| Trial ID: | L0910 |
| Source ID: | NCT03242967
|
| Associated Drug: |
Vadadustat
|
| Title: |
Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
|
| Acronym: |
TRILOGY
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia|Dialysis-Dependent Chronic Kidney Disease
|
| Interventions: |
DRUG: Vadadustat|DRUG: Darbepoetin alfa
|
| Outcome Measures: |
Primary: Mean change in Hb between baseline and the primary evaluation period, Mean change in hemoglobin will be evaluated, Baseline visit, Week 36 | Secondary: Mean change in Hb between baseline and the secondary evaluation period, 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, Hemoglobin values within the target range will be evaluated, Baseline visit, Week 36|Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated, 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Akebia Therapeutics
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-08
|
| Completion Date: |
2018-02-12
|
| Results First Posted: |
|
| Last Update Posted: |
2018-11-05
|
| Locations: |
Research Site, Northridge, California, 91324, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03242967
|
