About the ILLUMINATE-B PH1 Pediatric Clinical Trial
ILLUMINATE-B is a clinical study investigating the safety and effectiveness of the investigational medicine lumasiran (ALN-GO1) in reducing urinary oxalate excretion (the amount of oxalate found in the urine) in infants and young children with PH1.
ILLUMINATE-B has completed enrollment. Please sign up to be notified about future Alnylam PH1 clinical studies.
Who is eligible for the ILLUMINATE-B clinical trial?
Children and infants under 6 years of age at screening who have a confirmed PH1 diagnosis as determined by genetic testing may be eligible for this clinical trial.
What is the purpose of ILLUMINATE-B?
ILLUMINATE-B is an open-label* pediatric study to study the safety and effectiveness of lumasiran (ALN-GO1) in young children with primary hyperoxaluria type 1. That means that without testing against a placebo, we’re studying how safe and effective lumasiran is at reducing oxalate overproduction, which often results in painful, recurring kidney stones in infants and young children with Primary Hyperoxaluria Type 1 (PH1). *See our “About Clinical Trials” page for definitions of these and other study-related terms.
What happens in ILLUMINATE-B?
The ILLUMINATE-B study is planning to enroll approximately 8 pediatric participants for a study participation commitment of up to 5 years. Throughout the trial, study participants will be required to attend study visits and provide blood and urine samples. All participants will receive lumasiran and no participants will receive placebo.
Who is not eligible?
The ILLUMINATE-B study is not for people with PH1 who:
Have systemic oxalosis (oxalate is in organs outside the kidney)
Have had a kidney or liver transplant
Are on dialysis
Other criteria will be assessed to determine eligibility.