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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Reloxaliase 		Reloxaliase (ALLN-177) 142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) per capsule
  • Drug: Reloxaliase
    Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day
    Other names:
    • ALLN-177
    • Oxalate decarboxylase
Placebo Comparator
placebo 		placebo capsule
  • Drug: Placebo
    Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day
    Other names:
    • Placebo capsule

Recruiting Locations

More Details

NCT ID
NCT03847090
Status
Terminated
Sponsor
Allena Pharmaceuticals

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.