal females (with the exception of

those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study start, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug

- Clinically stable on hemodialysis for ≥ 3 months prior to study start

- Epoetin (alfa or beta) maintenance therapy, ≥ 50 and ≤ 200 Units/kg/week, at the same

dosing frequency, continuously prescribed for 8 weeks prior to study start

- Three mid- or end-of-week hemoglobin values of ≥ 10. 0 and ≤ 12. 5 grams per deciliter

(g/dL) in the 4 weeks prior to study start, with ≤ 1. 2 g/dL difference between any of the three values

- One transferrin saturation (TSAT) > 20% within 4 weeks prior to study start

- One ferritin level ≥ 100 ng/mL within 4 weeks prior to study start

- One serum or red cell folate level ≥ lower limit of normal during the 4 weeks prior

to study start

- One vitamin B12 level ≥ lower limit of normal during the 4 weeks prior to study start

- One C-reactive protein (CRP) level ≤ 30 mg/L within 4 weeks prior to study start

- Urea clearance/volume (Kt/V) ≥ 1. 2 within 4 weeks prior to study start

- One white blood cell count (WBC) ≥ 3. 0 x 10^9/L within 4 weeks prior to study start

- One platelet count ≥ 100 x 10^9/L and ≤ 500 x 10^9/L within 4 weeks prior to study

start Exclusion Criteria:

- Pregnant or breast-feeding participants

- Known intolerance to any erythropoiesis stimulating agent, parenteral iron

supplementation or pegylated molecules

- History of antibodies to any erythropoiesis stimulating agent or history of pure red

cell aplasia (PRCA)

- Known bleeding or coagulation disorder

- Known hematologic disease (e. g., homozygous sickle-cell disease, thalassemia of all

types, multiple myeloma, hemolytic anemia)

- Uncontrolled or symptomatic inflammatory disease (e. g., rheumatoid arthritis,

systemic lupus erythematosus, etc.)

- Known history of seizure disorder or received anti-epileptic medication within the

previous 6 months

- Uncontrolled or symptomatic secondary hyperparathyroidism, per Investigator's

clinical judgment

- Poorly controlled hypertension within 4 weeks prior to study start, per

Investigator's clinical judgment

- Chronic congestive heart failure of New York Heart Association class III or IV

- High likelihood of early withdrawal or interruption of the study (e. g., myocardial

infarction, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric, or neurological abnormalities, liver disease including active hepatitis B or C, active HIV disease, or any other clinically significant medical diseases or conditions in the prior 6 months that may, in the Investigator's opinion, interfere with safety, assessment, or follow-up of the participant)

- Evidence of malignancy within the past 5 years (except non-melanoma skin cancer

which is not an exclusion criterion)

- Life expectancy < 12 months

- Temporary (untunneled) dialysis access catheter

- Anticipated elective surgery during the study period, that may be expected to lead to

significant blood loss, including vascular access surgery such as an arteriovenous fistula or graft, or a scheduled kidney transplant

- Red blood cell or whole blood transfusion within 12 weeks prior to study start

- Received antibiotics for systemic infection within 2 weeks prior to study start

- Previous exposure to any investigational agent within 6 weeks prior to study start,

or planned receipt of an investigational agent, other than as specified by this protocol, during the study period

Locations and Contacts

Research Facility, Burgas 8000, Bulgaria

Research Facility, Pleven 5800, Bulgaria

Research Facility, Plovdiv 4003, Bulgaria

Research Facility, Rousse 7002, Bulgaria

Research Facility, Sofia 1527, Bulgaria

Research Facility, Sofia 1606, Bulgaria

Research Facility, Sofia 1709, Bulgaria

Research Facility, Varna 9010, Bulgaria

Research Facility, Veliko Tarnovo 5000, Bulgaria

Research Facility, Arad 310017, Romania

Research Facility, Bacau 600114, Romania

Research Facility, Bucuresti, Romania

Research Facility, Iasi 700503, Romania

Research Facility, Timisoara 300736, Romania

Research Facility, London SE5 9RS, United Kingdom

Additional Information

Starting date: December 2006
Last updated: June 22, 2012

Page last updated: August 23, 2015

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