NCT05161936

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

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Lumasiran in Patients With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Calcium Oxalate Kidney Stone Disease
• Elevated Urinary Oxalate Levels

Interventions

Type	Name	Description
DRUG	Lumasiran	Lumasiran will be administered by SC injection.
DRUG	Placebo	Placebo will be administered by SC injection.

Timeline

• Start date: 2022-01-27
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2021-12-17
• Last updated: 2024-05-22
• Results posted: 2024-05-22

Locations

31 sites across 6 countries: United States, Belgium, Italy, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study