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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02503345

Enrollment

Registered

2015-07-21

Start date

2015-07-31

Completion date

2017-01-31

Last updated

2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Hyperoxaluria, Hyperoxaluria, Kidney Stones, Nephrolithiasis, Secondary Hyperoxaluria

Keywords

Kidney Stones, Nephrolithiasis, Urine Oxalate, Hyperoxaluria, Enteric Hyperoxaluria, Idiopathic Hyperoxaluria, Urological Diseases, Kidney Diseases, Dietary Oxalate

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.

Interventions

DRUGALLN-177 low dose

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

DRUGALLN-177 mid dose

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

DRUGALLN-177 high dose

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean urinary oxalate excretion (mg/24 h) following treatment	on 7 days of treatment

Secondary

Measure	Time frame
Change from baseline in mean urinary oxalate excretion (mg/24 h)	on 7 days of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026