Trial Outcomes & Findings for Oxazyme in Patients With Hyperoxaluria (NCT NCT01127087)
NCT ID: NCT01127087
Last Updated: 2012-12-24
Results Overview
The urinary oxalate per creatinine ratio is expressed as mg/g. Paired t-test will be used when comparing reduction of urinary oxalate resulting from treatment (versus baseline) for each subject group.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Baseline, Week 4
Results posted on
2012-12-24
Participant Flow
Participants were recruited from the Mayo Clinic, Rochester, Minnesota.
7 subjects were enrolled on the Idiopathic arm; of these 2 did not complete baseline collections, and 3 didn't qualify, so these 5 were excluded. 15 subjects were enrolled on the RYGB arm; of these, 3 never started the study and 2 did not qualify, so these 5 were excluded.
Participant milestones
| Measure |
RYGB CaOx Stone Formers
Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).
Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
|
Idiopathic Hyperoxaluria CaOx Stone Formers
Subjects with idiopathic hyperoxaluria.
Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
2
|
|
Overall Study
COMPLETED
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxazyme in Patients With Hyperoxaluria
Baseline characteristics by cohort
| Measure |
RYGB CaOx Stone Formers
n=8 Participants
Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
|
Idiopathic Hyperoxaluria CaOx Stone Formers
n=2 Participants
Subjects with idiopathic hyperoxaluria.
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
|
Total
n=10 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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4The urinary oxalate per creatinine ratio is expressed as mg/g. Paired t-test will be used when comparing reduction of urinary oxalate resulting from treatment (versus baseline) for each subject group.
Outcome measures
| Measure |
RYGB CaOx Stone Formers
n=8 Participants
Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
|
Idiopathic Hyperoxaluria CaOx Stone Formers
n=2 Participants
Subjects with idiopathic hyperoxaluria.
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
|
|---|---|---|
|
Urinary Oxalate Creatinine Ratio
Baseline
|
68.6 mg/g
Standard Deviation 36.4
|
38.7 mg/g
Standard Deviation 6.9
|
|
Urinary Oxalate Creatinine Ratio
Week 4
|
49.6 mg/g
Standard Deviation 27.9
|
34.7 mg/g
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksOxalate is a salt of oxalic acid produced by the body's metabolism and excreted in the urine, measured in this study in two, 24-hour, urine collections.
Outcome measures
| Measure |
RYGB CaOx Stone Formers
n=8 Participants
Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
|
Idiopathic Hyperoxaluria CaOx Stone Formers
n=2 Participants
Subjects with idiopathic hyperoxaluria.
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
|
|---|---|---|
|
Total Urinary Oxalate Excretion
Baseline
|
66.3 mg/24 hrs
Standard Deviation 28.0
|
43.2 mg/24 hrs
Standard Deviation 5.9
|
|
Total Urinary Oxalate Excretion
4 Weeks
|
44.5 mg/24 hrs
Standard Deviation 23.7
|
32.3 mg/24 hrs
Standard Deviation 3.2
|
Adverse Events
RYGB CaOx Stone Formers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Idiopathic Hyperoxaluria CaOx Stone Formers
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