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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05161936
Recruitment Status : Recruiting
First Posted : December 17, 2021
Last Update Posted : June 16, 2022
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Calcium Oxalate Kidney Stone Disease Elevated Urinary Oxalate Levels Drug: Lumasiran Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 27, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Lumasiran

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lumasiran Dose 1
Participants will be administered lumasiran by subcutaneous (SC) injection.
 Drug: Lumasiran
Lumasiran will be administered by SC injection.
Other Names:
  • OXLUMO
  • ALN-GO1
Experimental: Lumasiran Dose 2
Participants will be administered lumasiran by SC injection.
 Drug: Lumasiran
Lumasiran will be administered by SC injection.
Other Names:
  • OXLUMO
  • ALN-GO1
Placebo Comparator: Placebo
Participants will be administered placebo by SC injection.
 Drug: Placebo
Placebo will be administered by SC injection.


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change in 24-hour Urinary Oxalate from Baseline to Month 6 [ Time Frame: Baseline to Month 6 ]

Secondary Outcome Measures :
  1. Percentage of Patients who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate from Baseline to Month 6 [ Time Frame: Baseline to Month 6 ]
  2. Percent Change in Urinary Calcium Oxalate Supersaturation from Baseline to Month 6 [ Time Frame: Baseline to Month 6 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of recurrent kidney stone disease based on ≥2 stone events 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05161936


Contacts
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Contact: Alnylam Clinical Trial Information Line 1-877-ALNYLAM clinicaltrials@alnylam.com
Contact: Alnylam Clinical Trial Information Line 1-877-256-9526 clinicaltrials@alnylam.com

Locations
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United States, California
Clinical Trial Site Recruiting
Northridge, California, United States, 91324
United States, Florida
Clinical Trial Site Recruiting
Hialeah, Florida, United States, 33016
United States, Illinois
Clinical Trial Site Recruiting
Champaign, Illinois, United States, 61822
Clinical Trial Site Recruiting
Quincy, Illinois, United States, 62301
United States, Indiana
Clinical Trial Site Recruiting
Carmel, Indiana, United States, 46032
United States, Minnesota
Clinical Trial Site Recruiting
Edina, Minnesota, United States, 55435
United States, Nevada
Clinical Trial Site Recruiting
Las Vegas, Nevada, United States, 89128
United States, New York
Clinical Trial Site Recruiting
Albany, New York, United States, 12208
Clinical Trial Site Recruiting
Garden City, New York, United States, 11530
United States, North Carolina
Clinical Trial Site Recruiting
Greensboro, North Carolina, United States, 27403
United States, South Carolina
Clinical Trial Site Recruiting
North Charleston, South Carolina, United States, 29405
Belgium
Clinical Trial Site Recruiting
Gent, Belgium
Clinical Trial Site Recruiting
Liège, Belgium
Italy
Clinical Trial Site Recruiting
Bologna, Italy
Clinical Trial Site Recruiting
Pavia, Italy
Clinical Trial Site Recruiting
Rome, Italy
United Kingdom
Clinical Trial Site Recruiting
Leeds, United Kingdom
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
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Study Director: Medical Director Alnylam Pharmaceuticals
More Information
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Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05161936    
Other Study ID Numbers: ALN-GO1-008
First Posted: December 17, 2021    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alnylam Pharmaceuticals:
Calcium oxalate
Kidney stones
Elevated urinary oxalate
Urinary oxalate
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
 Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi