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Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days

NCT02547805 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2017-01-19

No results posted yet for this study

Summary

Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.

Conditions

  • Secondary Hyperoxaluria
  • Nephrolithiasis
  • Hyperoxaluria
  • Kidney Stones
  • Dietary Hyperoxaluria

Interventions

DRUG

ALLN-177

ALLN-177 7,500 units (5 capsules) PO TID with meals

DRUG

Placebo

Placebo 5 capsules PO TID with meals

Sponsors & Collaborators

  • Allena Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Annamaria Kausz, MD MS · VP Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

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 NCT02547805 on ClinicalTrials.gov