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

Phase 2

Terminated

• Conditions: Recurrent Calcium Oxalate Kidney Stone Disease; Elevated Urinary Oxalate Levels
• Interventions: Drug: Placebo; Drug: Lumasiran

• Registration Number: NCT05161936
• Lead Sponsor: Alnylam Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-17
• Study Start: 2022-01-27
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Results First Submitted: 2024-02-11
• Status Verified: 2024-04
• Results First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Results First Posted: 2024-05-22
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will be administered placebo by SC injection.
Lumasiran Dose 2	Lumasiran	Participants will be administered lumasiran by SC injection.
Lumasiran Dose 1	Lumasiran	Participants will be administered lumasiran by subcutaneous (SC) injection.

Primary Outcome Measures

Name	Time	Method
Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6	Baseline to Month 6

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate From Baseline to Month 6	Baseline to Month 6
Percent Change in Urinary Calcium Oxalate Supersaturation From Baseline to Month 6	Baseline to Month 6

Trial Locations

Locations (1)

Clinical Trial Site; 🇬🇧 Leeds, United Kingdom