Clinical Trials Logo
  1. Home
  2. Kidney Stones
  3. NCT02547805

Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days

Nephrolithiasis Clinical Trial

Official title:
A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones

Clinical Trial Summary

Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.

Clinical Trial 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 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02547805
Study type Interventional
Source Allena Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date September 2015
Completion date January 2017
View Details
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04746378 - PRedictive Accuracy of Initial Stone Burden Evaluation.
Recruiting NCT05100017 - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure N/A
Recruiting NCT03692715 - Antibiotic Prophylaxis Before Shock Wave Lithotripsy Phase 4
Completed NCT02289755 - Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria Phase 2
Completed NCT01690039 - Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis
Completed NCT01650935 - Comparison of DASH With Oxalate Restricted Diet on Urine in Recurrent Stone Formers With Hyperoxaluria N/A
Completed NCT01295879 - Vitamin D Repletion in Stone Formers With Hypercalciuria Phase 4
Recruiting NCT05014178 - Kidney Sodium Functional Imaging
Not yet recruiting NCT06199102 - The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. N/A
Recruiting NCT04374188 - Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy N/A
Recruiting NCT04367155 - Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. N/A
Recruiting NCT05701098 - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) N/A
Recruiting NCT04389853 - Mini-PNCL vs fURS in Management of Nephrolithiasis N/A
Completed NCT03348228 - Effect of Hydroxycitrate on Urine Chemistry N/A
Completed NCT05350423 - Trial Assessing Renal Damage During Ureteroscopy N/A
Completed NCT03454139 - Subcostal TAP Block For Percutaneous Nephrolithotomy N/A
Recruiting NCT02279927 - Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy N/A
Completed NCT02276924 - Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors N/A
Completed NCT00159393 - Percutaneous Nephrolithotomy: A Registry and Database
Completed NCT02878148 - Conditional Imaging Prescription Strategy for Exploration of Acute Uncomplicated Renal Colic N/A