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

NCT02503345 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-01-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.

Conditions

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

Interventions

DRUG

ALLN-177 low dose

ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day

DRUG

ALLN-177 mid dose

ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day

DRUG

ALLN-177 high dose

ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day

DRUG

Placebo

Placebo: 1, 2 or 5 capsules with meals PO 3 times per day

Sponsors & Collaborators

  • Allena Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Annamaria Kausz, MD MS · VP Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-08-31
Completion
2017-01-31
FDA Drug
Yes

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 NCT02503345 on ClinicalTrials.gov