Long-term relapse after treatment of lupus nephritis (LN) resistant to conventional treatment MedDRA version: 14.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: MabThera
Product Name: Rituximab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/m2 milligram(s)/sq
Sponsors
Fundación Progreso y Salud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Both men and women between 18 and 70 years. -Patient with active lupus nephritis, previously treated with the following immunosuppressive unless contraindication: cyclophosphamide, azathioprine and mycophenolate (sodium or mophetil), who have not received rituximab in the two previous years, in whom regime was ineffective at least 3 months after treatment, or who experienced relapse during this time. - Informed consent form signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: -Active/sepsis serious infections -Known neoplasia - Heart failure with III/IV functional class -Pregnancy -Nursing -Known anaphylaxis to the product -Cardiovascular disease or uncontrolled hypertension -Chronic hepatitis B -Serious Citopenia (granulocytes < 500/mm3, further < 10000/mm3) -Immunodeficiency (CVI, IgA deficiency) -Infection with HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Rate of complete or partial response to the 12, 18 and 24 months, defined as: -Complete response: proteinuria < 0.75 mg per minute (or equivalent in 24h urine, proteinura or urine protein/creatinine index) while maintaining estimated glomerular filtration rate or serum creatinine within the normal range. - Partial response: improvement ? 50% and stabilization of kidney function (glomerular filtration of ± 25% compared to the basal value or serum creatinine within the normal range ).;Secondary Objective: Proteinuria < 0.75 mg per minute at 12, 18 and 24 months of follow-up. Estimated glomerular filtration or serum creatinine within the normal range at 12, 18 and 24 months of follow-up. Improvement ? 50% of proteinuria, hematuria, or leucoituria 12, 18 and 24 months. Proportion of patients who reach a stabilization of kidney function (glomerular filtration of ±25% compared to the basal value or serum creatinine within the normal range) 12, 18 and 24 months of follow-up. Active urinary sediment in a basal position with an inactive urine sediment at 12, 18 and 24 months of follow-up.;Primary end point(s): Rate of complete or partial response defined as: -Complete response: proteinuria < 0.75 mg per minute (or equivalent in 24h urine, proteinura or urine protein/creatinine index) while maintaining estimated glomerular filtration rate or serum creatinine within the normal range. - Partial response: improvement ? 50% and stabilization of kidney function (glomerular filtration of ± 25% compared to the basal value or serum creatinine within the normal range ).;Timepoint(s) of evaluation of this end point: 12, 18 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proteinuria 20 U/mcl or leukocytes > 30 U/mcl - Inactive urine sediment is defined by hematies < 20 U/mcl and leukocytes < 30 U/mcl - Duration of the renal response - Number of cycles of RTX administered in the period of study. - Incidence of adverse events (AA), serious adverse events (AAG), and AA that led to the interruption of the study.;Timepoint(s) of evaluation of this end point: 12, 18 and 24 months | — |
Countries
Spain
Contacts
Public ContactClara Maria Rosso
Unidad de Investigación Clínica y Ensayos Clínicos. Hospital Universitario Virgen del Rocio.
Outcome results
None listed