Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
Purpose
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase 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 years or older 3. Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy) 4. Urinary oxalate ≥ 50 mg/24 hr 5. Has at least 1 documented kidney stone within 2 years
Exclusion Criteria
- Acute renal failure or estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2 2. Has a known genetic, congenital, or other cause of kidney stones 3. Unable or unwilling to discontinue Vitamin C supplementation >200mg daily 4. Cannot establish baseline kidney stone burden
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 Reloxaliase |
Reloxaliase (ALLN-177) 142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) per capsule |
|
|
Placebo Comparator placebo |
placebo capsule |
|
More Details
- Status
- Terminated
- Sponsor
- Allena Pharmaceuticals
Study Contact
Detailed Description
This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.