Evaluating the Effect of ALLN-177 to Reduce Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With 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