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Clinical Trials/EUCTR2011-005856-32-ES
EUCTR2011-005856-32-ESActive, not recruitingPhase 1

Comparison of the efficacy of two rituximab treatment regimens in patients with lupus nephropathyresistant to conventional treatment

Fundación Progreso y Salud0 sites9 target enrollmentStarted: January 27, 2012Last updated:
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
9

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • - Both men and women between 18 and 70 years.
  • -Patient with active lupus nephritis, previously treated with the following immunosuppressive unless contraindication: cyclophosphamide, azathioprine and mycophenolate (sodium or mophetil), who have not received rituximab in the two previous years, in whom regime was ineffective at least 3 months after treatment, or who experienced relapse during this time.
  • - Informed consent form signed.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

  • -Active/sepsis serious infections
  • -Known neoplasia
  • - Heart failure with III/IV functional class
  • -Pregnancy
  • -Known anaphylaxis to the product
  • -Cardiovascular disease or uncontrolled hypertension
  • -Chronic hepatitis B
  • -Serious Citopenia (granulocytes < 500/mm3, further < 10000/mm3)
  • -Immunodeficiency (CVI, IgA deficiency)
  • -Infection with HIV

Investigators

Sponsor
Fundación Progreso y Salud

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