An evaluaNCT05161936tion of Lumasiran in Kidney Stone Disease and Hyperoxaluria
Research type
Research Study
Full title
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.
IRAS ID
1004301
Contact name
N/A Central Trial Information Line
Contact email
Sponsor organisation
Alnylam Pharmaceuticals, Inc.
Eudract number
2021-001519-10
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for an effective treatment option for patients with recurrent calcium oxalate kidney stone disease. Our research has shown that lumasiran, an investigational drug, blocks the production of a protein in the liver called glucoloate glycolate oxidase (GO), which reduces liver oxalate production. People with recurrent calcium oxalate kidney stone disease may have high levels of urinary oxalate which can lead to kidney stone formation. The purpose of this study is to determine whether lumasiran can lower the amount of oxalate in the urine of people with recurrent calcium oxalate kidney stone disease and make it less likely for them to have a kidney stone.
Approximately 120 participants will take part worldwide. Every participant in this study will be randomised to one of three treatment groups: lumasiran high dose, lumasiran low dose, or placebo. A placebo looks like a medicine but does not have any medicine in it.
The study will include a screening period for up to 2 months and a treatment period for 15 months. Participants will receive 3 doses of lumasiran or placebo, on day 1, month 3 and month 9. The study will last up to 17 months in total with 10 study visits. Participants have the option of off-site or home study visits.
The study is funded by Alnylam Pharmaceuticals, Inc.
REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0911
Date of REC Opinion
24 Jan 2022
REC opinion
Further Information Favourable Opinion