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Completed

NCT Number: NCT02503345

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tower Urology, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ALLN-177 low dose

Drug

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

Other names: Oxalate decarboxylase

ALLN-177 mid dose

Drug

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

Other names: Oxalate decarboxylase

ALLN-177 high dose

Drug

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

Other names: Oxalate decarboxylase

Placebo

Drug

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

Primary outcomes

  1. Mean urinary oxalate excretion (mg/24 h) following treatment

    Time frame: on 7 days of treatment

Secondary outcomes

  1. Change from baseline in mean urinary oxalate excretion (mg/24 h)

    Time frame: on 7 days of treatment

Sponsors and collaborators

Lead sponsor

Allena Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 21, 2015
Registry last updated
Jan 11, 2018

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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