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

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

Sponsors

Lead sponsor: Allena Pharmaceuticals

Source 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.

Overall Status Completed
Start Date September 2015
Completion Date January 2017
Primary Completion Date January 2017
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean change in urinary oxalate excretion (mg/24h) 28 days
Secondary Outcome
Measure Time Frame
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
Mean change in urinary supersaturation of calcium oxalate 28 days
Time-weighted average urinary oxalate excretion (mg/24h) 28 days
Enrollment 66
Condition
Intervention

Intervention type: Drug

Intervention name: ALLN-177

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

Arm group label: ALLN-177

Other name: Oxalate decarboxylase

Intervention type: Drug

Intervention name: Placebo

Description: Placebo 5 capsules PO TID with meals

Arm group label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Annamaria Kausz, MD MS Study Director VP Clinical Development
Location
facility
Mayo Clinica Arizona | Pheonix, Arizona, 85054, United States
Urological Associates of Southern Arizona, PC | Tuscon, Arizona, 85741, United States
Applied Research Center of Arkansas, Inc. | Little Rock, Arkansas, 72212, United States
South Florida Medical Research, LLC | Aventura, Florida, 33180, United States
Atlantic Urological Associates | Daytona Beach, Florida, 32114, United States
Clinical Research Center of Florida | Pompano Beach, Florida, 33060, United States
Idaho Urological Institute | Meridian, Idaho, 83642, United States
IU Health Physicians Urology | Indianapolis, Indiana, 46202, United States
Regional Urology, LLC | Shreveport, Louisiana, 71106, United States
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States
Mayo Clinic Department of Medicine Clinical Trials Unit | Rochester, Minnesota, 555905, United States
Delaware Valley Urology, LLC | Voorhees, New Jersey, 08043, United States
Premier Medical Group of the Hudson Valley | Poughkeepsie, New York, 12601, United States
Associated Urologists of North Carolina | Raleigh, North Carolina, 27612, United States
Coastal Urology | Wilmington, North Carolina, 28401, United States
Tristate Urologic Services PSC INC. DBA The Urology group | Cincinnati, OH, Ohio, 45212, United States
Clinical Research Solutions, LLC | Middleburg Heights, Ohio, 44130, United States
Omega Medical Research | Warwick, Rhode Island, 02886, United States
Carolina Urologic Research Center | Myrtle Beach, South Carolina, 29572, United States
Urology Clinics of North Texas PLLC | Dallas, Texas, 75231, United States
Urology of Virginia | Virginia Beach, Virginia, 23462, United States
Integrity Medical Research | Mountlake Terrace, Washington, 98043, United States
Location Countries

United States

Verification Date

January 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals

Arm group label: ALLN-177

Arm group type: Experimental

Description: Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov