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

Phase 3

Terminated

• Conditions: Enteric Hyperoxaluria
• Interventions: Drug: Placebo; Drug: Reloxaliase

• Registration Number: NCT03847090
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Study Start: 2019-08-26
• Primary Completion: 2022-05-19
• Study Completion: 2022-05-19
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4	4 weeks	Efficacy will be assessed based on percent change from baseline to the average across Weeks 1 to 4, derived from all 24-hour collections during Weeks 1 to 4 on treatment
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	Efficacy will be assessed by comparing kidney stone disease progression event rate on reloxaliase vs. placebo

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24	24 weeks	Efficacy will be assessed based on percent change from baseline to the average across Weeks 16-24, derived from all 24-hour collections during Weeks 16-24 on treatment
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 average across Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones	up to 48 months	Efficacy will be assessed by comparing utilization on reloxaliase vs. placebo
Change in estimated glomerular filtration rate (eGFR) from baseline	up to 48 months	Efficacy will be assessed by comparing the rate of change in eGFR on reloxaliase vs. placebo

Trial Locations

Locations (113)

University of Alabama- Department of Urology; 🇺🇸 Birmingham, Alabama, United States

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

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