Rituximab as first-line therapy in lupus nephritis

Exploratory pathophysiological study in five patients suffering from new-onset lupus nephritis and treated with rituximab as first-line treatment - NL_RTX_FIRST

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001619-35-BE

Enrollment

Registered

2017-04-21

Start date

2017-06-01

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis MedDRA version: 19.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: Mabthera Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 15y (except if local ethics committee imposes = 18y) and = 65 y systemic lupus erythematosus, according to (ACR/SLICC criteria early untreated Lupus nephritis class III or IV (ISN/RPS 2003), associated or not to class V uP/C ratio =1 mg/mg measured in a 24-h urine collection No immunosuppressive therapy (never) No targeted biological therapy never) No renal failure (eGFR =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy Breast-feeding Renal failure (eGFR < 60 mL/min) Biological and clinical nephrotic syndrome HIV, HCV, HBV infections Active tuberculosis History of malignancy (except non-melanoma skin and cervical intraepithelial cervical cancer) Previous targeted biological therapy Intercurrent disease interfering with treatment and/or clinical evaluation

Design outcomes

Primary

Measure	Time frame
Main Objective: OBJECTIVE: To study the effects of first-line Rituximab (RTX) therapy without interference with previous immunosuppressive treatments. This will require a ‘screening biopsy’ (standard of care) and a control biopsy performed 6 months after first RTX administration. The aim is not to demonstrate the clinical efficacy of this approach but to verify ex-vivo that RTX administered as a first-line therapy modulates favorably the renal lymphocyte B populations and could be effective in the absence of oral corticosteroid therapy. The renal and urinary lymphocyte B populations will be analysed in flow cytometry and also in single cell in order to study their transcriptome and to identify in the kidney and in the urines the presence of plasmablasts (present in large quantity in the untreated patients); and the presence of plasma cells and long-lived plasma cells (probably responsible for recurrences).;Secondary Objective: Not applicable;Primary end point(s): Disappearance of intra-renal and urinary plasmablasts (assessed by kidney biopsy and urine collection - Month 6 after initiation of RTX treatment);Timepoint(s) of evaluation of this end point: Month 6 after initiation of RTX treatment	—

Measure

Time frame

Main Objective: OBJECTIVE: To study the effects of first-line Rituximab (RTX) therapy without interference with previous immunosuppressive treatments. This will require a ‘screening biopsy’ (standard of care) and a control biopsy performed 6 months after first RTX administration. The aim is not to demonstrate the clinical efficacy of this approach but to verify ex-vivo that RTX administered as a first-line therapy modulates favorably the renal lymphocyte B populations and could be effective in the absence of oral corticosteroid therapy. The renal and urinary lymphocyte B populations will be analysed in flow cytometry and also in single cell in order to study their transcriptome and to identify in the kidney and in the urines the presence of plasmablasts (present in large quantity in the untreated patients); and the presence of plasma cells and long-lived plasma cells (probably responsible for recurrences).;Secondary Objective: Not applicable;Primary end point(s): Disappearance of intra-renal and urinary plasmablasts (assessed by kidney biopsy and urine collection - Month 6 after initiation of RTX treatment);Timepoint(s) of evaluation of this end point: Month 6 after initiation of RTX treatment

—

Secondary

Measure	Time frame
Secondary end point(s): 50% reduction in proteinuria Lowering of histological activity index (Morel-Maroger and NIH) assessed by second renal biopsy at Month 6 after initiation of RTX treatment. ;Timepoint(s) of evaluation of this end point: Month 6 after initiation of RTX treatment	—

Countries

Belgium

Contacts

Public Contactservice de rhumatologie

Université catholique de Louvain

tatiana.sokolova@uclouvain.be3202764 53 95

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026