Trial Outcomes & Findings for Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents (NCT NCT03140722)
NCT ID: NCT03140722
Last Updated: 2021-02-21
Results Overview
TERMINATED
PHASE2
2 participants
Baseline; up to 20 weeks
2021-02-21
Participant Flow
Participant milestones
| Measure |
Epoetin Alfa
Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study.
|
Vadadustat
Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL).
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
Baseline characteristics by cohort
| Measure |
Vadadustat
Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL).
|
Epoetin Alfa
n=2 Participants
Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
—
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; up to 20 weeksPopulation: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; up to 20 weeksPopulation: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; up to 20 weeksPopulation: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 20 weeksPopulation: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 20 weeksPopulation: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 20 weeksPopulation: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 20 weeksPopulation: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 20 weeksPopulation: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 20 weeksPopulation: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: All participants enrolled in the study
Treatment-emergent adverse events were collected in all participants enrolled in the study.
Outcome measures
| Measure |
Vadadustat
Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL).
|
Epoetin Alfa
n=2 Participants
Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Vadadustat
Epoetin Alfa
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER