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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)

Akebia Therapeutics logo

Akebia Therapeutics

Status and phase

Withdrawn
Phase 3

Conditions

Anemia
Dialysis-Dependent Chronic Kidney Disease

Treatments

Drug: Darbepoetin alfa
Drug: Vadadustat

Study type

Interventional

Funder types

Industry

Identifiers

NCT03242967
AKB-6548-CI-0023

Details and patient eligibility

About

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)

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Vadadustat
Experimental group
Description:
Oral tablet
Treatment:
Drug: Vadadustat
Darbepoetin alfa
Active Comparator group
Description:
subcutaneous or intravenous
Treatment:
Drug: Darbepoetin alfa

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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