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

  • STATUS
    Recruiting
  • End date
    Nov 22, 2023
  • participants needed
    200
  • sponsor
    Allena Pharmaceuticals
Updated on 22 July 2021

Summary

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

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.

Details
Condition Enteric Hyperoxaluria
Treatment Placebo, Reloxaliase
Clinical Study IdentifierNCT03847090
SponsorAllena Pharmaceuticals
Last Modified on22 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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