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NCT01381094 · ClinicalTrials.gov registry record · Phase 2

42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia

A Phase 2 study, sponsored by Akebia Therapeutics.

Completed
Registry status
Phase 2
Development phase
93
Enrollment target

NCT01381094 is a Phase 2 study that has completed, run by Akebia Therapeutics. The registered enrollment target is 93 participants.

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The verdict

NCT01381094, a Phase 2 study, has completed, sponsored by Akebia Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
93 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.

Interventions

  • DRUG Placebo
  • DRUG AKB-6548

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2011-06-15
Est. Completion 2012-02-16
Phase Phase 2

Sponsor

Akebia Therapeutics

24 total trials

What the Registry Record Tells You About NCT01381094

The ClinicalTrials.gov registry entry for NCT01381094 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akebia Therapeutics, which has 24 total studies on file at ClinicalTrials.gov.

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

NCT01381094 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01381094 about?

NCT01381094 is a clinical study titled "42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia". The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.

What is the current status of trial NCT01381094?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2011-06-15. Estimated completion is 2012-02-16.

What interventions are being tested in trial NCT01381094?

The interventions under investigation include: Placebo (DRUG), AKB-6548 (DRUG).

Who is sponsoring clinical trial NCT01381094?

This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.