A Multicenter, Randomized, Double-blind Study Comparing De Novo OnceMonthly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction ofAnemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 540

Inclusion Criteria

= 18 years of age
Diagnosis of chronic kidney disease with eGFR of 15 - 59 mL/min/1.73 m2
measured by the following modified Modification of Diet and Renal Disease
equation (Levey, 2006):
eGFR = 175 x [standardized serum creatinine µmol/L x .0113]-1.154 x [Age in
years] 0.203 x [0.742 if subject is female] x [1.212 if subject is black]
Clinically stable, in the judgment of the investigator
Two consecutive screening Hb values taken at least 7 days apart, and prior to
randomization, must each be < 10.0 g/dL
Adequate iron stores (TSAT = 15%)
Subject is available for protocol-required study visits, to the best of the
subject’s and investigator’s knowledge
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Scheduled to receive a kidney transplant
ESA use within 12 weeks before enrollment
Uncontrolled hypertension defined as diastolic BP > 100 mm Hg or systolic BP
> 170 mm Hg
Acute myocardial ischemia, unstable angina (as determined by the
investigator), myocardial infarction; hospitalization for congestive heart failure;
stroke or transient ischemic attack; limb ischemia, deep vein thrombosis,
thromboembolism, within 12 weeks before enrollment
Major surgery within 12 weeks before enrollment (excluding vascular access
surgery).
Currently receiving antibiotic therapy for systemic infection.
Known positive HIV antibody or positive hepatitis B surface antigen
Evidence of, or received chemotherapy or radiation therapy for, a
malignancy within 5 years prior to enrollment, with the following
exceptions: localized basal or squamous cell carcinoma of the skin,
cervical intraepithelial neoplasia.
Red blood cell (RBC) transfusions within 12 weeks before enrollment
Androgen therapy within 8 weeks before enrollment
Systemic hematological disease (eg, sickle cell anemia, myelodysplastic
syndromes, hematologic malignancy; myeloma; hemolytic anemia)
Any disorder that may impact (in the judgment of the investigator) the ability to
give informed consent for participation in this study
Subject of child-bearing potential is evidently pregnant (ie, positive HCG
test) or is breast feeding. Subject is not using adequate contraceptive
precautions
Treatment with an investigational agent or device within 30 days before
enrollment or scheduled to receive an investigational agent other than those
specified by this protocol during the course of this study
Subject has known sensitivity to any of the products to be administered
during dosing, including the presence of known neutralizing antierythropoietic
protein antibodies
Grand mal seizure within 6 months before enrollment
Upper or lower GI bleeding within 6 months before enrollment
Currently receiving immunosuppressive therapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Study Evaluating Once Monthly Darbepoetin Alfa Dosing for the Correction of Anemia in Non-dialysis Patients With Chronic Kidney Disease

Amgen Ltd

Updated 8/28/2012