Trial Outcomes & Findings for Study Evaluating Subjects With Distal Renal Tubular Acidosis (NCT NCT03644706)
NCT ID: NCT03644706
Last Updated: 2026-06-03
Results Overview
Blood bicarbonate levels were measured at the begininning (day 1) and end (day 6) of the withdrawal period, and change in blood bicarbonate levels was calculated as value at day 6 minus value at day 1
TERMINATED
PHASE3
3 participants
day 1, day 6
2026-06-03
Participant Flow
Patients were recruited by the study site teams.
Study was terminated due to Covid-19
Participant milestones
| Measure |
Enrolled to Study
Enrolled, tested and established on ADV7103 in the open label titration and stabilization phase
|
Randomized to ADV7103
Patients continue to receive ADV7103 twice a day at their open label dose over 6 days
|
Randomized to Placebo
Patients receive matched placebo twice a day until they reach a bicarbonate level of 18mEq/L
|
|---|---|---|---|
|
Titration
STARTED
|
3
|
0
|
0
|
|
Titration
COMPLETED
|
3
|
0
|
0
|
|
Titration
NOT COMPLETED
|
0
|
0
|
0
|
|
Randomization/Withdrawal
STARTED
|
0
|
1
|
0
|
|
Randomization/Withdrawal
COMPLETED
|
0
|
1
|
0
|
|
Randomization/Withdrawal
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Subjects With Distal Renal Tubular Acidosis
Baseline characteristics by cohort
| Measure |
All Participants
n=3 Participants
Baseline data collected at enrollment
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: day 1, day 6Population: 3 patients entered the study. Only 1 patient entered period 2 - withdrawal. The small sample size and premature termination of the study limited the assessment of efficacy of ADV7103 versus placebo.
Blood bicarbonate levels were measured at the begininning (day 1) and end (day 6) of the withdrawal period, and change in blood bicarbonate levels was calculated as value at day 6 minus value at day 1
Outcome measures
| Measure |
ADV7103
n=1 Participants
Patients continue to receive ADV7103 twice a day at their open label dose over 6 days
|
Placebo Comparator
Patients receive matched placebo twice a day until they reach a bicarbonate level of 18mEq/L
|
|---|---|---|
|
Change in Blood Bicarbonate Levels During Withdrawal Period
|
27 mmol/l
Standard Deviation NA
SD not calculable for 1 participant
|
—
|
Adverse Events
ADV7103
Placebo Comparator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Adrian Hepner, Acting CMO Advicenne S.A.
Advicenne Pharma
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place