Idiopathic nephrotic syndrome Focal segmental glomerulosclerosis Minimal change disease
Conditions
Interventions
Product Name: Rituximab
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/m2 milligram(s)/square meter
Sponsors
Radboud University Nijmegen Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years Persistent proteinuria = 2 g/ 24 hours or a protein-to-creatinine ratio = 2 g/10mmol (2 g/g) after 8 weeks of treatment with high dose prednisone 1 mg/kg/day (max 80 mg/day) Idiopathic nephrotic syndrome caused by biopsy proven minimal change disease or focal segmental glomerulosclerosis 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Severe nephrotic syndrome with hypotension • Previous treatment with immunosuppressive medication other than prednisone • Treatment with prednisone > 10 weeks in last six months • Secondary form of FSGS or minimal change disease • Patients who test positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc). • Patients infected with HIV or suffering from other active infections • Patients inoculated with a live vaccine within 4 weeks prior to inclusion • Pregnancy, breast feeding, women with inadequate contraception • Malignancy • Kidney transplantation • Previous treatment with monoclonal antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evalute the efficacy of rituximab in comparison to continued corticosteroid treatment in ipatients with diopathic nephrotic syndrome unresponsive to 8 weeks of high dose prednisone.;Secondary Objective: 1. To evaluate the proportion of patients with partial and late remissions 2. To evaluate time to remission 3. To evaluate the proportion of patients with a relapse and difference in time to relapse 4. To evalauta the Quality of life measured by RAND-36 and TNO-AZL Questionnaire for Adult's Health-Related Quality of Life for people of 16 years and older (TAAQOL). 5. To evaluate the number and proportion of patients with side effects ? 6, To determine the cost-effectiveness and cost-utility 7. To evaluate differences in kidney function ? ;Primary end point(s): The proportion of patients reaching complete remission ;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients with a partial remission 2. Proportion of patients with a late remission (partial and complete) 3. Time to first remission (partial and complete) and time to relapse 4. Proportion of patients with a relapse 5. Need for immunosuppressive therapy other than assigned treatment with rituximab or prednisolone 6. Difference in quality of life measured by RAND-36 and TNO-AZL Questionnaire for Adult's Health-Related Quality of Life for people of 16 years and older (TAAQOL) 7. Proportion of patients with adverse events graded according to NCI-CTCAE v4.03 8. Cost-effectiveness analysis and cost -utility analysis 9. Difference in creatinine clearance and estimated glomerular filtration rate 10. Proportion of patients with an increase of serum creatinine > 50% ;Timepoint(s) of evaluation of this end point: ad1. 2 months ad2. 2-12 months ad 3. 12 months ad 4. 12 months ad 5. 2 and12 months ad 6. 2 and 12 months ad 7. 2 and 12 months ad 8. 2 and 12 months ad9. 2 and 12 months ad 10. 2 and 12 months | — |
Countries
Netherlands
Outcome results
None listed