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

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

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.

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

Details

• Lead Sponsor: Allena Pharmaceuticals

Criteria

Inclusion Criteria:

• History of enteric or idiopathic hyperoxaluria or kidney stones

• Urinary oxalate ≥ 50 mg/24 hours

Exclusion Criteria:

• Hyperuricosuria

• Glomerular filtration rate < 45 mL/min/1.73m2

• Hypercalcemia or hyperthyroidism

• Autoimmune disorder requiring systemic steroids

• Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure