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

NCT ID: NCT01765842

Last Updated: 2015-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-12-31

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).

Conditions

Lupus Nephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: BIOLOGICAL

Only one cycle of rituximab will be administered in this arm.

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)

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: BIOLOGICAL

Only one cycle of rituximab will be administered in this arm.

Interventions

Rituximab

Only one cycle of rituximab will be administered in this arm.

Intervention Type: BIOLOGICAL

Other Intervention Names

Mabthera

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Spain

OTHER_GOV

Sponsor Role: collaborator

Fundación Pública Andaluza Progreso y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

María Jesús Castillo Palma, PhD

Role: STUDY_CHAIR

Virgen del Rocío Hospital

Locations

San Cecilio Hospital

Granada, Granada, Spain

Carlos Haya Hospital

Málaga, Málaga, Spain

Virgen del Rocío, Hospital

Seville, Seville, Spain

Countries

Spain

Other Identifiers

RITULUP

Identifier Type: -

Identifier Source: org_study_id