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NCT02876835 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
3,872
Enrollment target

NCT02876835: Completed Phase 3 study, sponsored by GlaxoSmithKline.

NCT02876835 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,872 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (402% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02876835, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
3,872 participants
Enrollment target

Study 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.

Primary Outcome

Time to MACE defined as time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction \[MI\] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, current erythropoiesis-stimulating agents (ESA) use at randomization and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 p

Interventions

  • DRUG Placebo
  • DRUG Darbepoetin alfa
  • DRUG Daprodustat
  • DRUG Iron Therapy

Trial Details

FieldValue
Enrollment Target 3,872 participants
Start Date 2016-09-27
Est. Completion 2021-04-19
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the finished NCT02876835 record still lists

NCT02876835 is an interventional study that assigns participants to a tested intervention. Its 3,872 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (402% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT02876835 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02876835 about?

NCT02876835 is a clinical study titled "Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)". 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.

What is the current status of trial NCT02876835?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,872 participants. The study started on 2016-09-27. Estimated completion is 2021-04-19.

What interventions are being tested in trial NCT02876835?

The interventions under investigation include: Placebo (DRUG), Darbepoetin alfa (DRUG), Daprodustat (DRUG), Iron Therapy (DRUG).

Who is sponsoring clinical trial NCT02876835?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02876835's enrollment target sits among peer trials

3,872 65th of 2000 higher than 1,936 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02876835, the US trial registry maintained by the National Library of Medicine. NCT02876835 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.