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

Completed · Phase 2

Conditions studied: Hyperoxaluria, Nephrolithiasis

In brief

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.

Key facts

Study ID

NCT02289755

Run by

Allena Pharmaceuticals

People needed

16

Starts

2014-09-01

Expected to finish

2015-02-01

Last updated by the study team

2019-06-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana University Physicians Urology — Indianapolis, Indiana, United States
• North Shore Long Island Jewish Health System — Lake Success, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Omega Clinical Research — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

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