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

Nephrolithiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503345
• Other study ID #: 0000649
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2015
• Last updated: January 9, 2018
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Allena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Dietary Hyperoxaluria
• Hyperoxaluria
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Secondary Hyperoxaluria

Intervention

Drug:
• ALLN-177 low dose
ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day
• ALLN-177 mid dose
ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day
• ALLN-177 high dose
ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day
• Placebo
Placebo: 1, 2 or 5 capsules with meals PO 3 times per day

Locations

Country	Name	City	State
United States	Anne Arundel Urology	Annapolis	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	Northwestern Feinberg School Of Medicine - Urology Department	Chicago	Illinois
United States	The Urology Group	Cincinnati	Ohio
United States	Cleveland Clinic-Urology	Cleveland	Ohio
United States	UT Southwestern Medical Center - Urology	Dallas	Texas
United States	Atlantic Urological Associates	Daytona Beach	Florida
United States	IU Health Physicians Urology	Indianapolis	Indiana
United States	Mayo Clinic - Nephrology And Hypertension	Jacksonville	Florida
United States	North Shore Long Island Jewish Health System/The Arthur Miller Institute for Urology	Lake Success	New York
United States	Tower Urology	Los Angeles	California
United States	New York University - Division Of Nephrology	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Urology of Virginia	Virginia Beach	Virginia
United States	Omega Clinical Research	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Allena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean urinary oxalate excretion (mg/24 h) following treatment		on 7 days of treatment
Secondary	Change from baseline in mean urinary oxalate excretion (mg/24 h)		on 7 days of treatment