Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

Study Overview
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Brief Summary
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Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria

Detailed Description
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Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria . Approximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.

Official Title
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Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

Conditions
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Enteric Hyperoxaluria, Primary Hyperoxaluria, Hyperoxalemia

Intervention / Treatment
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* Drug: ALLN-177


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed a informed consent form or an assent Aged 12 or older with body weight ≥ 35kg History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome) Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2 In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening Patients on dialysis, must be stable for greater than 3 months Exclusion Criteria: 1. Unable or unwilling to discontinue Vitamin C supplementation

Ages Eligible for Study
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Minimum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALLN-177<br>ALLN-177 7,500 units (2 capsules) | Drug: ALLN-177<br>* ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks<br>* Other names: Oxalate decarboxylase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma oxalate | Efficacy will be assessed based on change from baseline in plasma oxalate | on 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hr urinary oxalate excretion | Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion | on 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxalate, Kidney Stones, oxalate nephropathy, systemic oxalosis