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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allena Pharmaceuticals

Criteria

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