Clinical trial NCT01765842: Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy
Official title: Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: Lupus Nephritis
remission
immunosuppressive treatment
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Spain
First posted: 2013-01-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of complete or partial response in lupus nephritis
timeFrame: Assessment at 12 months
Secondary outcomes:
measure: Renal function
timeFrame: 24 months of follow-up
measure: Safety
timeFrame: 24 months of follow-up
measure: Rescue medication
timeFrame: 24 months of follow-up
measure: Efficacy
timeFrame: 24 months of follow-up
Other outcomes:
Locations:
city: Granada
country: Spain
facility: San Cecilio Hospital
city: Málaga
country: Spain
facility: Carlos Haya Hospital
city: Seville
country: Spain
facility: Virgen del Rocío, Hospital
Study officials:
affiliation: Virgen del Rocío Hospital
name: María Jesús Castillo Palma, PhD
role: STUDY_CHAIR
References: