CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,964 enrolled
Drug / intervention
Daprodustat +3 moredrug
Likely dose
Daprodustat dose based on prior ESA dose, individually titrated; rhEPO converted from prior ESA dose to nearest available study dose, IV, individually titratedAI-extracted
Key inclusion· 6
  • ✓Age 18-99 years
  • ✓On dialysis for >90 days prior to screening, continuing same dialysis mode through randomization
  • ✓Currently on any approved ESA for ≥6 weeks prior to screening and through randomization
  • ✓Hemoglobin 8-12 g/dL at Week -8 screening; at Day 1 randomization: Hgb 8-11 g/dL on minimum ESA dose, or Hgb >11-11.5 g/dL on greater than minimum dose
Key exclusion· 16
  • ✕Planned kidney transplant within 52 weeks of study start
  • ✕Ferritin ≤100 ng/mL at screening or TSAT ≤20%
  • ✕History of bone marrow aplasia or pure red cell aplasia
  • ✕Untreated pernicious anemia, thalassemia major, sickle cell disease, or myelodysplastic syndrome

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

Search/NCT02879305
NCT02879305Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents

GlaxoSmithKline·interventional·Posted Aug 25, 2016·Updated Dec 3, 2021

In Brief

A Phase 3 clinical trial evaluating Daprodustat, rhEPO, and 2 other interventions for Anaemia and Aspergillosis, Allergic Bronchopulmonary. Completed, enrolled 2,964 participants across 462 sites in 35 countries.

Detailed Summary

The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaemia, Aspergillosis, Allergic Bronchopulmonary
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Italy, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 25, 2016
Enrollment StartSep 28, 2016
Primary CompletionNov 9, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.9 years ago

Interventions

Daprodustatdrug

Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.

rhEPOdrug

The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.

Placebodrug

Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).

Iron therapydrug

Participants will receive supplemental iron therapy if ferritin is \<=100 ng/mL or TSAT is \<=20%. The investigator will choose the route of administration and dose of iron.