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

July 9, 2015 updated by: Fundación Pública Andaluza Progreso y Salud

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

9

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18012
        • San Cecilio Hospital
      • Málaga, Spain, 29010
        • Carlos Haya Hospital
      • Seville, Spain, 41013
        • Virgen del Rocío, Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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:

  • 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

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:

  1. - Mycophenolate
  2. - Azathioprine
  3. - Methotrexate
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

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza Progreso y Salud

Collaborators

Ministry of Health, Spain

Investigators

  • Study Chair: María Jesús Castillo Palma, PhD, Virgen del Rocio Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2015

Last Update Submitted That Met QC Criteria

July 9, 2015

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.

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