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RNAi Therapeutics

Lumasiran for Primary Hyperoxaluria Type 1 (ILLUMINATE-A Trial)

Phase 3

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 2, months 1, 2, 3, 4, 5 and 6

Awards & highlights

ILLUMINATE-A Trial Summary

This trial will test if lumasiran can improve PH1 symptoms and is safe for children and adults.

Who is the study for?

This trial is for children and adults with Primary Hyperoxaluria Type 1. Participants must be willing to follow study rules, have specific urine oxalate levels, and if on Vitamin B6, they need a stable dose for 90 days. They can't join if they have severe kidney issues, significant health problems besides PH1, recent alcohol abuse, are pregnant or not using contraception, or have HIV/hepatitis.Check my eligibility

What is being tested?

The trial is testing Lumasiran's effectiveness and safety against a placebo in treating Primary Hyperoxaluria Type 1. Patients will either receive the actual drug Lumasiran or a placebo without active ingredients to compare outcomes.See study design

What are the potential side effects?

Possible side effects of Lumasiran may include reactions at the injection site like redness or pain, potential allergic responses due to its oligonucleotide content (a type of genetic material), and other unspecified risks that typically accompany new medications.

ILLUMINATE-A Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 2, months 1, 2, 3, 4, 5 and 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 2, months 1, 2, 3, 4, 5 and 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, months 1, 2, 3, 4, 5 and 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 Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 6

Secondary outcome measures

Absolute Change in 24-hour Urinary Oxalate Corrected for BSA From Baseline to Month 6

Absolute Change in 24-hour Urinary Oxalate Excretion From Baseline Over Time During the Extension Period

Absolute Change in Plasma Oxalate From Baseline to Month 6

+9 more

Other outcome measures

Change From Baseline in Nephrocalcinosis as Assessed by Renal Ultrasound

Rate of Renal Stone Events

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

ILLUMINATE-A Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LumasiranExperimental Treatment2 Interventions

Lumasiran was administered SC, 3.0 mg/kg, at Day 1 and Months 1, 2 and 3 during the 6-Month DB Period, followed by lumasiran SC, 3.0 mg/kg at Month 6, and lumasiran-matching placebo SC at Months 7 and 8 during the 3-Month Blinded Treatment Extension Period, followed by lumasiran SC, 3.0 mg/kg, at Month 9 and then every three months during the 51-Month OLE period.

Group II: PlaceboPlacebo Group2 Interventions

Lumasiran-matching placebo (normal saline [0.9% NaCl]) was administered subcutaneously (SC) at Day 1 and Months 1, 2 and 3 during the 6-Month Double-blind (DB) Period, followed by lumasiran SC, 3.0 mg/kg, at Months 6, 7 and 8 during the 3-Month Blinded Treatment Extension Period, followed by lumasiran SC, 3.0 mg/kg, at Month 9 and then every three months during the 51-Month Open-label Extension (OLE) period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Lumasiran

2016

Completed Phase 3

~120

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor

72 Previous Clinical Trials

14,779 Total Patients Enrolled

4 Trials studying Primary Hyperoxaluria

59 Patients Enrolled for Primary Hyperoxaluria

Medical DirectorStudy DirectorAlnylam Pharmaceuticals

2,777 Previous Clinical Trials

8,063,825 Total Patients Enrolled

4 Trials studying Primary Hyperoxaluria

59 Patients Enrolled for Primary Hyperoxaluria

Frequently Asked Questions

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

How many people total are enrolled in this clinical trial?

"This study is not enrolling new patients at the moment, although this may change in the future. According to the latest update on October 14th 2022, 7 other studies are actively searching for participants with primary oxalosis and 5 studies are looking for patients that fit the Lumasiran criteria."

Answered by AI

What is the legal status of Lumasiran in the United States?

"Lumasiran's safety is estimated to be a 3. This score comes from the fact that Lumasiran is in Phase 3 of clinical trials, which suggests that there is both some efficacy data and multiple rounds of safety data supporting its use."

Answered by AI

Do we have any previous data to support the use of Lumasiran?

"As of right now, there are 5 ongoing clinical trials for Lumasiran. 3 of those trials have reached Phase 3. Most of the research is being conducted in Haifa, however there are 82 total locations running these tests."

Answered by AI

Are there any available vacancies for this clinical trial?

"Right now, this clinical trial is not searching for any participants. Although, it was first posted on 27th November 2018 and most recently updated on the 14th of October in 2022. There are other trials though! 7 studies are currently looking for patients with primary oxalosis while 5 different research teams are admitting patients for Lumasiran treatment."

Answered by AI

If this study is successful, will it be adopted by other hospitals in the state?

"Right now, this trial is looking for participants from 5 different enrolment sites. Two of these are in Rochester and San Diego, with the other 3 located elsewhere. If you're interested in enrolling, it might be best to choose a location near to you so that travel isn't too much of an issue."

Answered by AI

Have researchers tried anything like this before?

"Since 2018, Lumasiran has been under clinical investigation in 5 separate trials. The first of these was sponsored by Alnylam Pharmaceuticals and took place in 2018 with 20 participants. Phase 2 approval was granted after the successful completion of this trial. Currently, the drug is being studied in 22 cities across 15 countries."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Lumasiran, an Rnai Therapeutic for Primary Hyperoxaluria Type 1

Garrelfs, Sander F., Yaacov Frishberg, Sally A. Hulton, Michael J. Koren, William D. O’Riordan, Pierre Cochat, Georges Deschênes, et al.. 2021. “Lumasiran, an Rnai Therapeutic for Primary Hyperoxaluria Type 1”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2021712.

clinicaltrials.govStudy

A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1

2018. "A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03681184.