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RNAi Therapeutics

Lumasiran for Kidney Stone Disease

Phase 2

Waitlist Available

Research Sponsored by Alnylam Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 6

Awards & highlights

Study Summary

This trial will study whether lumasiran, a drug that lowers oxalate levels, can help prevent calcium oxalate kidney stones from recurring.

Eligible Conditions

Calcium Oxalate Kidney Stone Disease
Hyperoxaluria

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Percent Change in Urinary Calcium Oxalate Supersaturation from Baseline to Month 6

Percentage of Patients who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate from Baseline to Month 6

Side effects data

From 2024 Phase 3 trial • 39 Patients • NCT03681184

23%

Injection site reaction

12%

Injection site pain

12%

Headache

12%

Injection site erythema

Abdominal pain

Abdominal pain upper

Pneumonia

Back pain

Rhinitis

Upper respiratory tract infection

Urinary tract infection

Abdominal discomfort

Nasal congestion

Oropharyngeal pain

100%

80%

60%

40%

20%

Study treatment Arm

Lumasiran

Placebo

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Lumasiran Dose 2Experimental Treatment1 Intervention

Participants will be administered lumasiran by SC injection.

Group II: Lumasiran Dose 1Experimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

Participants will be administered placebo by SC injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumasiran

2016

Completed Phase 3

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor

72 Previous Clinical Trials

14,816 Total Patients Enrolled

Medical DirectorStudy DirectorAlnylam Pharmaceuticals

2,777 Previous Clinical Trials

8,063,484 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial being conducted at more than one location in America?

"This study is being conducted at 18 hospitals, which are situated in cities such as San Francisco, Birmingham and Houston. You can pick the location that is closest to you when enrolling to cut down on travel time."

Answered by AI

Does this clinical trial break new ground?

"The development of Lumasiran began in 2018 with an initial study that Alnylam Pharmaceuticals sponsored. 20 patients were enrolled in this first trial which concluded that year and led to the drug's Phase 2 approval. Now, 5 clinical studies are underway across 15 different nations."

Answered by AI

How many study participants are needed for this research project?

"Yes, the latest information on clinicaltrials.gov indicates that this study is still recruiting patients. The trial was initially posted on 1/27/2022 and was last updated on 10/14/2022. The study needs to recruit 120 patients from 18 different sites."

Answered by AI

What other drugs has Lumasiran been tested against in previous studies?

"Lumasiran was first studied in 2018 at a clinical trial site. Since then, there have been 18290 completed studies. Presently, there are 5 active clinical trials taking place with many of them located in San Francisco and Alabama."

Answered by AI

Has the Lumasiran drug been cleared for public use by the FDA?

"Lumasiran's safety was given a score of 2. This is because, although there is some evidence supporting its safety profile, none exists yet for the efficacy of Lumasiran."

Answered by AI

Are we still able to enroll people in this experiment?

"Yes, the trial is still ongoing and looking for new participants. The clinicaltrials.gov website shows that the study was first posted on 1/27/2022 and edited as recently as 10/14/2022. There are 18 different sites recruiting patients, with a goal of 120 total participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05161936.