About the ILLUMINATE-C PH1 Clinical Trial

ILLUMINATE-C is an open-label study to evaluate the safety and effectiveness of lumasiran (ALN-GO1) in people with Advanced Primary Hyperoxaluria Type 1 (PH1) patients both on and off dialysis.

This study will include 2 cohorts (groups):

  • Cohort A: Non-dialysis patients
  • Cohort B: Dialysis-dependent patients

If dialysis is initiated after joining the study, participation can continue. Patients from cohort A can cross to cohort B if dialysis is initiated after joining the study.

Who is eligible for the ILLUMINATE-C clinical trial?

ILLUMINATE-C is enrolling participants of all ages who have a PH1 diagnosis as determined by genetic testing.

What is the purpose of ILLUMINATE-C?

ILLUMINATE-C is an open label* study evaluating the safety and effectiveness of the investigational medicine lumasiran on oxalate overproduction in people with PH1. 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 and kidney disease in people 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-C?

The ILLUMINATE-C study is planning to enroll approximately 16 participants for a 5-year study participation commitment. 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-C study is not for people with PH1 who:

  • Are on peritoneal dialysis
  • Have had a liver transplant
  • Are pregnant or planning to become pregnant during the study
  • Are unwilling to limit their alcohol use if directed by the study team

Clinical trials don’t have to be confusing.

Visit our “Understanding Clinical Research” page for definitions and explanations.