Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILOGY)

November 1, 2018 updated by: Akebia Therapeutics

Phase 3, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)

This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Northridge, California, United States, 91324
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects ≥18 years of age
  • Receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage kidney disease
  • Currently maintained on ESA therapy
  • Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)

Exclusion Criteria:

  • Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
  • Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
  • Red blood cell transfusion within 4 weeks prior to or during screening
  • Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vadadustat
Oral tablet
Drug: Vadadustat
Oral tablet
Other Names:
  • AKB-6548
ACTIVE_COMPARATOR: Darbepoetin alfa
subcutaneous or intravenous
Drug: Darbepoetin alfa
subcutaneous or intravenous
Other Names:
  • Aranesp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in Hb between baseline and the primary evaluation period
Time Frame: Baseline visit, Week 36
Mean change in hemoglobin will be evaluated
Baseline visit, Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in Hb between baseline and the secondary evaluation period
Time Frame: Baseline visit, Week 52
Mean change in hemoglobin will be evaluated
Baseline visit, Week 52
Proportion of subjects with mean Hb within the target range during the primary evaluation period
Time Frame: Baseline visit, Week 36
Hemoglobin values within the target range will be evaluated
Baseline visit, Week 36
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 52 weeks
Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akebia Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2017

Primary Completion (ACTUAL)

February 12, 2018

Study Completion (ACTUAL)

February 12, 2018

Study Registration Dates

First Submitted

August 4, 2017

First Submitted That Met QC Criteria

August 4, 2017

First Posted (ACTUAL)

August 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKB-6548-CI-0023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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