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Completed

NCT Number: NCT03456830

Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

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Key information

Conditions

Enteric Hyperoxaluria Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperoxaluria Kidney Calculi Kidney Diseases 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 3

Primary location

University of Alberta, Division of Urology, Edmonton, Alberta, Canada

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About this study

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population compared to placebo.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provided informed consent
  • Age 18 or older
  • History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
  • Urinary Oxalate ≥ 50mg/24h

Exclusion criteria

  • Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2
  • Unable or unwilling to discontinue Vitamin C supplementation

Treatment and study plan

ALLN-177

Drug

ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days

Other names: Oxalate decarboxylase

Placebo

Drug

Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days

Primary outcomes

  1. Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4

    Time frame: 4 weeks

    Efficacy will be assessed based on percent change from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment

Secondary outcomes

  1. Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4

    Time frame: 4 weeks

    Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment

Sponsors and collaborators

Lead sponsor

Allena Pharmaceuticals

Industry

Registry information

Official study title

Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2018
Registry last updated
Feb 27, 2020

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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