Expired Study
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Pheonix, Arizona 85054


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02547805


Primary Contact:

Study Director
Annamaria Kausz, MD MS
VP Clinical Development


Backup Contact:

N/A


Location Contact:

Pheonix, Arizona 85054
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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