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Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)

NCT02879305 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2964

Last updated 2021-12-03

Study results available
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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.

Conditions

  • Anaemia
  • Aspergillosis, Allergic Bronchopulmonary

Interventions

DRUG

Daprodustat

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

DRUG

rhEPO

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.

DRUG

Placebo

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

DRUG

Iron therapy

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-28
Primary Completion
2020-11-09
Completion
2020-11-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • 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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02879305 on ClinicalTrials.gov