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NCT02174731 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
2,133
Enrollment target

NCT02174731: Completed Phase 3 study, sponsored by AstraZeneca.

NCT02174731 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 2,133 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (176% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02174731, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
2,133 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.

Primary Outcome

Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation Analysis of Covariance (ANCOVA). Baseline Hb was used as a covariate and treatment group, cardiovascular (CV) history, geographic region and dialysis duration as fixed effects. The adjusted least squares (LS) mean

Interventions

  • DRUG Epoetin alfa
  • DRUG Roxadustat

Trial Details

FieldValue
Enrollment Target 2,133 participants
Start Date 2014-07-01
Est. Completion 2018-09-26
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT02174731 record still lists

NCT02174731 is an interventional study that assigns participants to a tested intervention. Its 2,133 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 (176% higher).

The record links to 0 conditions, and to 2 interventions - of which Epoetin alfa is the first listed.

NCT02174731 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02174731 about?

NCT02174731 is a clinical study titled "Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.". The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.

What is the current status of trial NCT02174731?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,133 participants. The study started on 2014-07-01. Estimated completion is 2018-09-26.

What interventions are being tested in trial NCT02174731?

The interventions under investigation include: Epoetin alfa (DRUG), Roxadustat (DRUG).

Who is sponsoring clinical trial NCT02174731?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02174731's enrollment target sits among peer trials

2,133 97th of 2000 higher than 1,904 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 NCT02174731, the US trial registry maintained by the National Library of Medicine. NCT02174731 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.