Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.

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

Details

• Lead Sponsor: Allena Pharmaceuticals
• Treatments: Calcium, Dietary

Criteria

Inclusion Criteria:

• Able to provide informed consent

• Able to comply with study procedures

• History of enteric or idiopathic hyperoxaluria and at least one calcium oxalate kidney stone

• Hyperoxaluria >36mg of oxalate/24-hr

• May be taking drugs for the prevention of stone disease as long as there have been no changes in these medications for at least 3 months

Exclusion Criteria:

• Uric acid ≥1.5g/24-hr

• Estimated glomerular filtration rate of < 60 mL/min

• Positive results from drug urine screen

• Requires daily vitamin C (defined as >10 days of >300 mg/day)

• Diagnosis of 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.

• Auto-immune disorder requiring high dose steroids or other immunosuppressant drugs.

• Subjects who are pregnant. Women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice approved methods of birth control during the trial

• History of cancer diagnosis except for within the past 5 years excluding dermal squamous and/or basal cell carcinoma or cervical carcinoma in situ.

• Taken investigational compound within 30 days prior to the first day of the study

• Treatment with cholestyramine

• Average daily dietary intake of <75 mg oxalate per day calculated from diet recalls