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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones, Dietary Hyperoxaluria

Intervention / Treatment
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* Drug: ALLN-177
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of enteric or idiopathic hyperoxaluria or kidney stones Urinary oxalate ≥ 50 mg/24 hours Exclusion Criteria: Hyperuricosuria Glomerular filtration rate < 45 mL/min/1.73m2 Hypercalcemia or hyperthyroidism Autoimmune disorder requiring systemic steroids Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals | Drug: Placebo<br>* Placebo 5 capsules PO TID with meals<br>|
| Experimental: ALLN-177<br>Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals | Drug: ALLN-177<br>* ALLN-177 7,500 units (5 capsules) PO TID with meals<br>* Other names: Oxalate decarboxylase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in urinary oxalate excretion (mg/24h) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in urinary oxalate excretion |  | 28 days | 
| ≥ 7.5 mg/24 hr decrease in urinary oxalate |  | 28 days | 
| ≥ 10 mg/24 hr decrease in urinary oxalate |  | 28 days | 
| Mean change in urinary supersaturation of calcium oxalate |  | 28 days | 
| Time-weighted average urinary oxalate excretion (mg/24h) |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urine Oxalate, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Enteric Hyperoxaluria, Idiopathic Hyperoxaluria, Urological Diseases, Kidney Diseases, Supersaturation, Dietary Oxalate