Lupus Nephritis
Conditions
Keywords
Lupus Nephritis, remission, immunosuppressive treatment
Brief summary
Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments
Detailed description
Randomized, open, controlled, multicenter, clinical trial in patients with lupus nephritis previously treated with cyclophosphamide and mycophenolate. These patient can not have received Rituximab in the previous year. The number of patients estimated to reach statistical significance is 18 in each arm, a total sample size of 32 patients is needed. The hypothesis is that the alternative procedure (a second cycle of Rituximab)will reduce the relapse rate of lupus nephritis and the consequent deterioration of renal function. Besides it will reduce health care expenses(hospitalization, medication, hemodialysis and renal transplantation).
Interventions
BIOLOGICALRituximab
Only one cycle of rituximab will be administered in this arm.
Sponsors
Ministry of Health, Spain
Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Both men and women between 18 and 70 years. * Patient with active lupus nephritis, previously treated with cyclophosphamide and mycophenolate (sodium or mofetil), who have not received rituximab in the previous year. * Women in childbearing age must have a pregnancy test in serum or urine negative and should use a contraceptive method suitable since at least 14 days prior to their inclusion in the study and up to 6 months after the last dose of the medication of the test. * Informed consent form signed.
Exclusion criteria
* Patients treated with rituximab in the previous years * Active/sepsis serious infections * Renal biopsy showing interstitial fibrosis and/or glomerular over 75%. * Known neoplasia * Heart failure with III/IV functional class * Pregnancy * Nursing * Known anaphylaxis to the product * History of hepatitis c * History of tuberculosis * Cardiovascular disease or uncontrolled hypertension * Chronic hepatitis B * Serious Cytopenia (granulocytes \< 500/mm3, further \< 10000/mm3) * Immunodeficiency (CVI, immunoglobulins deficiency) * Infection with HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete or partial response in lupus nephritis | Assessment at 12 months | Complete response defined as: * Glomerular Filtration Rate (GFR)≥ 60, 73 m2 (or decline to baseline or ± 15% of baseline in those with GFR \<60 ml/min/1, 73m2). * Proteinuria ≤ 0.5 g/24 hours. * Inactive urine sediment (red cells, white cells, red cell casts according to local laboratory ranges). * Serum albumin\> 3 g / dl Partial response defined as: In patients with proteinuria ≥ 3.5 gr/24 h , decreased proteinuria \<3.5 gr/24 hours. * In patients with baseline proteinuria \<3.5 gr/24 hours, reduced proteinuria\> 50% of baseline. * In both situations, stabilization (± 25%) or reduce of the Glomerular Filtration Rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 24 months of follow-up | Improvements in Selena-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) score results |
| Renal function | 24 months of follow-up | Proportion of patients achieving a stabilization of renal function (Glomerular filtration rate of ± 25% over baseline or serum creatinine within normal range) |
| Safety | 24 months of follow-up | Incidence of adverse events, serious adverse events and adverse events that led to the interruption of the study. |
| Rescue medication | 24 months of follow-up | Need for immunosuppressive treatment added to the experimental pattern: 1. \- Mycophenolate 2. \- Azathioprine 3. \- Methotrexate |
Countries
Spain
Outcome results
None listed