Back to resultsA Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
Primary Purpose
Recurrent Calcium Oxalate Kidney Stone Disease, Elevated Urinary Oxalate Levels
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lumasiran
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Calcium Oxalate Kidney Stone Disease focused on measuring Calcium oxalate, Kidney stones, Elevated urinary oxalate, Urinary oxalate
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Lumasiran Dose 1
Lumasiran Dose 2
Placebo
Arm Description
Participants will be administered lumasiran by subcutaneous (SC) injection.
Participants will be administered lumasiran by SC injection.
Participants will be administered placebo by SC injection.
Outcomes
Primary Outcome Measures
Percent Change in 24-hour Urinary Oxalate from Baseline to Month 6
Secondary Outcome Measures
Percentage of Patients who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate from Baseline to Month 6
Percent Change in Urinary Calcium Oxalate Supersaturation from Baseline to Month 6
Full Information
NCT ID
NCT05161936
First Posted
December 8, 2021
Last Updated
March 20, 2023
Sponsor
Alnylam Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05161936
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early due to low enrollment
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
January 18, 2023 (Actual)
Study Completion Date
January 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alnylam Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Calcium Oxalate Kidney Stone Disease, Elevated Urinary Oxalate Levels
Keywords
Calcium oxalate, Kidney stones, Elevated urinary oxalate, Urinary oxalate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumasiran Dose 1
Arm Type
Experimental
Arm Description
Participants will be administered lumasiran by subcutaneous (SC) injection.
Arm Title
Lumasiran Dose 2
Arm Type
Experimental
Arm Description
Participants will be administered lumasiran by SC injection.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be administered placebo by SC injection.
Intervention Type
Drug
Intervention Name(s)
Lumasiran
Other Intervention Name(s)
OXLUMO, ALN-GO1
Intervention Description
Lumasiran will be administered by SC injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered by SC injection.
Primary Outcome Measure Information:
Title
Percent Change in 24-hour Urinary Oxalate from Baseline to Month 6
Time Frame
Baseline to Month 6
Secondary Outcome Measure Information:
Title
Percentage of Patients who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate from Baseline to Month 6
Time Frame
Baseline to Month 6
Title
Percent Change in Urinary Calcium Oxalate Supersaturation from Baseline to Month 6
Time Frame
Baseline to Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Alnylam Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Clinical Trial Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Clinical Trial Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Clinical Trial Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Clinical Trial Site
City
Acworth
State/Province
Georgia
ZIP/Postal Code
30101
Country
United States
Facility Name
Clinical Trial Site
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Clinical Trial Site
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Clinical Trial Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Clinical Trial Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Clinical Trial Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Clinical Trial Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Clinical Trial Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Clinical Trial Site
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Clinical Trial Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Clinical Trial Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Clinical Trial Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Clinical Trial Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Clinical Trial Site
City
Brussels
Country
Belgium
Facility Name
Clinical Trial Site
City
Gent
Country
Belgium
Facility Name
Clinical Trial Site
City
Kortrijk
Country
Belgium
Facility Name
Clinical Trial Site
City
Liège
Country
Belgium
Facility Name
Clinical Trial Site
City
Bologna
Country
Italy
Facility Name
Clinical Trial Site
City
Pavia
Country
Italy
Facility Name
Clinical Trial Site
City
Rome
Country
Italy
Facility Name
Clinical Trial Site
City
Verona
Country
Italy
Facility Name
Clinical Trial Site
City
Madrid
Country
Spain
Facility Name
Clinical Trial Site
City
Bern
Country
Switzerland
Facility Name
Clinical Trial Site
City
Lausanne
Country
Switzerland
Facility Name
Clinical Trial Site
City
Zürich
Country
Switzerland
Facility Name
Clinical Trial Site
City
Doncaster
Country
United Kingdom
Facility Name
Clinical Trial Site
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
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