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
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