Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy (RITULUP)

Fundación Pública Andaluza Progreso y Salud

Status and phase: Terminated; Phase 3

Conditions: Lupus Nephritis

Treatments: Biological: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT01765842

RITULUP

Details and patient eligibility

About

Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments

Full 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).

Enrollment: 9 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Rituximab (1 cycle)

Active Comparator group

Description:

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

Treatment:

Biological: Rituximab

Rituximab (2 cycles)

Experimental group

Description:

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)

Treatment:

Biological: Rituximab