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

NCT03847090 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-06-10

No results posted yet for this study

Summary

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

Conditions

  • Enteric Hyperoxaluria

Interventions

DRUG

Reloxaliase

Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day

DRUG

Placebo

Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day

Sponsors & Collaborators

  • Allena Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • David Clark, MD · Allena Pharmaceuticals Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-26
Primary Completion
2022-05-19
Completion
2022-05-19
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Croatia
  • France
  • Germany
  • Italy
  • Mexico
  • Portugal
  • Romania
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847090 on ClinicalTrials.gov