Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

Allena Pharmaceuticals16 enrolled

Overview

The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.

A multi-center, open-label, single arm study to evaluate the safety and the effect of ALLN-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. The study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with ALLN-177 and 4-day follow up period.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperoxaluria Nephrolithiasis

Interventions

ALLN-177DRUG

ALLN-177 is orally administered oxalate decarboxylase (OxDc). The goal of oral therapy with ALLN-177 is to enzymatically degrade both dietary oxalate and endogenously produced oxalate secreted in the gastrointestinal tract resulting in decreased absorption and reduced urinary oxalate excretion.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Able to provide informed consent * Able to comply with study procedures * History of enteric or idiopathic hyperoxaluria and at least one calcium oxalate kidney stone * Hyperoxaluria \>36mg of oxalate/24-hr * May be taking drugs for the prevention of stone disease as long as there have been no changes in these medications for at least 3 months Exclusion Criteria: * Uric acid ≥1.5g/24-hr * Estimated glomerular filtration rate of \< 60 mL/min * Positive results from drug urine screen * Requires daily vitamin C (defined as \>10 days of \>300 mg/day) * Diagnosis of 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. * Auto-immune disorder requiring high dose steroids or other immunosuppressant drugs. * Subjects who are pregnant. Women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice approved methods of birth control during the trial * History of cancer diagnosis except for within the past 5 years excluding dermal squamous and/or basal cell carcinoma or cervical carcinoma in situ. * Taken investigational compound within 30 days prior to the first day of the study * Treatment with cholestyramine * Average daily dietary intake of \<75 mg oxalate per day calculated from diet recalls

Locations (4)

Indiana University Physicians Urology

Indianapolis, Indiana, United States

North Shore Long Island Jewish Health System

Lake Success, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Omega Clinical Research

Warwick, Rhode Island, United States

Outcomes

Primary Outcomes

Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion

Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).

Time frame: 7 days

Secondary Outcomes

Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion

Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100%

Time frame: 7 days

Data from ClinicalTrials.gov

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