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

May 20, 2024 updated by: Alnylam Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Clinical Trial Site
      • Gent, Belgium
        • Clinical Trial Site
      • Kortrijk, Belgium
        • Clinical Trial Site
      • Liège, Belgium
        • Clinical Trial Site
  • Italy
      • Bologna, Italy
        • Clinical Trial Site
      • Pavia, Italy
        • Clinical Trial Site
      • Rome, Italy
        • Clinical Trial Site
      • Verona, Italy
        • Clinical Trial Site
  • Spain
      • Madrid, Spain
        • Clinical Trial Site
  • Switzerland
      • Bern, Switzerland
        • Clinical Trial Site
      • Lausanne, Switzerland
        • Clinical Trial Site
      • Zürich, Switzerland
        • Clinical Trial Site
  • United Kingdom
      • Doncaster, United Kingdom
        • Clinical Trial Site
      • Leeds, United Kingdom
        • Clinical Trial Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Clinical Trial Site
    • California
      • Northridge, California, United States, 91324
        • Clinical Trial Site
      • San Francisco, California, United States, 94143
        • Clinical Trial Site
    • Florida
      • Hialeah, Florida, United States, 33016
        • Clinical Trial Site
    • Georgia
      • Acworth, Georgia, United States, 30101
        • Clinical Trial Site
    • Illinois
      • Quincy, Illinois, United States, 62301
        • Clinical Trial Site
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Clinical Trial Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Clinical Trial Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Clinical Trial Site
      • Rochester, Minnesota, United States, 55905
        • Clinical Trial Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Clinical Trial Site
    • New York
      • Albany, New York, United States, 12208
        • Clinical Trial Site
      • Garden City, New York, United States, 11530
        • Clinical Trial Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Clinical Trial Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Clinical Trial Site
    • Texas
      • El Paso, Texas, United States, 79902
        • Clinical Trial Site
      • Houston, Texas, United States, 77054
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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:
  • ALN-GO1
  • OXLUMO
Experimental: Lumasiran Dose 2
Participants will be administered lumasiran by SC injection.
Drug: Lumasiran
Lumasiran will be administered by SC injection.
Other Names:
  • ALN-GO1
  • OXLUMO
Placebo Comparator: Placebo
Participants will be administered placebo by SC injection.
Drug: Placebo
Placebo will be administered by SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6
Time Frame: Baseline to Month 6
Baseline to Month 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alnylam Pharmaceuticals

Investigators

  • Study Director: Medical Director, Alnylam Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2022

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALN-GO1-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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