Phase 3 N=358 Randomized Double-blind Treatment

Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease

Anemia · Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT00925587 ↗

Enrolled (actual)

358

Serious AEs

29.9%

Results posted

Jun 2014

Primary outcome: Primary: Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33) — 2.157; 1.969 g/dL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: darbepoetin alfa (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)	2.157; 1.969	—
SECONDARY 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.	97.9; 98.1	—
SECONDARY Hb at Baseline	9.17; 9.12	—
SECONDARY Hb at Week 3	9.89; 10.13	—
SECONDARY Hb at Week 5	10.58; 10.28	—
SECONDARY Hb at Week 7	10.90; 10.75	—
SECONDARY Hb at Week 9	11.24; 10.79	—
SECONDARY Hb at Week 11	11.35; 11.17	—
SECONDARY Hb at Week 13	11.56; 11.05	—
SECONDARY Hb at Week 15	11.42; 11.25	—
SECONDARY Hb at Week 17	11.66; 11.12	—
SECONDARY Hb at Week 19	11.50; 11.20	—
SECONDARY Hb at Week 21	11.53; 11.09	—
SECONDARY Hb at Week 23	11.36; 11.08	—
SECONDARY Hb at Week 25	11.34; 10.85	—
SECONDARY Hb at Week 27	11.22; 11.07	—
SECONDARY Hb at Week 29	11.35; 10.90	—
SECONDARY Hb at Week 31	11.31; 11.28	—
SECONDARY Hb at Week 33	11.38; 11.15	—
SECONDARY Darbepoetin Alfa Dose at Week 1	27.65; 27.06	—
SECONDARY Darbepoetin Alfa Dose at Week 3	25.80; 27.06	—
SECONDARY Darbepoetin Alfa Dose at Week 5	24.40; 24.52	—
SECONDARY Darbepoetin Alfa Dose at Week 7	23.42; 24.52	—
SECONDARY Darbepoetin Alfa Dose at Week 9	20.01; 20.59	—
SECONDARY Darbepoetin Alfa Dose at Week 11	18.99; 20.50	—
SECONDARY Darbepoetin Alfa Dose at Week 13	14.67; 19.52	—
SECONDARY Darbepoetin Alfa Dose at Week 15	14.19; 19.15	—
SECONDARY Darbepoetin Alfa Dose at Week 17	12.71; 19.94	—
SECONDARY Darbepoetin Alfa Dose at Week 19	14.52; 19.94	—
SECONDARY Darbepoetin Alfa Dose at Week 21	15.42; 21.59	—
SECONDARY Darbepoetin Alfa Dose at Week 23	14.73; 19.98	—
SECONDARY Darbepoetin Alfa Dose at Week 25	14.55; 20.70	—
SECONDARY Darbepoetin Alfa Dose at Week 27	16.07; 20.79	—
SECONDARY Darbepoetin Alfa Dose at Week 29	15.06; 20.57	—
SECONDARY Darbepoetin Alfa Dose at Week 31	14.48; 19.39	—
SECONDARY Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)	15.21; 19.68	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 3	0.931; 1.000	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 5	0.882; 0.907	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 7	0.845; 0.907	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 9	0.724; 0.761	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 11	0.684; 0.758	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 13	0.531; 0.719	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 15	0.512; 0.707	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 17	0.459; 0.737	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 19	0.525; 0.737	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 21	0.556; 0.797	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 23	0.533; 0.738	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 25	0.526; 0.764	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 27	0.581; 0.768	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 29	0.544; 0.762	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at Week 31	0.525; 0.717	—
SECONDARY 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)	25.95; 29.65	—
SECONDARY Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)	5.0; 5.0	—
SECONDARY Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)	0.550; 0.728	—

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.

Eligibility Criteria

Inclusion Criteria

≥ 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%

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00925587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.