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

Allena Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Dietary Hyperoxaluria; Hyperoxaluria; Secondary Hyperoxaluria; Kidney Stones; Nephrolithiasis

Treatments: Drug: Placebo; Drug: ALLN-177

Study type: Interventional

Funder types: Industry

Identifiers

NCT02547805

0000713

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

ALLN-177

Experimental group

Description:

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

Treatment:

Drug: ALLN-177