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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03804359
Other study ID # 17-APN-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 14, 2020
Est. completion date September 2023

Study information

Verified date February 2020
Source Centre Hospitalier Universitaire de Nice
Contact Barbara SEITZ-POLSKI, MD
Phone 04 92 03 55 02
Email seitz-polski.b@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized, open label, multicentre (20 sites), prospective trial comparing the efficacy of two therapeutic strategies to obtain clinical remission 1 year after diagnosis of Idiopathic Membranous Nephropathy with nephrotic syndrome and anti-PLA2R1 (phospholipase A2 receptor 1) antibodies:

- GEMRITUX protocol: 6 months of symptomatic antihypertensive and antiproteinuric therapy, and if the nephrotic syndrome persists at month-6 (urinary protein/creatinine ratio (UPCR) remains > 3.5 g/g and albuminemia < 30 g/l), two 375 mg/m2 rituximab infusions at 1-week interval.

- Personalized treatment:

- restricted anti-CysR activity at inclusion : 6-month symptomatic antihypertensive and antiproteinuric treatment (KDIGO)

- restricted anti-CysR activity after 6 months of symptomatic treatment with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 375 mg/m2 rituximab infusions at 1-week interval;

- Anti-CTLD (C-type lectin domains ) 1/7 activity at inclusion or after 6 months with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 1g rituximab infusions at 2-week interval at month 0 and/or month 6.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 years or more

- Anti-PLA2R1 activity detected by ELISA or Euroimmune Immunofluorescence Assay

- Nephrotic syndrome defined by proteinuria > 3.5 g/24h (or UPCR > 3.5 g/g) and serum albumin < 30 g/L at diagnosis

- eGFR (CKD-EPI) > 30 ml/min/1,73 m2 at diagnosis

- Symptomatic treatment according to KDIGO guidelines: maximal tolerated dose of NIAT : Non Immunosuppressive Antiproteinuric Treatment (angiotensin-converting enzyme inhibitor and/or angiotensin 2 receptor blockers, diuretics and statins)

- Medical insurance

- Signed informed consent

- Having understood and accepted the need for long-term medical follow-up

- Woman of child-bearing age must be using an effective method of contraception

Exclusion Criteria:

- Secondary Membranous Nephropathy: Membranous Nephropathy related to cancer, infectious, systemic lupus erythematosis, drug

- Anti-PLA2R1 antibodies not confirmed by central analysis (in this case the patient will be replaced)

- Pregnancy or breastfeeding

- Immunosuppressive treatment in the 3 last months

- Cancer under treatment

- Patient with complicated nephrotic syndrome that would require early immunosuppressive treatment (thrombosis, acute renal failureā€¦)

- Patients with active, severe infections or active hepatitis B

- Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients

- Patients in a severely immunocompromised state

- Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease

- Patients unable to give an informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rituximab
In the "personalized arm", the patient will be treated in function of the CysR activity result during the inclusion visit.

Locations

Country Name City State
France CHU D'amiens Hôpital Sud Amiens
France CHU Besançon Besançon
France Hôpital universitaire La Cavale Blanche Brest
France CHU de Caen Caen
France CHU Gabriel Montpied Clermont-Ferrand
France CHU Henri Mondor Créteil
France CHRU de LILLE Lille
France CHU de LYON NORD Lyon
France AP-HM Marseille
France CHRU de Montpellier Montpellier
France CHU de NANTES Nantes
France Dr Barbara SEITZ-POLSKI Nice
France CHU Carémeau Nîmes
France Hôpital Necker Paris
France Le Kremlin Bicêtre Paris
France Hôpital de la maison blanche Reims
France CHU de Strasbourg Strasbourg
France CHU de Toulouse Toulouse
France CHU de Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

References & Publications (5)

Glassock RJ. The pathogenesis of idiopathic membranous nephropathy: a 50-year odyssey. Am J Kidney Dis. 2010 Jul;56(1):157-67. doi: 10.1053/j.ajkd.2010.01.008. Epub 2010 Apr 8. Review. — View Citation

Lassalle M, Ayav C, Frimat L, Jacquelinet C, Couchoud C; Au Nom du Registre REIN. The essential of 2012 results from the French Renal Epidemiology and Information Network (REIN) ESRD registry. Nephrol Ther. 2015 Apr;11(2):78-87. doi: 10.1016/j.nephro.2014 — View Citation

Ponticelli C. Membranous nephropathy. J Nephrol. 2007 May-Jun;20(3):268-87. Review. — View Citation

Simon N, Couroucé AM, Lemarrec N, Trépo C, Ducamp S. A twelve year natural history of hepatitis C virus infection in hemodialyzed patients. Kidney Int. 1994 Aug;46(2):504-11. — View Citation

Simon P, Ramee MP, Boulahrouz R, Stanescu C, Charasse C, Ang KS, Leonetti F, Cam G, Laruelle E, Autuly V, Rioux N. Epidemiologic data of primary glomerular diseases in western France. Kidney Int. 2004 Sep;66(3):905-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical remission will be defined as a composite criterion combining (KDIGO definitions) Complete clinical remission: urinary protein/creatinine ratio (UPCR)<0.3 g/g in spot morning urine samples and serum albumin > 35 g/L and eGFR (epidermal growth factor receptor) > 60 ml/min/1.73 m2
Partial clinical remission: UPCR < 3.5 g/g with a decrease greater than 50% from baseline and serum albumin > 30 g/L and increase of serum creatinine lower than 20%
6 months
Secondary Immunological remission full PLA2R1 depletion measured by ELISA (titer<14RU (relative units) /ml) 6 months
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