Status:
TERMINATED
Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
Lead Sponsor:
Allena Pharmaceuticals
Conditions:
Enteric Hyperoxaluria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 u...
Eligibility Criteria
Inclusion
- Provided informed consent
- Age 18 years or older
- Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy)
- Urinary oxalate ≥ 50 mg/24 hr
- Has at least 1 documented kidney stone within 2 years
Exclusion
- Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30 mL/minute/1.73 m2
- Has a known genetic, congenital, or other cause of kidney stones
- Unable or unwilling to discontinue Vitamin C supplementation \>200mg daily
- Cannot establish baseline kidney stone burden
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03847090
Start Date
August 26 2019
End Date
May 19 2022
Last Update
June 10 2022
Active Locations (113)
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1
University of Alabama- Department of Urology
Birmingham, Alabama, United States, 35234
2
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States, 36608
3
Aventiv Research Inc.
Mesa, Arizona, United States, 85210
4
Arizona Kidney Disease and Hypertension Center (AKDHC)- Phoenix
Peoria, Arizona, United States, 85381