KIDNEY DISEASES WITH PRIMARY GLOMERULAR AFFECTATION (glomerulonefritis membranosa, glomerulonefritis por cambios mínimos, vasculitis, glomerulosclerosis focal y segmentaria.)
Conditions
Interventions
Trade Name: Rixathon
Product Name: RITUXIMAB
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/mi
Sponsors
Vall d'Hebron Institute of Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients disgnosed with kidney disease with primary glomerular affectation (membranous glomerulonephritis, minimal-change glomerulonephritis, vasculitis, Focal segmental glomerulonephritis) - Patients whose best treatment option is rituximab, according to current international clinical guidelines. - Patients whose treatment has been approved by the Committee for Evaluation of Treatment Special Use in our Hospital. - Older than 18 years old - Who have not received rituximab in the last 6 months. - Who can commit for a year follow up in our hospital. 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 5
Exclusion criteria
Exclusion criteria: - Participation in any other clinical trial. - Limitations in understanding the Informed Consent. - Being unable to commit for 1 year follow up. - Live expectancy < 6 months. - Contraindication for rituximab treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objetive of this study is to characterize the rituximab pharmacokinetic profile in patients with kidney disease with primary glomerular involvement; as well as evaluating the influence of proteinuria, FCGRT polymorphism and the presence of anti-drug antibodies on rituximab clearance.;Secondary Objective: - To evaluate the impact of rituximab serum concentration on efficacy and safety one year after treatment (complete remission, partial remission, no remission, time to remission, relapse, tolerability, toxicity and adverse events) - In case parameters affecting rituximab pharmacokinetics are identified (such as proteinuria, FCGRT polymorphism and anti-drug antibodies), we aim to measure ther impact.;Primary end point(s): Primary endpoints are those related with rituximab pharmacokinetics: serum rituximab concentration (mcg/L), half live (h), distribution volume (ml/kg), serum clearance, Area under the curve (mch*h/L).;Timepoint(s) of evaluation of this end point: Day 1, 7, 15, 28 and 45. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy will be evaluated using proteinuria(grams of protein in urine collected during 24 hours and ratio between grams of protein:grams of creatinine in urine), albumin serum concentration, ANCA, AntiPLA2R, glomerular filtration, reactive C protein, limphocytes count.;Timepoint(s) of evaluation of this end point: Days 28, 45, 180 and 365. | — |
Countries
Spain
Contacts
Public ContactMaria Larrosa Garcia
Vall d'Hebron Institute of Research
Outcome results
None listed