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

Study Overview
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Brief Summary
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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
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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

Conditions
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Recurrent Calcium Oxalate Kidney Stone Disease, Elevated Urinary Oxalate Levels

Intervention / Treatment
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* Drug: Lumasiran
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumasiran Dose 1<br>Participants will be administered lumasiran by subcutaneous (SC) injection. | Drug: Lumasiran<br>* Lumasiran will be administered by SC injection.<br>* Other names: ALN-GO1;|
| Experimental: Lumasiran Dose 2<br>Participants will be administered lumasiran by SC injection. | Drug: Lumasiran<br>* Lumasiran will be administered by SC injection.<br>* Other names: ALN-GO1;|
| Placebo Comparator: Placebo<br>Participants will be administered placebo by SC injection. | Drug: Placebo<br>* Placebo will be administered by SC injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in 24-hour Urinary Oxalate from Baseline to Month 6 |  | Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcium oxalate, Kidney stones, Elevated urinary oxalate, Urinary oxalate