Status:
COMPLETED
Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
Lead Sponsor:
Allena Pharmaceuticals
Conditions:
Hyperoxaluria
Nephrolithiasis
Eligibility:
All Genders
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02289755
Start Date
September 1 2014
End Date
February 1 2015
Last Update
June 5 2019
Active Locations (4)
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1
Indiana University Physicians Urology
Indianapolis, Indiana, United States, 46202
2
North Shore Long Island Jewish Health System
Lake Success, New York, United States, 11042
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
Omega Clinical Research
Warwick, Rhode Island, United States, 02886