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

NCT05161936 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ALN-GO1-008
• Study Type: interventional
• Target: 2
• Locations: 6 countries
• Sites: 31

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.

Conditions

Recurrent Calcium Oxalate Kidney Stone Disease; Elevated Urinary Oxalate Levels

Keywords

Calcium oxalate; Kidney stones; Elevated urinary oxalate; Urinary oxalate

Outcome Measures

Primary Outcomes (1)

• Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6

  Baseline to Month 6

Secondary Outcomes (2)

• 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

Study Arms (3)

Lumasiran Dose 1

EXPERIMENTAL

Participants will be administered lumasiran by subcutaneous (SC) injection.

Drug: Lumasiran

Lumasiran Dose 2

EXPERIMENTAL

Participants will be administered lumasiran by SC injection.

Drug: Lumasiran

Placebo

PLACEBO COMPARATOR

Participants will be administered placebo by SC injection.

Drug: Placebo

Interventions

Lumasiran DRUG

Lumasiran will be administered by SC injection.

Also known as: OXLUMO, ALN-GO1

Lumasiran Dose 1; Lumasiran Dose 2

Placebo DRUG

Placebo will be administered by SC injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alnylam Pharmaceuticals: lead

Study Sites (31)

Clinical Trial Site

Birmingham, Alabama, 35233, United States

Location

Clinical Trial Site

Northridge, California, 91324, United States

Location

Clinical Trial Site

San Francisco, California, 94143, United States

Location

Clinical Trial Site

Hialeah, Florida, 33016, United States

Location

Clinical Trial Site

Acworth, Georgia, 30101, United States

Location

Clinical Trial Site

Quincy, Illinois, 62301, United States

Location

Clinical Trial Site

Carmel, Indiana, 46032, United States

Location

Clinical Trial Site

Boston, Massachusetts, 02114, United States

Location

Clinical Trial Site

Edina, Minnesota, 55435, United States

Location

Clinical Trial Site

Rochester, Minnesota, 55905, United States

Location

Clinical Trial Site

Las Vegas, Nevada, 89128, United States

Location

Clinical Trial Site

Albany, New York, 12208, United States

Location

Clinical Trial Site

Garden City, New York, 11530, United States

Location

Clinical Trial Site

Greensboro, North Carolina, 27403, United States

Location

Clinical Trial Site

North Charleston, South Carolina, 29405, United States

Location

Clinical Trial Site

El Paso, Texas, 79902, United States

Location

Clinical Trial Site

Houston, Texas, 77054, United States

Location

Clinical Trial Site

Brussels, Belgium

Location

Clinical Trial Site

Ghent, Belgium

Location

Clinical Trial Site

Kortrijk, Belgium

Location

Clinical Trial Site

Liège, Belgium

Location

Clinical Trial Site

Bologna, Italy

Location

Clinical Trial Site

Pavia, Italy

Location

Clinical Trial Site

Rome, Italy

Location

Clinical Trial Site

Verona, Italy

Location

Clinical Trial Site

Madrid, Spain

Location

Clinical Trial Site

Bern, Switzerland

Location

Clinical Trial Site

Lausanne, Switzerland

Location

Clinical Trial Site

Zurich, Switzerland

Location

Clinical Trial Site

Doncaster, United Kingdom

Location

Clinical Trial Site

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

lumasiran

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Alnylam Pharmaceuticals Inc.

Clinicaltrials@alnylam.com

866-330-0326

Study Officials

• Medical Director

  Alnylam Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 17, 2021
• Study Start: January 27, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4); US (17); BE (4); ES (1); CH (3); GB (2)