Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
Purpose
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
Condition
- Enteric Hyperoxaluria
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 2. Unable or unwilling to discontinue Vitamin C supplementation
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental ALLN-177 |
ALLN-177 3,750 units per capsule |
|
Placebo Comparator Placebo |
Placebo capsule |
|
More Details
- Status
- Completed
- Sponsor
- Allena Pharmaceuticals
Study Contact
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.