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RNAi Therapeutics
Lumasiran for Primary Hyperoxaluria (ILLUMINATE-C 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 documented diagnosis of primary hyperoxaluria type 1 (PH1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 60
Awards & highlights
ILLUMINATE-C Trial Summary
This trial will study how safe and effective the drug lumasiran is in treating patients with Advanced Primary Hyperoxaluria Type 1.
Who is the study for?
This trial is for patients with Advanced Primary Hyperoxaluria Type 1 (PH1). Eligible participants include those on stable hemodialysis for at least 4 weeks, diagnosed with PH1, meeting specific plasma oxalate levels, and if taking Vitamin B6, must have been on a consistent dose for over 90 days. Patients should have an eGFR ≤45 mL/min/1.73 m^2 or elevated serum creatinine for their age if under 12 months.Check my eligibility
What is being tested?
The study tests Lumasiran's effectiveness and safety in treating PH1. It will also examine 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 of Lumasiran may include reactions at the injection site, allergic responses, kidney-related issues due to changes in urine composition after treatment, and general discomforts such as headache or nausea.
ILLUMINATE-C Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with primary hyperoxaluria type 1.
ILLUMINATE-C Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to month 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort A: Percent Change in Plasma Oxalate From Baseline to Month 6
Cohort B: Percent Change in Pre-dialysis Plasma Oxalate From Baseline to Month 6
Secondary outcome measures
Absolute Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 60
Absolute Change in Plasma Oxalate From Baseline to Month 6
Absolute Change in Plasma Oxalate From Baseline to Month 60
+26 moreSide effects data
From 2024 Phase 3 trial • 39 Patients • NCT0368118423%
Injection site reaction
12%
Injection site pain
12%
Headache
12%
Injection site erythema
8%
Abdominal pain
8%
Abdominal pain upper
8%
Pneumonia
8%
Back pain
8%
Rhinitis
8%
Upper respiratory tract infection
8%
Urinary tract infection
4%
Abdominal discomfort
4%
Nasal congestion
4%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumasiran
Placebo
ILLUMINATE-C Trial Design
1Treatment groups
Experimental Treatment
Group I: LumasiranExperimental Treatment1 Intervention
All patients will receive open-label lumasiran.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumasiran
2016
Completed Phase 3
~120
Find a Location
Who is running the clinical trial?
Alnylam PharmaceuticalsLead Sponsor
72 Previous Clinical Trials
14,797 Total Patients Enrolled
3 Trials studying Primary Hyperoxaluria
38 Patients Enrolled for Primary Hyperoxaluria
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,777 Previous Clinical Trials
8,063,465 Total Patients Enrolled
3 Trials studying Primary Hyperoxaluria
38 Patients Enrolled for Primary Hyperoxaluria
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with primary hyperoxaluria type 1.I have kidney problems not caused by Primary Hyperoxaluria type 1.I have been on a stable hemodialysis regimen for at least 4 weeks.My kidney function is low, with an eGFR of 45 or less.I have had a kidney transplant and am on immunosuppressants.I have had a liver transplant.I have been taking Vitamin B6 regularly for at least 3 months.Your plasma oxalate levels are within the specified range.I am on dialysis, either hemodialysis with peritoneal or just peritoneal.
Research Study Groups:
This trial has the following groups:- Group 1: Lumasiran
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other existing research on Lumasiran?
"Currently, there are five clinical trials underway for Lumasiran. Three of those active trials are in Phase 3. The majority of the trials for Lumasiran are taking place in Haifa, but there are also 82 locations running trials for this treatment across Texas."
Answered by AI
What is the Lumasiran drug's official classification from the FDA?
"There is some prior clinical data supporting Lumasiran's efficacy and multiple rounds of safety testing have been completed, so it received a score of 3."
Answered by AI
How many patients will be given this experimental treatment?
"Currently, this clinical trial is not open for enrollment. It was first posted on 1/21/2020 and most recently updated on 11/7/2022. There are 7 other trials for primary hyperoxaluria and 5 for Lumasiran that are actively recruiting participants."
Answered by AI
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