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

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

Sponsors

Lead sponsor: Allena Pharmaceuticals

Source Allena Pharmaceuticals
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.

Overall Status Completed
Start Date July 2015
Completion Date January 2017
Primary Completion Date August 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean urinary oxalate excretion (mg/24 h) following treatment on 7 days of treatment
Secondary Outcome
Measure Time Frame
Change from baseline in mean urinary oxalate excretion (mg/24 h) on 7 days of treatment
Enrollment 32
Condition
Intervention

Intervention type: Drug

Intervention name: ALLN-177 low dose

Description: ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day

Arm group label: ALLN-177 low dose

Other name: Oxalate decarboxylase

Intervention type: Drug

Intervention name: ALLN-177 mid dose

Description: ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day

Arm group label: ALLN-177 mid dose

Other name: Oxalate decarboxylase

Intervention type: Drug

Intervention name: ALLN-177 high dose

Description: ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day

Arm group label: ALLN-177 high dose

Other name: Oxalate decarboxylase

Intervention type: Drug

Intervention name: Placebo

Description: Placebo: 1, 2 or 5 capsules with meals PO 3 times per day

Arm group label: Placebo

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

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
Tower Urology | Los Angeles, California, 90048, United States
Atlantic Urological Associates | Daytona Beach, Florida, 32114, United States
Mayo Clinic - Nephrology And Hypertension | Jacksonville, Florida, 32224, United States
Northwestern Feinberg School Of Medicine - Urology Department | Chicago, Illinois, 60611, United States
IU Health Physicians Urology | Indianapolis, Indiana, 46202, United States
Anne Arundel Urology | Annapolis, Maryland, 21401, United States
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States
Mayo Clinic | Rochester, Minnesota, 55902, United States
Brooklyn Urology Research Group | Brooklyn, New York, 11694, United States
North Shore Long Island Jewish Health System/The Arthur Miller Institute for Urology | Lake Success, New York, 11042, United States
New York University - Division Of Nephrology | New York, New York, 10016, United States
The Urology Group | Cincinnati, Ohio, 45212, United States
Cleveland Clinic-Urology | Cleveland, Ohio, 44195, United States
Omega Clinical Research | Warwick, Rhode Island, 02886, United States
UT Southwestern Medical Center - Urology | Dallas, Texas, 75390, United States
Urology of Virginia | Virginia Beach, Virginia, 23462, 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 4
Arm Group

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Placebo capsules (1, 2 or 5) PO TID

Arm group label: ALLN-177 low dose

Arm group type: Experimental

Description: ALLN-177 1,500 units/meal PO TID

Arm group label: ALLN-177 mid dose

Arm group type: Experimental

Description: ALLN-177 3,000 units/meal PO TID

Arm group label: ALLN-177 high dose

Arm group type: Experimental

Description: ALLN-177 7,500 units/meal PO TID

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov