Dietary Hyperoxaluria, Hyperoxaluria, Kidney Stones, Nephrolithiasis, Secondary Hyperoxaluria
Conditions
Keywords
Urine Oxalate, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Enteric Hyperoxaluria, Idiopathic Hyperoxaluria, Urological Diseases, Kidney Diseases, Supersaturation, Dietary Oxalate
Brief summary
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.
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 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.
Interventions
DRUGALLN-177
ALLN-177 7,500 units (5 capsules) PO TID with meals
DRUGPlacebo
Placebo 5 capsules PO TID with meals
Sponsors
Allena Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in urinary oxalate excretion (mg/24h) | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in urinary oxalate excretion | 28 days |
| ≥ 7.5 mg/24 hr decrease in urinary oxalate | 28 days |
| ≥ 10 mg/24 hr decrease in urinary oxalate | 28 days |
| Mean change in urinary supersaturation of calcium oxalate | 28 days |
| Time-weighted average urinary oxalate excretion (mg/24h) | 28 days |
Countries
United States
Outcome results
None listed