Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

Allena Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Enteric Hyperoxaluria

Treatments: Drug: ALLN-177; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03456830

ALLN-177-301

Details and patient eligibility

About

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

Full description

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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provided informed consent
2. Age 18 or older
3. 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)
4. Urinary Oxalate ≥ 50mg/24h

Exclusion criteria

1. Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2
2. Unable or unwilling to discontinue Vitamin C supplementation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 2 patient groups, including a placebo group

ALLN-177

Experimental group

Description:

ALLN-177 3,750 units per capsule

Treatment:

Drug: ALLN-177

Placebo

Placebo Comparator group

Description:

Placebo capsule

Treatment:

Drug: Placebo