Clinical trial NCT02503345: Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones
Official title: A Phase 2b, Multi-center, Randomized, Double Blind, Placebo-controlled, Crossover Study to Evaluate Multiple Doses of ALLN-177 in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperoxaluria
Nephrolithiasis
Kidney Stones
Hyperoxaluria
Dietary Hyperoxaluria
Keywords: Kidney Stones
Nephrolithiasis
Urine Oxalate
Hyperoxaluria
Enteric Hyperoxaluria
Idiopathic Hyperoxaluria
Urological Diseases
Kidney Diseases
Dietary Oxalate
Lead sponsor: Allena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-07-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for up to 60 subjects.

Eligibility criteria: Inclusion Criteria:

* History of enteric or idiopathic hyperoxaluria and at least one kidney stone within the past 2 years
* Hyperoxaluria at screening
* May be taking drugs for the prevention of stone disease

Exclusion Criteria:

* Hyperuricosuria
* Glomerular filtration rate \< 55 mL/min/1.73m2
* Hypercalcemia or hypothyroidism
* Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney
* Treatment with cholestyramine
* Average daily dietary intake of oxalate \<75 mg per day

Primary outcomes:
measure: Mean urinary oxalate excretion (mg/24 h) following treatment
timeFrame: on 7 days of treatment
Secondary outcomes:
measure: Change from baseline in mean urinary oxalate excretion (mg/24 h)
timeFrame: on 7 days of treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Daytona Beach
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Nephrology And Hypertension
state: Florida
city: Chicago
country: United States
facility: Northwestern Feinberg School Of Medicine - Urology Department
state: Illinois
city: Indianapolis
country: United States
facility: IU Health Physicians Urology
state: Indiana
city: Annapolis
country: United States
facility: Anne Arundel Urology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Brooklyn
country: United States
facility: Brooklyn Urology Research Group
state: New York
city: Lake Success
country: United States
facility: North Shore Long Island Jewish Health System/The Arthur Miller Institute for Urology
state: New York
city: New York
country: United States
facility: New York University - Division Of Nephrology
state: New York
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic-Urology
state: Ohio
city: Warwick
country: United States
facility: Omega Clinical Research
state: Rhode Island
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Urology
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
Study officials:
affiliation: VP Clinical Development
name: Annamaria Kausz, MD MS
role: STUDY_DIRECTOR
References: