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

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.

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Key information

Conditions

Hyperoxaluria Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Indiana University Physicians Urology, Indianapolis, Indiana, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALLN-177

Drug

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.

Other names: Oxalate degrading enzyme, Oxalate decarboxylase

Primary outcomes

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

Time frame: 7 days

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).

Secondary outcomes

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

Time frame: 7 days

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%

Sponsors and collaborators

Lead sponsor

Allena Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2 Multicenter, Open Label, Single Arm Study Evaluating the Effect of ALLN-177 to Reduce Urinary Oxalate Excretion in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 13, 2014
Registry last updated: Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed