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