Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
- Registration Number
- NCT03456830
- Lead Sponsor
- Allena Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- Provided informed consent
- Age 18 or older
- 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)
- Urinary Oxalate ≥ 50mg/24h
- Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2
- Unable or unwilling to discontinue Vitamin C supplementation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo capsule ALLN-177 ALLN-177 ALLN-177 3,750 units per capsule
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (63)
Urology Centers of Alabama
🇺🇸Birmingham, Alabama, United States
University of Alabama, Department of Urology
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Urological Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
TROVARE Clinical Research
🇺🇸Bakersfield, California, United States
Advanced Urology Institute
🇺🇸Daytona Beach, Florida, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Center for Advanced GI (CFAGI)
🇺🇸Maitland, Florida, United States
South Medical Research Group, Inc.
🇺🇸Miami, Florida, United States
Scroll for more (53 remaining)Urology Centers of Alabama🇺🇸Birmingham, Alabama, United States