Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Enteric Hyperoxaluria
In brief
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.
Key facts
- Study ID
- NCT03847090
- Run by
- Allena Pharmaceuticals
- People needed
- 92
- Starts
- 2019-08-26
- Expected to finish
- 2022-05-19
- Last updated by the study team
- 2022-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Alliance for Multispecialty Research, LLC — Mobile, Alabama, United States
- Aventiv Research Inc. — Mesa, Arizona, United States
- Arizona Kidney Disease and Hypertension Center (AKDHC)- Phoenix — Peoria, Arizona, United States
- Arizona Kidney Disease and Hypertension Center (AKDHC)- Glendale — Phoenix, Arizona, United States
- Mayo Mercy Hospital — Phoenix, Arizona, United States
- Urological Associates of Southern Arizona — Tucson, Arizona, United States
- Banner University Medical Center — Tucson, Arizona, United States
- Arkansas Urology — Little Rock, Arkansas, United States
- Applied Research Center of Arkansas — Little Rock, Arkansas, United States
- Renal Consultants Medical Group — Granada Hills, California, United States
- Amicis Research — Northridge, California, United States
- University of California, San Diego (UCSD) Health System — San Diego, California, United States
- University of California- San Francisco (UCSF) — San Francisco, California, United States
- Stanford University School of Medicine — Stanford, California, United States
- Sutter Health- Sacramento — Vacaville, California, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- South Florida Nephrology Group PA Research Div — Coral Springs, Florida, United States
- University of Florida College of Medicine — Gainesville, Florida, United States
- Quantum Clinical Research — Hialeah, Florida, United States
- Mayo Clinic — Jacksonville, Florida, United States
- Pro-Care Research Center, Corp — Miami Gardens, Florida, United States
- Avanza Medical Research Center — Pensacola, Florida, United States
- University of South Florida — Tampa, Florida, United States
- Idaho Catalyst Clinical Research — Idaho Falls, Idaho, United States
- University of Alabama- Department of Urology — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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