Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00434330
• Date of registration: 12/02/2007
• Primary sponsor: Affymax
• Public title: Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis
• Scientific 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
• Date of first enrolment: December 2006
• Target sample size: 91
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00434330
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Bulgaria, Romania, United Kingdom

Contacts

• Name: Vice President, Clinical Development
• Affiliation: Affymax, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia

Chronic Kidney Disease

Chronic Renal Failure

Intervention(s)

Drug: peginesatide

Primary Outcome(s)

Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial. [Time Frame: Baseline and Weeks 2-29]

Secondary ID(s)

2006-002815-28

AFX01-07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors