Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Female Urogenital Diseases and Pregnancy Complications

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Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals

Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals

ALLN-177 7,500 units (5 capsules) PO TID with meals

ALLN-177

Placebo

Annamaria Kausz, MD MS

Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.

Eligible subjects will be randomized to 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.

Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones

Allena Pharmaceuticals

Test Meal

Annamaria Kausz, MD, MS

Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.

This was a prospective 4-day study of oxalate absorption in subjects with secondary hyperoxaluria. Subjects visited the research center three times for outpatient visits (Screening, Test Day 3, Day 4).

Subjects were instructed to follow a low-oxalate diet, consuming only study-specified food choices that had low or no oxalate and controlled calcium content Days 1 through 4 (Baseline Period through the Day 4 clinic visit) and, on Test Day 3, consumed an oxalate-rich test meal.

Subjects performed three 24-hour urine collections during Screening, Baseline Day 2, and Test Day 3. Test Day 3 included the oxalate-rich test meal and the subject collected a 24-hour urine separated into 4 urine collection intervals. (Pre-test meal, post-test meal to 4 hours, 4-6 hours post test meal and remaining time to complete 24 hours).

A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

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

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.

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.

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.

The Enrolled Set included all subjects who were determined to be eligible for the study after screening assessments and were enrolled in the study.

Enrolled Set

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

BMI (kg/m^2)

Estimated glomerular filtration rate

Hyperoxaluria Classification

Number of Kidney Stone Episodes at Study Entry

Allena Medical Affairs

Enrolled set which included all enrolled subjects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days	NCT02547805	Secondary Hyper... Nephrolithiasis Hyperoxaluria Kidney Stones Dietary Hyperox...	ALLN-177 Placebo	18 Years -	Allena Pharmaceuticals
A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria	NCT03095885	Secondary Hyper... Nephrolithiasis Hyperoxaluria Kidney Stones	Test Meal	18 Years -	Allena Pharmaceuticals

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