Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria

Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)

Sponsors

Lead Sponsor: Allena Pharmaceuticals

Source Allena Pharmaceuticals
Brief Summary

The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.

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.

Overall Status Recruiting
Start Date August 26, 2019
Completion Date November 2023
Primary Completion Date November 2023
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4 4 weeks
Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging) up to 48 months
Secondary Outcome
Measure Time Frame
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24 24 weeks
Proportion of subjects with a ≥ 20% reduction from baseline in 24-hour urinary oxalate excretion during Weeks 1-4 4 weeks
Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones up to 48 months
Change in estimated glomerular filtration rate (eGFR) from baseline up to 48 months
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: Reloxaliase

Description: Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day

Arm Group Label: Reloxaliase

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day

Arm Group Label: placebo

Other Name: Placebo capsule

Eligibility

Criteria:

Inclusion Criteria:

1. 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:

1. 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Alicia Weeks, MD Study Director Allena Pharmaceuticals Inc
Overall Contact

Last Name: Allena Pharmaceuticals, Inc

Phone: 617-467-4577

Phone Ext.: 398

Email: [email protected]

Location
Facility: Status:
Urological Associates of Southern Arizona | Tucson, Arizona, 85715, United States Recruiting
Arkansas Urology | Little Rock, Arkansas, 72211, United States Recruiting
Applied Research Center of Arkansas | Little Rock, Arkansas, 72212, United States Recruiting
University of California, San Diego (UCSD) Health System | San Diego, California, 92103, United States Recruiting
Stanford University School of Medicine | Stanford, California, 94305, United States Recruiting
Yale University School of Medicine | New Haven, Connecticut, 06510, United States Recruiting
Idaho Urologic Institute | Meridian, Idaho, 83642, United States Recruiting
IU Health Physicians | Carmel, Indiana, 46032, United States Recruiting
Indiana University (IU) Nephrology | Indianapolis, Indiana, 46202, United States Recruiting
Regional Urology | Shreveport, Louisiana, 71106, United States Recruiting
The Urology Center, P.C./ GU Research Network | Omaha, Nebraska, 68114, United States Recruiting
Albert Einstein College of Medicine | Bronx, New York, 10461, United States Recruiting
Long Island Gastrointestinal Research Group | Great Neck, New York, 11023, United States Recruiting
Advanced Urology Centers of NY | Plainview, New York, 11803, United States Recruiting
University of North Carolina (UNC) - Chapel Hill | Chapel Hill, North Carolina, 27599, United States Recruiting
Associated Urologists of North Carolina | Raleigh, North Carolina, 27612, United States Recruiting
University of Cincinnati (UC) - Department of Nephrologyv | Cincinnati, Ohio, 45267, United States Recruiting
Houston Nephrology Group | Houston, Texas, 77024, United States Recruiting
Houston Metro Urology | Houston, Texas, 77027, United States Recruiting
Houston Methodist Hospital | Houston, Texas, 77030, United States Recruiting
Virginia Urology | Richmond, Virginia, 23235, United States Recruiting
Urology of Virginia | Virginia Beach, Virginia, 23462, United States Recruiting
University of Wisconsin - Division of Nephrology | Madison, Wisconsin, 53705, United States Recruiting
Silverado Research Inc | Victoria, British Columbia, V8T2C1, Canada Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Nephrology Department | Lausanne, CH 1011, Switzerland Recruiting
Location Countries

Canada

Switzerland

United States

Verification Date

August 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Reloxaliase

Type: Experimental

Description: Reloxaliase (ALLN-177) 142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) per capsule

Label: placebo

Type: Placebo Comparator

Description: placebo capsule

Acronym URIROX-2
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov