A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Recurrent Calcium Oxalate Kidney Stone Disease, Elevated Urinary Oxalate Levels

In brief

The primary purpose of this study is to evaluate the effect of lumasiran on the percent change in urinary oxalate excretion in patients with recurrent calcium oxalate kidney stone disease.

Key facts

Study ID

NCT05161936

Run by

Alnylam Pharmaceuticals

People needed

2

Starts

2022-01-27

Expected to finish

2022-11-01

Last updated by the study team

2024-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of recurrent kidney stone disease based on ≥2 stone events with a minimum of 1 stone event within 5 years prior to screening
• Meets the 24 hour urine oxalate excretion requirements
• The 2 most recently analyzed kidney stones prior to randomization contained 50% or more of calcium oxalate; if only one stone analysis is available, then it must have contained 50% or more of calcium oxalate

You may not qualify if…

• Known history of secondary causes of elevated urinary oxalate and/or recurrent kidney stones
• Primary hyperoxaluria
• Estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m\^2 at screening
• Received an investigational agent within the last 30 days or 5 half-lives, whichever is longer

Where it is running

• Clinical Trial Site — Birmingham, Alabama, United States
• Clinical Trial Site — Northridge, California, United States
• Clinical Trial Site — San Francisco, California, United States
• Clinical Trial Site — Hialeah, Florida, United States
• Clinical Trial Site — Acworth, Georgia, United States
• Clinical Trial Site — Quincy, Illinois, United States
• Clinical Trial Site — Carmel, Indiana, United States
• Clinical Trial Site — Boston, Massachusetts, United States
• Clinical Trial Site — Edina, Minnesota, United States
• Clinical Trial Site — Rochester, Minnesota, United States
• Clinical Trial Site — Las Vegas, Nevada, United States
• Clinical Trial Site — Albany, New York, United States
• Clinical Trial Site — Garden City, New York, United States
• Clinical Trial Site — Greensboro, North Carolina, United States
• Clinical Trial Site — North Charleston, South Carolina, United States
• Clinical Trial Site — El Paso, Texas, United States
• Clinical Trial Site — Houston, Texas, United States
• Clinical Trial Site — Brussels, Belgium
• Clinical Trial Site — Ghent, Belgium
• Clinical Trial Site — Kortrijk, Belgium
• Clinical Trial Site — Liège, Belgium
• Clinical Trial Site — Bologna, Italy
• Clinical Trial Site — Pavia, Italy
• Clinical Trial Site — Rome, Italy
• Clinical Trial Site — Verona, Italy

Full record on ClinicalTrials.gov

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