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NCT01750190 · ClinicalTrials.gov registry record · Phase 3

A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

A Phase 3 study, sponsored by Kyntra Bio.

Completed
Registry status
Phase 3
Development phase
922
Enrollment target

NCT01750190: Completed Phase 3 study, sponsored by Kyntra Bio.

NCT01750190 is a Phase 3 study that has completed, run by Kyntra Bio. The registered enrollment target is 922 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01750190, a Phase 3 study, has completed, sponsored by Kyntra Bio.

COMPLETED
Registry status
Phase 3
Development phase
922 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

Primary Outcome

The change in Hb from baseline to the average level during the evaluation period (defined as Week 28 until Week 52) is reported. Hb values under the influence of a rescue therapy were not censored. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb

Interventions

  • DRUG Placebo
  • DRUG Roxadustat

Trial Details

FieldValue
Enrollment Target 922 participants
Start Date 2012-11-05
Est. Completion 2018-09-24
Phase Phase 3
Kyntra Bio

30 total trials

What the finished NCT01750190 record still lists

NCT01750190 is an interventional study that assigns participants to a tested intervention. The registered 922 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher).

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

NCT01750190 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01750190 about?

NCT01750190 is a clinical study titled "A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis". The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

What is the current status of trial NCT01750190?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 922 participants. The study started on 2012-11-05. Estimated completion is 2018-09-24.

What interventions are being tested in trial NCT01750190?

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

Who is sponsoring clinical trial NCT01750190?

This trial is sponsored by Kyntra Bio, which has 30 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01750190's enrollment target sits among peer trials

922 344th of 2000 higher than 1,656 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 NCT01750190, the US trial registry maintained by the National Library of Medicine. NCT01750190 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.