Clinical trial NCT05161936: A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent Calcium Oxalate Kidney Stone Disease
Elevated Urinary Oxalate Levels
Keywords: Calcium oxalate
Kidney stones
Elevated urinary oxalate
Urinary oxalate
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6
timeFrame: Baseline to Month 6
Secondary outcomes:
measure: Percentage of Patients Who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate From Baseline to Month 6
timeFrame: Baseline to Month 6
measure: Percent Change in Urinary Calcium Oxalate Supersaturation From Baseline to Month 6
timeFrame: Baseline to Month 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Trial Site
state: Alabama
city: Northridge
country: United States
facility: Clinical Trial Site
state: California
city: San Francisco
country: United States
facility: Clinical Trial Site
state: California
city: Hialeah
country: United States
facility: Clinical Trial Site
state: Florida
city: Acworth
country: United States
facility: Clinical Trial Site
state: Georgia
city: Quincy
country: United States
facility: Clinical Trial Site
state: Illinois
city: Carmel
country: United States
facility: Clinical Trial Site
state: Indiana
city: Boston
country: United States
facility: Clinical Trial Site
state: Massachusetts
city: Edina
country: United States
facility: Clinical Trial Site
state: Minnesota
city: Rochester
country: United States
facility: Clinical Trial Site
state: Minnesota
city: Las Vegas
country: United States
facility: Clinical Trial Site
state: Nevada
city: Albany
country: United States
facility: Clinical Trial Site
state: New York
city: Garden City
country: United States
facility: Clinical Trial Site
state: New York
city: Greensboro
country: United States
facility: Clinical Trial Site
state: North Carolina
city: North Charleston
country: United States
facility: Clinical Trial Site
state: South Carolina
city: El Paso
country: United States
facility: Clinical Trial Site
state: Texas
city: Houston
country: United States
facility: Clinical Trial Site
state: Texas
city: Brussels
country: Belgium
facility: Clinical Trial Site
city: Gent
country: Belgium
facility: Clinical Trial Site
city: Kortrijk
country: Belgium
facility: Clinical Trial Site
city: Liège
country: Belgium
facility: Clinical Trial Site
city: Bologna
country: Italy
facility: Clinical Trial Site
city: Pavia
country: Italy
facility: Clinical Trial Site
city: Rome
country: Italy
facility: Clinical Trial Site
city: Verona
country: Italy
facility: Clinical Trial Site
city: Madrid
country: Spain
facility: Clinical Trial Site
city: Bern
country: Switzerland
facility: Clinical Trial Site
city: Lausanne
country: Switzerland
facility: Clinical Trial Site
city: Zürich
country: Switzerland
facility: Clinical Trial Site
city: Doncaster
country: United Kingdom
facility: Clinical Trial Site
city: Leeds
country: United Kingdom
facility: Clinical Trial Site
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References: