Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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)

Details

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.

Keywords

Enteric Hyperoxaluria kidney stone hyperoxaluria oxalate kidney calcification Reloxaliase

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • University of California, San Diego (UCSD) Health System accepting new patients
    San Diego California 92103 United States
  • Urological Associates of Southern Arizona accepting new patients
    Tucson Arizona 85715 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allena Pharmaceuticals
Links
A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme ALLN-177, oral enzyme therapy for hyperoxaluria
ID
NCT03847090
Phase
Phase 3
Study Type
Interventional
Last Updated