Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Former… (NCT02289755) | Clinical Trial Compass
CompletedPhase 2
Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
United States16 participantsStarted 2014-09
Plain-language 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.
Who can participate
SexALL
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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
What they're measuring
1
Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion