Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria
Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria . Approximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks
Mayo Clinic
Scottsdale, Arizona, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Change in plasma oxalate
Efficacy will be assessed based on change from baseline in plasma oxalate
Time frame: on 12 weeks of treatment
Change in 24-hr urinary oxalate excretion
Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion
Time frame: on 12 weeks of treatment
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Mayo Clinic
Rochester, Minnesota, United States
Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin
Berlin, Germany
Wellcome Trust Clinical Research Facility
Southampton, Hampshire, United Kingdom
Royal Preston Hospital
Preston, Lancashire, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Freeman Hospital
Newcastle, United Kingdom