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

A Phase 2 Multicenter, Open Label, Single Arm Study Evaluating the Effect of ALLN-177 to Reduce Urinary Oxalate Excretion in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

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.

A multi-center, open-label, single arm study to evaluate the safety and the effect of ALLN-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. The study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with ALLN-177 and 4-day follow up period.

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