Trial Outcomes & Findings for A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria (NCT NCT03095885)

NCT ID: NCT03095885

Last Updated: 2021-10-28

Results Overview

Percent of oxalate absorption normalized by baseline was calculated by 100\*\[UOx/test - UOx/baseline\]/Ox intake from the test meal.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 24 hours during baseline and test day following oxalate-rich meal
• Results posted on: 2021-10-28

Participant Flow

Participant milestones

Measure	Test Meal controlled oxalate-rich test meal
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

Baseline characteristics by cohort

Measure	Enrolled Set n=22 Participants The Enrolled Set included all subjects who were determined to be eligible for the study after screening assessments and were enrolled in the study.
Age, Continuous	57.3 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	10 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	20 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
BMI (kg/m^2)	33.45 kg/m^2 STANDARD_DEVIATION 8.04 • n=5 Participants
Estimated glomerular filtration rate	80.7 mL/minute/1.73 /m^2 STANDARD_DEVIATION 17.4 • n=5 Participants
Hyperoxaluria Classification Idiopathic Hyperoxaluria	17 Participants n=5 Participants
Hyperoxaluria Classification Enteric Hyperoxaluria	5 Participants n=5 Participants
Number of Kidney Stone Episodes at Study Entry	5 Episodes STANDARD_DEVIATION 5.37 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours during baseline and test day following oxalate-rich meal

Population: Enrolled set which included all enrolled subjects

Percent of oxalate absorption normalized by baseline was calculated by 100*[UOx/test - UOx/baseline]/Ox intake from the test meal.

Outcome measures

Measure	Test Meal n=22 Participants controlled oxalate-rich test meal
Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period	2.84 percentage of oxalate absorption Standard Deviation 2.36

SECONDARY outcome

Timeframe: 0-4 hours post test meal, 0-6 hours post test meal, 0-24 hours post test meal

Population: Enrolled set which included all enrolled subjects

Percent of Oxalate absorption by test interval was calculated as the urinary oxalate excretions (mg) during the test interval divided by the amount of oxalate in the test meal.

Outcome measures

Measure	Test Meal n=22 Participants controlled oxalate-rich test meal
Percent of Oxalate Absorption By Test Interval 0-4 Hours post test meal	2.11 percentage of oxalate absorption Standard Deviation 0.52
Percent of Oxalate Absorption By Test Interval 0-6 hours post test meal	3.55 percentage of oxalate absorption Standard Deviation 0.88
Percent of Oxalate Absorption By Test Interval 0-24 hours post test meal	10.83 percentage of oxalate absorption Standard Deviation 3.04

SECONDARY outcome

Timeframe: 24 hours during baseline, 0 to 4 hours post test meal, 0-6 hours post test meal, 6-24 hours post test meal, 0-24 hours post test meal

Population: Enrolled set which included all enrolled subjects

Urinary oxalate (UOx) excretion was normalized to units of mg/g creatinine by dividing the UOx in mg by the creatinine value in g from the same collection. Percent change from baseline for UOx/Cr from Baseline was calculated by 100 * [UOx/Cr for the test interval - UOx/Cr at Baseline] / UOx/Cr at Baseline.

Outcome measures

Measure	Test Meal n=22 Participants controlled oxalate-rich test meal
Percent Change From Baseline for Urinary Oxalate to Creatinine Ratio by Test Interval 0-4 hours post test meal	68.17 Percentage of change of UOx/Cr Standard Deviation 93.05
Percent Change From Baseline for Urinary Oxalate to Creatinine Ratio by Test Interval 0-6 hours post test meal	84.73 Percentage of change of UOx/Cr Standard Deviation 100.05
Percent Change From Baseline for Urinary Oxalate to Creatinine Ratio by Test Interval 6-24 hours post test meal	45.39 Percentage of change of UOx/Cr Standard Deviation 62
Percent Change From Baseline for Urinary Oxalate to Creatinine Ratio by Test Interval 0-24 hours post test meal	47.14 Percentage of change of UOx/Cr Standard Deviation 64.82

Adverse Events

Test Meal

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Test Meal n=22 participants at risk controlled oxalate-rich test meal
Musculoskeletal and connective tissue disorders Arthritis	4.5% 1/22 • Number of events 1 • 34 days (adverse events were recorded from the time of informed consent until the last study visit, and the screening period was approximately 30 days) Since no investigational product was administered; no drug-related adverse events (AEs) occurred. The investigator assessed AEs by intensity (severity) and causality in relation to the study intervention, which was the study diet. Any untoward symptoms or worsening of medical conditions reported during the study were recorded as AEs.
Musculoskeletal and connective tissue disorders Trigger finger	4.5% 1/22 • Number of events 1 • 34 days (adverse events were recorded from the time of informed consent until the last study visit, and the screening period was approximately 30 days) Since no investigational product was administered; no drug-related adverse events (AEs) occurred. The investigator assessed AEs by intensity (severity) and causality in relation to the study intervention, which was the study diet. Any untoward symptoms or worsening of medical conditions reported during the study were recorded as AEs.
Nervous system disorders Headache	4.5% 1/22 • Number of events 1 • 34 days (adverse events were recorded from the time of informed consent until the last study visit, and the screening period was approximately 30 days) Since no investigational product was administered; no drug-related adverse events (AEs) occurred. The investigator assessed AEs by intensity (severity) and causality in relation to the study intervention, which was the study diet. Any untoward symptoms or worsening of medical conditions reported during the study were recorded as AEs.

Additional Information

Allena Medical Affairs

Allena Pharmaceuticals, Inc

Phone: 6174674577

Email: AllenaMedInfo@allenapharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER