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

Phase 2

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ALLN-177	ALLN-177	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion	7 days	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).

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion	7 days	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%

Locations (4): Omega Clinical Research
🇺🇸
Warwick, Rhode Island, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Indiana University Physicians Urology
🇺🇸
Indianapolis, Indiana, United States
North Shore Long Island Jewish Health System
🇺🇸
Lake Success, New York, United States