ILLUMINATE-C Study 6-Month Primary Analysis Results

American Nephrology Nurses Association 2022 National Symposium

ILLUMINATE-C was a single-arm, phase 3 study examining lumasiran, an RNA interference (RNAi) therapeutic. The agent inhibits oxalate production in patients with primary hyperoxaluria type 1 (PH1) and impaired kidney function.

At the ANNA 2022 National Symposium, Philip Arnold, MSN, RN, and colleagues presented 6-month primary analysis ILLUMINATE-C data in a session titled ILLUMINATE-C, a Single-Arm, Phase 3 Study of Lumasiran in Patients with Primary Hyperoxaluria Type 1 and CKD 3b-5, including Those on Hemodialysis.

Inclusion criteria were genetically confirmed PH1 diagnosis, estimated glomerular filtration rate ≤45 mL/min/1.73 m2, and plasma oxalate (POx) ≥20 mmol/L (upper limit of normal = 12 mmol). Patients who did not require dialysis or kidney transplantation at the start of the study were cohort A (n=6) and patients receiving hemodialysis were cohort B (n=15). The primary end points of interest were percent change in POx from baseline to month 6 (cohort A) and percent change in predialysis POx from baseline to month 6 (cohort B).

Baseline mean POx was 64.7 mmol/L in cohort A and 108.4 mmol/L in cohort B. Lumasiran led to 33.33% (95% CI –15.16% to 81.82%) least-square mean reduction in POx from baseline to month 6 (averaged across months 3-6) in cohort A and 42.43% least-square mean reduction (95% CI, 34.15% to 50.781%0 in cohort B.

The most common adverse events related to the study drug were injection-site reactions (all mild).

In summary, the authors said, “Lumasiran resulted in substantial reductions in POx in PH1 patients with CKD 3b-5, with an acceptable safety profile through month 6.”

Source: Arnold P, Michael M, Groothoff J, et al. ILLUMINATE-C, a single-arm, phase 3 study of lumasiran in patients with primary hyperoxaluria type 1 and CKD 3b-5, including those on hemodialysis. Abstract of a presentation at the American Nephrology Nurses Association 2022 National Symposium, Fort Worth, Texas, May 22-25, 2022.