Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Enrolling By Invitation NCT07874074

Follow-up of Pediatric Patients Affected by Primary Hyperoxaluria Type 1 (PH1) Treated With Lumasiran

Conditions: Hyperoxaluria, Primary

Sex: All
Ages: 0 Years – 18 Years
Healthy volunteers: No
Enrollment: 30
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Location: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan Lombardy

Summary

The primary objective of the study is to confirm, in pediatric patients with type 1 hyperoxaluria treated with Lumasiran, the reduction in urinary oxalate excretion and plasma oxalate levels-already described at six months-on a larger number of patients and with an extended follow-up (1-5 years), and to evaluate in the same patients the ultrasound-detected reduction in the number of kidney stones over time from the initiation of treatment.

Eligibility Criteria

Inclusion Criteria: * Clinical diagnosis of type 1 hyperoxaluria with genetic confirmation prior to the initiation of treatment. * Initiation of Lumasiran treatment during the study period, OR * Initiation of Lumasiran treatment within the year immediately preceding the start of the study, provided that all data regarding the therapy already administered and the subsequent clinical course are available. Exclusion Criteria: * Patients with type 1 hyperoxaluria who have undergone prior liver or kidney transplantation * Patients with type 1 hyperoxaluria undergoing dialysis treatment

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07874074). StuddyBuddy aggregates publicly available trial information.