Enteric Hyperoxaluria
Conditions
Keywords
Kidney stones, Hyperoxaluria, Enteric hyperoxaluria, Oxalate
Brief summary
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
Detailed description
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population compared to placebo.
Interventions
DRUGALLN-177
ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days
DRUGPlacebo
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days
Sponsors
Allena Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provided informed consent 2. Age 18 or older 3. History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome) 4. Urinary Oxalate ≥ 50mg/24h
Exclusion criteria
1. Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30mL/min/1.73 m2 2. Unable or unwilling to discontinue Vitamin C supplementation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4 | 4 weeks | Efficacy will be assessed based on percent change from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4 | 4 weeks | Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment |
Countries
Canada, France, Germany, Italy, Spain, United Kingdom, United States
Outcome results
None listed