A Multi-Center, Single Arm Study Evaluating De Novo Once Monthly Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects with Chronic Kidney Disease Not Receiving Dialysis - Darbepoetin Alfa 20060163

Conditions: Treatment of anemia in CKD subjects not receiving dialysis
MedDRA version: 8.1Level: LLTClassification code 10002073Term: Anaemia of chronic disease

Registration Number: EUCTR2006-003173-27-IT

Lead Sponsor: AMGEN S.P.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 155

Inclusion Criteria

8805; 18 years of age Estimated Glomerular Filtration Rate eGFR of 8805; 15 mL/min/1.73 m2 - 8804; 60 mL/min/1.73 m2 MDRD equation The mean of two screening Hb values taken at least 7 days apart must be 11.0 g/dL Serum Ferritin 8805; 100 g/L
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

Upper or lower GI bleeding within the prior 6 months ESA use within 12 weeks before enrollment Uncontrolled hypertension Other hematologic disorders Prior history within 12 weeks before enrollment of events including o Acute myocardial ischemia o Hospitalization for congestive heart failure o Myocardial infarction o Deep vein thrombosis, stroke or transient ischemic attack

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the proportion of subjects achieving a Hemoglobin Hb 8805; 11.0 g/dL at any time-point during the study following de novo QM darbepoetin alfa administration;Secondary Objective: To determine Hb values over the duration of the study To assess the proportion of subjects achieving a mean Hb 8805; 11.0 g/dL during the evaluation period weeks 25-33 To determine QM darbepoetin alfa doses over the duration of the study To assess the safety of darbepoetin alfa administered de novo QM To assess the change in health related quality of life HRQOL scores between baseline, week 17 and end of study;Primary end point(s): Achievement of a Hb 8805; 11.0 g/dL at any time point following de novo QM darbepoetin alfa administration.

Secondary Outcome Measures