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Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

NCT03456830 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2020-02-27

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

Conditions

  • Enteric Hyperoxaluria

Interventions

DRUG

ALLN-177

ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days

DRUG

Placebo

Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days

Sponsors & Collaborators

  • Allena Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Annamaria Kausz, MD MS · 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
2018-05-21
Primary Completion
2019-09-30
Completion
2019-10-28
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • 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 NCT03456830 on ClinicalTrials.gov