Study Evaluating Once Monthly Darbepoetin Alfa Dosing for the Correction of Anemia in Non-dialysis Patients With Chronic Kidney Disease
- Conditions
- Anemia in subjects with chronic kidney disease not receiving dialysisMedDRA version: 14.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 14.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2006-003173-27-BE
- Lead Sponsor
- Amgen Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 334
= 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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 214
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 Main Objective: To determine whether the efficacy of once monthly (QM) darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) darbepoetin alfa for the correction of anemia in subjects with CKD not receiving dialysis.;Secondary Objective: To evaluate whether the safety and tolerability of QM darbepoetin alfa is similar to that of Q2W darbepoetin alfa for subjects with CKD not receiving dialysis.;Primary end point(s): Hb change between baseline and the evaluation period (weeks 29-33)<br><br>;Timepoint(s) of evaluation of this end point: Baseline and Weeks 29 - 33
- Secondary Outcome Measures
Name Time Method