Trial Outcomes & Findings for Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria (NCT NCT02289755)
NCT ID: NCT02289755
Last Updated: 2019-06-05
Results Overview
Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
7 days
Results posted on
2019-06-05
Participant Flow
Subjects (N = 16) were recruited from 3 centers in the United States between August 2014 and December 2014.
History of ≥1 calcium oxalate kidney stone within the last 2 years, secondary hyperoxaluria and a mean urinary oxalate of ≥36 mg/day
Participant milestones
| Measure |
ALLN-177
ALLN-177 (5 capsules; 7,500 units/meal) by mouth 3 times a day with main meals for 4 consecutive days.
|
|---|---|
|
Baseline Period [No Treatment, 3 Days]
STARTED
|
16
|
|
Baseline Period [No Treatment, 3 Days]
COMPLETED
|
16
|
|
Baseline Period [No Treatment, 3 Days]
NOT COMPLETED
|
0
|
|
ALLN-177 Treatment Period [4 Days]
STARTED
|
16
|
|
ALLN-177 Treatment Period [4 Days]
COMPLETED
|
16
|
|
ALLN-177 Treatment Period [4 Days]
NOT COMPLETED
|
0
|
|
Follow up Period [4 Days]
STARTED
|
16
|
|
Follow up Period [4 Days]
COMPLETED
|
16
|
|
Follow up Period [4 Days]
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
Baseline characteristics by cohort
| Measure |
ALLN-177
n=16 Participants
ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
58.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
|
Glomerular Filtration Rate (GFR)
|
85.1 ml/min/1.73 m^2
n=5 Participants
|
|
Concomitant medications
Potassium citrate
|
5 participants
n=5 Participants
|
|
Concomitant medications
Chlorthalidone
|
2 participants
n=5 Participants
|
|
Concomitant medications
Hydrochlorothiazide
|
1 participants
n=5 Participants
|
|
Concomitant medications
Calcium
|
5 participants
n=5 Participants
|
|
24-hour Urinary Oxalate
|
77.65 mg/day
STANDARD_DEVIATION 55.87 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: All Participants (N=16) completed treatment and were included in the analysis population.
Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).
Outcome measures
| Measure |
ALLN-177
n=16 Participants
ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
|
|---|---|
|
Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion
|
-13.92 mg/day
Standard Deviation 18.37
|
SECONDARY outcome
Timeframe: 7 daysPopulation: All Participants (N=16) were included in the analysis.
Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100%
Outcome measures
| Measure |
ALLN-177
n=16 Participants
ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
|
|---|---|
|
Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion
|
-13.28 percentage change
Standard Deviation 16.62
|
Adverse Events
ALLN-177
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ALLN-177
n=16 participants at risk
ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Number of events 1 • Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
4/16 • Number of events 4 • Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16 • Number of events 2 • Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • Number of events 2 • Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
18.8%
3/16 • Number of events 3 • Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.2%
1/16 • Number of events 1 • Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16 • Number of events 3 • Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 2 • Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
6.2%
1/16 • Number of events 1 • Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.2%
1/16 • Number of events 1 • Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60