Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

Detailed Description
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This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population compared to placebo.

Official Title
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Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study

Conditions
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Enteric 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: Provided informed consent Age 18 or older History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome) Urinary Oxalate ≥ 50mg/24h Exclusion Criteria: Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 Unable or unwilling to discontinue Vitamin C supplementation

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALLN-177<br>ALLN-177 3,750 units per capsule | Drug: ALLN-177<br>* ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days<br>* Other names: Oxalate decarboxylase;|
| Placebo Comparator: Placebo<br>Placebo capsule | Drug: Placebo<br>* Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4 | Efficacy will be assessed based on percent change from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4 | Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney stones, Hyperoxaluria, Enteric hyperoxaluria, Oxalate