Trial Outcomes & Findings for Hydroxyproline Influence on Oxalate Metabolism (NCT NCT02038543)
NCT ID: NCT02038543
Last Updated: 2017-07-02
Results Overview
The overall contribution of hydroxyproline catabolism to urinary oxalate (UOx) and glycolate (UGlc) excretion is determined by the excess mole percent enrichment of urine with 13C2-oxalate and glycolate corrected for the fraction of labelled \[15N,13C5\]-Hyp that is circulating in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Participants will be followed for the duration of study infusion and observation, an average of 24 hours.
Results posted on
2017-07-02
Participant Flow
Subjects were enrolled at Mayo Clinic in Rochester, Minnesota.
Participant milestones
| Measure |
PH Type 1
In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
|
PH Type 2
Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
|
PH Type 3
In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
|
PH Type Non 1,2,3
Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as primary hyperoxaluria (PH) types 1, 2, or 3.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
8
|
3
|
|
Overall Study
COMPLETED
|
7
|
4
|
8
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
PH Type 1
In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
|
PH Type 2
Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
|
PH Type 3
In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
|
PH Type Non 1,2,3
Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as primary hyperoxaluria (PH) types 1, 2, or 3.
|
|---|---|---|---|---|
|
Overall Study
Screen Failure
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Hydroxyproline Influence on Oxalate Metabolism
Baseline characteristics by cohort
| Measure |
PH Type 1
n=7 Participants
In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
|
PH Type 2
n=4 Participants
Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
|
PH Type 3
n=8 Participants
In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
|
PH Type Non 1,2,3
n=3 Participants
Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified a PH types 1, 2, or 3.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
3 participants
n=4 Participants
|
22 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of study infusion and observation, an average of 24 hours.Population: 2 subjects from the PH Type Non 1,2,3 withdrew from the study. Subjects with PH Type Non 1,2,3 were not included in the analysis as only 1 subject completed the study.
The overall contribution of hydroxyproline catabolism to urinary oxalate (UOx) and glycolate (UGlc) excretion is determined by the excess mole percent enrichment of urine with 13C2-oxalate and glycolate corrected for the fraction of labelled \[15N,13C5\]-Hyp that is circulating in the plasma.
Outcome measures
| Measure |
PH Type 1
n=7 Participants
In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
|
PH Type 2
n=4 Participants
Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
|
PH Type 3
n=8 Participants
In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
|
PH Type Non 1,2,3
Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as PH types 1, 2, or 3.
|
|---|---|---|---|---|
|
Mean Percent Conversion of Hydroxyproline (Hyp) to Urinary Oxalate (UOx)
|
12.8 percent converted
Standard Error 4.7
|
32.9 percent converted
Standard Error 8.0
|
14.8 percent converted
Standard Error 1.8
|
—
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of the study infusion and observations, an average of 24 hoursPopulation: 2 subjects from the PH Type Non 1,2,3 withdrew from the study. Subjects with PH Type Non 1,2,3 were not included in the analysis as only 1 subject completed the study.
The overall contribution of Hyp catabolism to urinary oxalate (UOx) and glycolate (UGlc) excretion is determined by the excess mole percent enrichment of urine with 13C2-oxalate and glycolate corrected for the fraction of labelled \[15N,13C5\]-Hyp that is circulating in the plasma.
Outcome measures
| Measure |
PH Type 1
n=7 Participants
In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
|
PH Type 2
n=4 Participants
Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
|
PH Type 3
n=8 Participants
In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
|
PH Type Non 1,2,3
Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as PH types 1, 2, or 3.
|
|---|---|---|---|---|
|
Mean Percent Conversion of Hydroxyproline (Hyp) to Urinary Glycolate (UGIc)
|
16.3 percent converted
Standard Error 4.0
|
1.4 percent converted
Standard Error 0.4
|
2.5 percent converted
Standard Error 1.3
|
—
|
Adverse Events
PH Type 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PH Type 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PH Type 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PH Type Non 1,2,3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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