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

Nephrolithiasis Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547805
• Other study ID #: 0000713
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2015
• Last updated: January 17, 2017
• Start date: September 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Allena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.

Eligible subjects will be randomized to 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of enteric or idiopathic hyperoxaluria or kidney stones

• Urinary oxalate = 50 mg/24 hours

Exclusion Criteria:

• Hyperuricosuria

• Glomerular filtration rate < 45 mL/min/1.73m2

• Hypercalcemia or hyperthyroidism

• Autoimmune disorder requiring systemic steroids

• Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure

Related Conditions & MeSH terms

• Calculi
• Dietary Hyperoxaluria
• Hyperoxaluria
• Kidney Calculi
• Kidney Stones
• Neoplasm Metastasis
• Nephrolithiasis
• Secondary Hyperoxaluria

Intervention

Drug:
• ALLN-177
ALLN-177 7,500 units (5 capsules) PO TID with meals
• Placebo
Placebo 5 capsules PO TID with meals

Locations

Country	Name	City	State
United States	South Florida Medical Research, LLC	Aventura	Florida
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tristate Urologic Services PSC INC. DBA The Urology group	Cincinnati, OH	Ohio
United States	Urology Clinics of North Texas PLLC	Dallas	Texas
United States	Atlantic Urological Associates	Daytona Beach	Florida
United States	IU Health Physicians Urology	Indianapolis	Indiana
United States	Applied Research Center of Arkansas, Inc.	Little Rock	Arkansas
United States	Idaho Urological Institute	Meridian	Idaho
United States	Clinical Research Solutions, LLC	Middleburg Heights	Ohio
United States	Integrity Medical Research	Mountlake Terrace	Washington
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Mayo Clinica Arizona	Pheonix	Arizona
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Mayo Clinic Department of Medicine Clinical Trials Unit	Rochester	Minnesota
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Urological Associates of Southern Arizona, PC	Tuscon	Arizona
United States	Urology of Virginia	Virginia Beach	Virginia
United States	Delaware Valley Urology, LLC	Voorhees	New Jersey
United States	Omega Medical Research	Warwick	Rhode Island
United States	Coastal Urology	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in urinary oxalate excretion (mg/24h)		28 days
Secondary	Percent change in urinary oxalate excretion		28 days
Secondary	= 7.5 mg/24 hr decrease in urinary oxalate		28 days
Secondary	= 10 mg/24 hr decrease in urinary oxalate		28 days
Secondary	Mean change in urinary supersaturation of calcium oxalate		28 days
Secondary	Time-weighted average urinary oxalate excretion (mg/24h)		28 days