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RNAi Therapeutics

Lumasiran for Primary Hyperoxaluria Type 1 (ILLUMINATE-B 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

Has genetic confirmation of primary hyperoxaluria type 1 (PH1)

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

ILLUMINATE-B Trial Summary

This trial will test if lumasiran can effectively and safely treat primary hyperoxaluria type 1 in young children.

Who is the study for?

This trial is for infants and young children who have a genetically confirmed diagnosis of primary hyperoxaluria type 1 (PH1) and meet specific urinary oxalate levels. They must be on a stable Vitamin B6 regimen if applicable. Children with severe kidney dysfunction, past organ transplants, systemic oxalosis, or very high creatinine levels cannot participate.Check my eligibility

What is being tested?

The study tests Lumasiran's effectiveness and safety in treating PH1 in young patients. It also examines how the body processes the drug (pharmacokinetics) and its impact on the disease (pharmacodynamics).See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions at injection sites, changes in liver enzymes, nausea, or other symptoms related to altering metabolism pathways affected by PH1.

ILLUMINATE-B Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been genetically diagnosed with primary hyperoxaluria type 1.

ILLUMINATE-B Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 6

Secondary outcome measures

Absolute Change in Plasma Oxalate From Baseline to End of Study (Month 60)

Absolute Change in Urinary Oxalate Excretion From Baseline

Apparent Clearance (CL/F) of Lumasiran

+11 more

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-B Trial Design

1Treatment groups

Experimental Treatment

Group I: LumasiranExperimental Treatment1 Intervention

Lumasiran will be administered by subcutaneous (SC) injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumasiran

2016

Completed Phase 3

~120

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor

72 Previous Clinical Trials

14,800 Total Patients Enrolled

3 Trials studying Primary Hyperoxaluria

41 Patients Enrolled for Primary Hyperoxaluria

Medical DirectorStudy DirectorAlnylam Pharmaceuticals

2,777 Previous Clinical Trials

8,063,462 Total Patients Enrolled

3 Trials studying Primary Hyperoxaluria

41 Patients Enrolled for Primary Hyperoxaluria

Media Library

Lumasiran (RNAi Therapeutics) Clinical Trial Eligibility Overview. Trial Name: NCT03905694 — Phase 3

Primary Hyperoxaluria Research Study Groups: Lumasiran

Primary Hyperoxaluria Clinical Trial 2023: Lumasiran Highlights & Side Effects. Trial Name: NCT03905694 — Phase 3

Lumasiran (RNAi Therapeutics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03905694 — Phase 3

Frequently Asked Questions

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

Who is the target audience for this clinical trial?

"Eligible patients for this study must be between 0 and 5 years old, have primary hyperoxaluria, and meet other requirements. Currently, the clinical trial is looking to enroll 18 patients in total."

Answered by AI

What is the efficacy of Lumasiran in light of other research?

"Currently, 5 Lumasiran trials are underway. 3 of these trials are in their final stage, Phase 3. Although the majority of these trials are based in Haifa, Israel, there are a total of 82 clinical trial locations for this treatment worldwide."

Answered by AI

Will elderly patients be able to enroll in this research project?

"This study is looking for children aged 0-5 to participate."

Answered by AI

What is the margin for error with Lumasiran?

"Lumasiran is classified as a Phase 3 trial drug, meaning that while there is some evidence of its efficacy, multiple rounds of data are needed to support its safety. Our team at Power rates Lumasiran's safety as a 3."

Answered by AI

How many individuals can join this test at most?

"As of October 14th, 2022, this study is no longer recruiting patients. it was initially posted on April 22nd, 2019. If you are looking for other studies, there are 7 clinical trials for primary hyperoxaluria and 5 for Lumasiran currently open for recruitment."

Answered by AI

What is unique about this particular clinical trial?

"5 clinical trials for Lumasiran are currently underway in cities across 15 countries. The first trial began in 2018 and, sponsored by Alnylam Pharmaceuticals, it involved 20 patients. The study completed its Phase 2 drug approval stage in 2018 and 1 study has been conducted since then."

Answered by AI

Recent research and studies

Genetics in MedicineJournal

Phase 3 Trial of Lumasiran for Primary Hyperoxaluria Type 1: A New Rnai Therapeutic in Infants and Young Children

Sas, David J., Daniella Magen, Wesley Hayes, Hadas Shasha-Lavsky, Mini Michael, Indra Schulte, Anne-Laure Sellier-Leclerc, et al.. 2022. “Phase 3 Trial of Lumasiran for Primary Hyperoxaluria Type 1: A New Rnai Therapeutic in Infants and Young Children”. Genetics in Medicine. Elsevier BV. doi:10.1016/j.gim.2021.10.024.

Pediatric NephrologyJournal

Efficacy and Safety of Lumasiran for Infants and Young Children with Primary Hyperoxaluria Type 1: 12-month Analysis of the Phase 3 ILLUMINATE-B Trial

Hayes, Wesley, David J. Sas, Daniella Magen, Hadas Shasha-Lavsky, Mini Michael, Anne-Laure Sellier-Leclerc, Julien Hogan, et al.. 2022. “Efficacy and Safety of Lumasiran for Infants and Young Children with Primary Hyperoxaluria Type 1: 12-month Analysis of the Phase 3 ILLUMINATE-B Trial”. Pediatric Nephrology. Springer Science and Business Media LLC. doi:10.1007/s00467-022-05684-1.

clinicaltrials.govStudy

A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1

2019. "A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03905694.