Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy (RITULUP)
Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments.
Study Overview
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).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Granada, Spain, 18012
- San Cecilio Hospital
-
Málaga, Spain, 29010
- Carlos Haya Hospital
-
Seville, Spain, 41013
- Virgen del Rocío, Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Rituximab (1 cycle)
1 cycle of Rituximab (4 i.v. infusions): Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2 |
Only one cycle of rituximab will be administered in this arm.
Other Names:
|
|
Experimental: Rituximab (2 cycles)
A second cycle of Rituximab First cycle of Rituximab (4 i.v. infusions): Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2 Second cycle of Rituximab (4 i.v. infusions, 6 months later) |
Only one cycle of rituximab will be administered in this arm.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of complete or partial response in lupus nephritis
Time Frame: Assessment at 12 months
|
Complete response defined as:
Partial response defined as: In patients with proteinuria ≥ 3.5 gr/24 h , decreased proteinuria <3.5 gr/24 hours.
|
Assessment at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Renal function
Time Frame: 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)
|
24 months of follow-up
|
|
Safety
Time Frame: 24 months of follow-up
|
Incidence of adverse events, serious adverse events and adverse events that led to the interruption of the study.
|
24 months of follow-up
|
|
Rescue medication
Time Frame: 24 months of follow-up
|
Need for immunosuppressive treatment added to the experimental pattern:
|
24 months of follow-up
|
|
Efficacy
Time Frame: 24 months of follow-up
|
Improvements in Selena-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) score results
|
24 months of follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: María Jesús Castillo Palma, PhD, Virgen del Rocio Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- RITULUP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.