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

Lupus Nephritis Clinical Trial

— RITULUP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01765842
• Other study ID #: RITULUP
• Status: Terminated
• Phase: Phase 3
• First received: January 3, 2013
• Last updated: July 9, 2015
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2013
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Biological:
• Rituximab
Only one cycle of rituximab will be administered in this arm.

Locations

Country	Name	City	State
Spain	San Cecilio Hospital	Granada
Spain	Carlos Haya Hospital	Málaga
Spain	Virgen del Rocío, Hospital	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud	Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete or partial response in lupus nephritis	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.	Assessment at 12 months	No
Secondary	Renal function	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	Yes
Secondary	Safety	Incidence of adverse events, serious adverse events and adverse events that led to the interruption of the study.	24 months of follow-up	Yes
Secondary	Rescue medication	Need for immunosuppressive treatment added to the experimental pattern: - Mycophenolate; - Azathioprine; - Methotrexate	24 months of follow-up	Yes
Secondary	Efficacy	Improvements in Selena-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) score results	24 months of follow-up	Yes