Follow-up of patients with primary hyperoxaluria type 1 treated with Lumasiran in France
Official title: Retrospective and Prospective Follow-up of Patients With Primary Hyperoxaluria Type 1 Treated With Lumasiran in France - DAILY-LUMA
Run by Hospices Civils de Lyon · NCT06225882 · Data updated 2026-11-12
This study is looking at how well Lumasiran works and how safe it is for people in France with primary hyperoxaluria type 1 over five years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 99 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 7 sites (Besançon and 6 other locations) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | January 1, 2024 |
| Study ends | December 31, 2026 |
| Registry record updated | January 26, 2024 |
| Trial ID | NCT06225882 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with primary hyperoxaluria type 1 who have received treatment with Lumasiran.
✕Probably not a fit
Patients who have not been treated with Lumasiran or those who oppose participation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study involves both retrospective and prospective follow-up of patients diagnosed with primary hyperoxaluria type 1 (PH1) who have been treated with Lumasiran in France. The aim is to monitor the long-term efficacy and safety of Lumasiran by evaluating the evolution of oxaluria and other clinical parameters over a period of five years. The study will include standardized clinical, biological, and radiological assessments to gather comprehensive data on patient management and outcomes. This approach seeks to fill the gap in knowledge regarding the long-term effects of Lumasiran treatment.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term management and outcomes of patients with primary hyperoxaluria type 1 treated with Lumasiran.
How similar studies have gone: While there have been clinical trials on Lumasiran, this study aims to provide novel long-term data on its effects in a real-world setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with primary hyperoxaluria type 1 who has been treated with Lumasiran, since the beginning of the ATU (temporary authorization for use) and in post-marketing. Exclusion Criteria: * Opposition of the patient or his legal representatives for minors. * Not covered by social security.
Where it's running
-
CHU de Besançon
Besançon, France Recruiting -
Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant
Bron, France Recruiting -
Hopital Edouard Herriot
Lyon, France Recruiting -
AP-HM - Timone Enfants
Marseille, France Recruiting -
Hôpital Européen G. Pompidou
Paris, France Recruiting -
CHU Paris - Hôpital Necker-Enfants Malades
Paris, France Recruiting
Show 1 more location
-
Hôpital Necker, APHP Paris, Service de néphrologie-dialyse, 149 rue de Sèvres
Paris, Île-de-France Region, France Recruiting
Study contacts
- Study coordinator: Mélissa CLOAREC, Clinical Research Associate
- Email: melissa.cloarec@chu-lyon.fr
- Phone: 04 27 85 51 54
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.