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

Phase 2

Completed

• Conditions: Secondary Hyperoxaluria; Nephrolithiasis; Dietary Hyperoxaluria; Kidney Stones; Hyperoxaluria
• Interventions: Drug: Placebo; Drug: ALLN-177

• Registration Number: NCT02547805
• Lead Sponsor: Allena Pharmaceuticals

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-11
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals
ALLN-177	ALLN-177	Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals

Primary Outcome Measures

Name	Time	Method
Mean change in urinary oxalate excretion (mg/24h)	28 days

Secondary Outcome Measures

Name	Time	Method
Time-weighted average urinary oxalate excretion (mg/24h)	28 days
Mean change in urinary supersaturation of calcium oxalate	28 days
Percent change in urinary oxalate excretion	28 days
≥ 7.5 mg/24 hr decrease in urinary oxalate	28 days
≥ 10 mg/24 hr decrease in urinary oxalate	28 days

Trial Locations

Locations (22)

Mayo Clinica Arizona; 🇺🇸 Pheonix, Arizona, United States

Urological Associates of Southern Arizona, PC; 🇺🇸 Tuscon, Arizona, United States

Applied Research Center of Arkansas, Inc.; 🇺🇸 Little Rock, Arkansas, United States

South Florida Medical Research, LLC; 🇺🇸 Aventura, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Premier Medical Group of the Hudson Valley; 🇺🇸 Poughkeepsie, New York, United States

Clinical Research Solutions, LLC; 🇺🇸 Middleburg Heights, Ohio, United States

Clinical Research Center of Florida; 🇺🇸 Pompano Beach, Florida, United States

Idaho Urological Institute; 🇺🇸 Meridian, Idaho, United States

Atlantic Urological Associates; 🇺🇸 Daytona Beach, Florida, United States

Associated Urologists of North Carolina; 🇺🇸 Raleigh, North Carolina, United States

IU Health Physicians Urology; 🇺🇸 Indianapolis, Indiana, United States

Regional Urology, LLC; 🇺🇸 Shreveport, Louisiana, United States

Mayo Clinic Department of Medicine Clinical Trials Unit; 🇺🇸 Rochester, Minnesota, United States

Delaware Valley Urology, LLC; 🇺🇸 Voorhees, New Jersey, United States

Coastal Urology; 🇺🇸 Wilmington, North Carolina, United States

Tristate Urologic Services PSC INC. DBA The Urology group; 🇺🇸 Cincinnati, OH, Ohio, United States

Omega Medical Research; 🇺🇸 Warwick, Rhode Island, United States

Urology Clinics of North Texas PLLC; 🇺🇸 Dallas, Texas, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Integrity Medical Research; 🇺🇸 Mountlake Terrace, Washington, United States

Urology of Virginia; 🇺🇸 Virginia Beach, Virginia, United States