Clinical trial NCT02547805: Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperoxaluria
Nephrolithiasis
Hyperoxaluria
Kidney Stones
Dietary Hyperoxaluria
Keywords: Urine Oxalate
Nephrolithiasis
Kidney Stones
Hyperoxaluria
Enteric Hyperoxaluria
Idiopathic Hyperoxaluria
Urological Diseases
Kidney Diseases
Supersaturation
Dietary Oxalate
Lead sponsor: Allena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change in urinary oxalate excretion (mg/24h)
timeFrame: 28 days
Secondary outcomes:
measure: Percent change in urinary oxalate excretion
timeFrame: 28 days
measure: ≥ 7.5 mg/24 hr decrease in urinary oxalate
timeFrame: 28 days
measure: ≥ 10 mg/24 hr decrease in urinary oxalate
timeFrame: 28 days
measure: Mean change in urinary supersaturation of calcium oxalate
timeFrame: 28 days
measure: Time-weighted average urinary oxalate excretion (mg/24h)
timeFrame: 28 days
Other outcomes:
Locations:
city: Pheonix
country: United States
facility: Mayo Clinica Arizona
state: Arizona
city: Tuscon
country: United States
facility: Urological Associates of Southern Arizona, PC
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas, Inc.
state: Arkansas
city: Aventura
country: United States
facility: South Florida Medical Research, LLC
state: Florida
city: Daytona Beach
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Meridian
country: United States
facility: Idaho Urological Institute
state: Idaho
city: Indianapolis
country: United States
facility: IU Health Physicians Urology
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Department of Medicine Clinical Trials Unit
state: Minnesota
city: Voorhees
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Wilmington
country: United States
facility: Coastal Urology
state: North Carolina
city: Cincinnati, OH
country: United States
facility: Tristate Urologic Services PSC INC. DBA The Urology group
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions, LLC
state: Ohio
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Dallas
country: United States
facility: Urology Clinics of North Texas PLLC
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research
state: Washington
Study officials:
affiliation: VP Clinical Development
name: Annamaria Kausz, MD MS
role: STUDY_DIRECTOR
References: