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



Status:Recruiting
Conditions:Nephrology, Nephrology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:5/14/2016
Start Date:September 2015
End Date:June 2016
Contact:Annamaria Kausz, MD MS
Email:akausz@allenapharma.com
Phone:617-467-4577

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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

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.

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 44 subjects.

Inclusion Criteria:

- History of enteric or idiopathic hyperoxaluria and at least one kidney stone within
the last two years.

Exclusion Criteria:

- Hyperuricemia

- 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
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