MedTrace Logo

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

NCT02876835 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3872

Last updated 2024-04-02

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Anaemia

Interventions

DRUG

Daprodustat

The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.

DRUG

Darbepoetin alfa

The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.

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
2016-09-27
Primary Completion
2021-04-19
Completion
2021-04-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom
  • Vietnam

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 NCT02876835 on ClinicalTrials.gov