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Efficacy and safety of intravenous immunoglobulin with rituximab versus rituximab alone in childhood-onset steroid-dependent and frequently relapsing nephrotic syndrome: protocol for a multicentre randomised controlled trial
- Source :
- BMJ Open, Vol 10, Iss 9 (2020), BMJ Open, BMJ Open, BMJ Publishing Group, 2020, 10 (9), pp.e037306. ⟨10.1136/bmjopen-2020-037306⟩
- Publication Year :
- 2020
- Publisher :
- BMJ Publishing Group, 2020.
-
Abstract
- IntroductionGuidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking. Given the substantial impact of SDNS/FRNS on quality of life, strategies aiming to provide long-term remission while minimising treatment side effects are needed. Several studies confirm that rituximab is effective in preventing early relapses in SDNS/FRNS; however, the long-term relapse rate remains high (~70% at 2 years). This trial will assess the association of intravenous immunoglobulins (IVIgs) to rituximab in patients with SDNS/FRNS and inform clinicians on whether IVIg’s immunomodulatory properties can alter the course of the disease and reduce the use of immunosuppressive drugs and their side effects.Methods and analysisWe conduct an open-label multicentre, randomised, parallel group in a 1:1 ratio, controlled, superiority trial to assess the safety and efficacy of a single infusion of rituximab followed by IVIg compared with rituximab alone in childhood-onset FRNS/SDNS. The primary outcome is the occurrence of first relapse within 24 months. Patients are allocated to receive either rituximab alone (375 mg/m²) or rituximab followed by IVIg, which includes an initial Ig dose of 2 g/kg, followed by 1.5 g/kg injections once a month for the following 5 months (maximum dose: 100 g).Ethics and disseminationThe study has been approved by the ethics committee (Comité de Protection des Personnes) of Ouest I and authorised by the French drug regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé). Results of the primary study and the secondary aims will be disseminated through peer-reviewed publications.Trial registration numberNCT03560011.
- Subjects :
- Nephrology
Pediatrics
Nephrotic Syndrome
030204 cardiovascular system & hematology
[SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology
LEHA
law.invention
0302 clinical medicine
Superiority Trial
Randomized controlled trial
Quality of life
law
Recurrence
hemic and lymphatic diseases
Multicenter Studies as Topic
media_common
Randomized Controlled Trials as Topic
Renal Medicine
Immunoglobulins, Intravenous
Glomerulonephritis
General Medicine
3. Good health
Treatment Outcome
Medicine
Rituximab
Steroids
medicine.drug
Drug
medicine.medical_specialty
media_common.quotation_subject
nephrology
03 medical and health sciences
Internal medicine
medicine
Humans
030203 arthritis & rheumatology
[SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics
business.industry
paediatric nephrology
[SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy
medicine.disease
Quality of Life
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
Neoplasm Recurrence, Local
business
Nephrotic syndrome
glomerulonephritis
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Volume :
- 10
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....71f4d86b050a54cfb2d583dfbe47a494