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

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

Inclusion Criteria:

• Documented diagnosis of recurrent kidney stone disease based on ≥2 stone events 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

Exclusion Criteria:

• 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