A Phase 2b, Multi-center, Randomized, Double Blind, Placebo-controlled, Crossover Study to Evaluate Multiple Doses of ALLN-177 in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Secondary Hyperoxaluria
- Sponsor
- Allena Pharmaceuticals
- Enrollment
- 32
- Locations
- 16
- Primary Endpoint
- Mean urinary oxalate excretion (mg/24 h) following treatment
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.
Detailed 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 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study. The study allows for up to 60 subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •History of enteric or idiopathic hyperoxaluria and at least one kidney stone within the past 2 years
- •Hyperoxaluria at screening
- •May be taking drugs for the prevention of stone disease
Exclusion Criteria
- •Hyperuricosuria
- •Glomerular filtration rate \< 55 mL/min/1.73m2
- •Hypercalcemia or hypothyroidism
- •Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney
- •Treatment with cholestyramine
- •Average daily dietary intake of oxalate \<75 mg per day
Arms & Interventions
Placebo
Placebo capsules (1, 2 or 5) PO TID
Intervention: Placebo
ALLN-177 low dose
ALLN-177 1,500 units/meal PO TID
Intervention: ALLN-177 low dose
ALLN-177 mid dose
ALLN-177 3,000 units/meal PO TID
Intervention: ALLN-177 mid dose
ALLN-177 high dose
ALLN-177 7,500 units/meal PO TID
Intervention: ALLN-177 high dose
Outcomes
Primary Outcomes
Mean urinary oxalate excretion (mg/24 h) following treatment
Time Frame: on 7 days of treatment
Secondary Outcomes
- Change from baseline in mean urinary oxalate excretion (mg/24 h)(on 7 days of treatment)