Title
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
Phase
Phase 2Lead Sponsor
Allena PharmaceuticalsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Hyperoxaluria NephrolithiasisIntervention/Treatment
alln-177 ...Study Participants
16The 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.
ALLN-177 is orally administered oxalate decarboxylase (OxDc). The goal of oral therapy with ALLN-177 is to enzymatically degrade both dietary oxalate and endogenously produced oxalate secreted in the gastrointestinal tract resulting in decreased absorption and reduced urinary oxalate excretion.
Recurrent Calcium Oxalate Stone Formers with Hyperoxaluria Subjects with Enteric or Idiopathic hyperoxaluria Dosing: 5 capsules of ALLN-177 orally (p.o.) up to 3 times daily (TID) with meals for 4 consecutive days.
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
| Event Type | Organ System | Event Term | ALLN-177 |
|---|
Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).
Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100%
