Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
- Registration Number
- NCT00925587
- Lead Sponsor
- Amgen
- Brief Summary
The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 358
- ≥ 18 years of age
- Diagnosis of chronic kidney disease with eGFR of 15-59 mL/min/1.73 m2 (MDRD equation)
- Two consecutive screening Hb values taken at least 7 days apart must each be <10.0 g/dL
- TSAT ≥ 15%
- Upper or lower GI bleeding within 6 months before enrolment
- ESA use within 12 weeks before enrolment
- Uncontrolled hypertension
- Systemic haematologic disorders
- Prior history within 12 weeks before enrollment of events including: Acute myocardial ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis, thromboembolism.
- Grand mal seizure within 6 months prior to enrolment
- Evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5 years prior to enrolment.
- Red blood cell transfusion within 12 weeks prior to enrolment
- Androgen therapy within 8 weeks prior to enrolment
- Pregnancy or breast feeding, or inadequate contraception
- Currently receiving immunosuppressive therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QM darbepoetin alfa QM administration of darbepoetin alfa Q2W darbepoetin alfa Q2W administration of darbepoetin alfa.
- Primary Outcome Measures
Name Time Method Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33) Baseline Week 33 The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.
- Secondary Outcome Measures
Name Time Method Hb at Baseline Baseline Hb at Week 3 Week 3 Hb at Week 5 Week 5 Hb at Week 7 Week 7 Hb at Week 9 Week 9 Hb at Week 11 Week 11 Hb at Week 13 Week 13 Hb at Week 15 Week 15 Hb at Week 17 Week 17 Hb at Week 19 Week 19 Hb at Week 21 Week 21 Hb at Week 23 Week 23 Hb at Week 25 Week 25 Hb at Week 27 Week 27 Hb at Week 29 Week 29 Hb at Week 31 Week 31 Hb at Week 33 Week 33 Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration. Baseline to Week 33 Darbepoetin Alfa Dose at Week 1 Week 1 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 3 Week 3 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 5 Week 5 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 7 Week 7 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 9 Week 9 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 11 Week 11 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 13 Week 13 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 15 Week 15 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 17 Week 17 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 19 Week 19 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 21 Week 21 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 23 Week 23 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 25 Week 25 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 27 Week 27 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 29 Week 29 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 31 Week 31 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33) Weeks 29-33 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 3 Week 3 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 5 Week 5 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 7 Week 7 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 9 Week 9 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 11 Week 11 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 13 Week 13 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 15 Week 15 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 17 Week 17 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 19 Week 19 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 21 Week 21 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 23 Week 23 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 25 Week 25 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 27 Week 27 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 29 Week 29 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 31 Week 31 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33) Weeks 1-33 Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33) Weeks 1-33 Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33) Evaluation Period Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Trial Locations
- Locations (1)
Research Site
🇬🇧Wolverhampton, United Kingdom