Overview

Peginesatide for Anemia in Chronic Hemodialysis Patients

Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with chronic kidney disease (CKD) who are on hemodialysis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Affymax
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. A highly
effective method of birth control is defined as one that results in a low failure rate
(i.e., less than 1% per year) when used consistently and correctly such as implants,
injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual
abstinence (only acceptable if practiced as a life-style and not acceptable if one who
is sexually active practices abstinence only for the duration of the study) or
vasectomized partner;

- Clinically stable on hemodialysis for ≥6 months prior to study drug administration;

- Urea clearance/volume (Kt/V) ≥ 1.2 within the 4 weeks prior to study drug
administration;

- Epoetin alfa maintenance therapy of ≥ 60 and ≤ 375 U/kg/wk continuously prescribed for
8 weeks prior to study drug administration. In the last 3 weeks prior to study drug
administration, variation in prescribed total weekly dose must be ≤ 25% from the mean
of the last three prescribed total weekly doses;

- Three mid- or end-of-week hemoglobin values of ≥ 10.0 and ≤ 12.5 g/dL in the 3 weeks
prior to study drug administration with ≤ 1.2 g/dL difference between the three
values;

- One serum ferritin level ≥ 100 micrograms per liter (μg/L) or one transferrin
saturation ≥ 20% or one reticulocyte hemoglobin content (CHr) ≥ 29 picograms within 4
weeks prior to study drug administration;

- One serum folate level above the lower limit of normal during the 4 weeks prior to
study drug administration;

- One vitamin B12 level above the lower limit of normal during the 4 weeks prior to
study drug administration;

- Weight ≥ 45 kilograms (kg) within the 4 weeks prior to study drug administration;

- One white blood cell count ≥ 3.0 x 10^9/L within 4 weeks prior to study drug
administration; and

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

Exclusion Criteria:

- Known intolerance to erythropoiesis stimulating agents;

- History of antibodies to erythropoiesis stimulating agents or history of pure red cell
aplasia;

- Known intolerance to parenteral iron supplementation;

- Red blood cell transfusion within 12 weeks prior to study drug administration;

- Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types,
etc.);

- Known hemolysis;

- Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid
arthritis, systemic lupus erythematosus, etc.);

- C-reactive protein greater than 30 mg/L within the 4 weeks prior to study drug
administration;

- Moderate or significant infection within 2 weeks prior to study drug administration;

- Known coagulation disorder based on clinical context and laboratory [activated partial
thromboplastin time (aPTT) or international normalized ratio (INR)] results;

- Temporary (untunneled) dialysis access catheter;

- Uncontrolled or symptomatic secondary hyperparathyroidism;

- Poorly controlled hypertension within the 4 weeks prior to study drug administration,
per the Investigator's clinical judgment (e.g., systolic ≥ 170 mm Hg or diastolic ≥
100 mm Hg on repeat readings);

- Any history of multiple significant drug allergies;

- History of severe or unstable reactive airway disease within the previous 10 years;

- Epileptic seizure in the 6 months prior to screening;

- Chronic congestive heart failure (New York Heart Association Class 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 disease or conditions in the prior 6 months that may, in the Investigator's
opinion, interfere with assessment or follow-up of the patient);

- Evidence of malignancy within the past 5 years (except non-melanoma skin cancer which
is not an exclusion criterion);

- Life expectancy < 12 months;

- Anticipated elective surgery during the study period; and

- Previous exposure to any investigational agent within 6 weeks prior to administration
of study drug or planned receipt during the study period.