Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official 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

Keywords

Recurrent Calcium Oxalate Kidney Stone Disease, Elevated Urinary Oxalate Levels, Calcium oxalate, Kidney stones, Elevated urinary oxalate, Urinary oxalate, Kidney Calculi, Nephrolithiasis, Recurrence, Calculi, Lumasiran

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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/1.73m2 at screening

  • Received an investigational agent within the last 30 days or 5 half-lives, whichever is longer

Locations

  • Clinical Trial Site accepting new patients
    San Francisco California 94143 United States
  • Clinical Trial Site accepting new patients
    Northridge California 91324 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alnylam Pharmaceuticals
ID
NCT05161936
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated