CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 312 enrolled
Drug / intervention
Daprodustat +2 moredrug
Likely dose
Daprodustat 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03029208
NCT03029208Phase 3Completed
CompareCT.gov

A 52-week Open-label (Sponsor-blind), Randomized, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy and Safety of Daprodustat Compared to Recombinant Human Erythropoietin in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Initiating Dialysis

GlaxoSmithKline·interventional·Posted Jan 24, 2017·Updated Oct 20, 2021

In Brief

A Phase 3 clinical trial evaluating Daprodustat, Darbepoetin alfa, and 1 other intervention for Anaemia. Completed, enrolled 312 participants across 111 sites in 15 countries.

Detailed Summary

The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaemia
CountriesArgentina, Australia, Canada, Germany, India, Italy, Malaysia, Mexico, Poland, Russia, South Africa, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 24, 2017
Enrollment StartMay 11, 2017
Primary CompletionSep 24, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.4 years ago

Interventions

Daprodustatdrug

Daprodustat will be supplied as film coated tablets for oral administration containing 1, 2, 4, 6, 8, or 10 mg of daprodustat. Doses of 12, 16, and 24 mg of daprodustat will be provided using multiples of these tablet strengths.

Darbepoetin alfadrug

Darbepoetin alfa will be supplied as prefilled syringes (PFS) for SC/IV injection available in strengths: 20, 30, 40, 60, 80, 100 and 150 mcg.

Iron therapydrug

Iron therapy will be administered if ferritin is \<=100 ng/mL and/or TSAT is \<=20%.