NCT04152200

A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1

ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 (PH1)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).

Conditions

• Primary Hyperoxaluria Type 1
• Primary Hyperoxaluria

Interventions

Type	Name	Description
DRUG	Lumasiran	Lumasiran will be administered by subcutaneous (SC) injection.

Timeline

• Start date: 2020-01-21
• Primary completion: 2021-05-18
• Completion: 2025-06-23
• First posted: 2019-11-05
• Last updated: 2025-07-18
• Results posted: 2022-07-12

Locations

14 sites across 11 countries: United States, Australia, Belgium, France, Israel, Italy, Jordan, Lebanon, Netherlands, Turkey (Türkiye), United Arab Emirates

Regulatory

• FDA-regulated drug study