EUCTR2017-001619-35-BE
Active, Not Recruiting
Phase 1
Exploratory pathophysiological study in five patients suffering from new-onset lupus nephritis and treated with rituximab as first-line treatment - NL_RTX_FIRST
Cliniques Universitaires Saint-lus, Université catholique de Louvain0 sites5 target enrollmentApril 21, 2017
DrugsMabthera
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cliniques Universitaires Saint-lus, Université catholique de Louvain
- Enrollment
- 5
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \= 15y (except if local ethics committee imposes \= 18y) and \= 65 y
- •systemic lupus erythematosus, according to (ACR/SLICC criteria
- •early untreated Lupus nephritis class III or IV (ISN/RPS 2003\), associated or not to class V
- •uP/C ratio \=1 mg/mg measured in a 24\-h urine collection
- •No immunosuppressive therapy (never)
- •No targeted biological therapy never)
- •No renal failure (eGFR \< 60 mL/min)
- •No Biological and clinical nephrotic syndrome
- •Contraception (any type)
- •Signed informed consent (drafted according to local practice and approuved by the local ethics committee)
Exclusion Criteria
- •Breast\-feeding
- •Renal failure (eGFR \< 60 mL/min)
- •Biological and clinical nephrotic syndrome
- •HIV, HCV, HBV infections
- •Active tuberculosis
- •History of malignancy (except non\-melanoma skin and cervical intraepithelial cervical cancer)
- •Previous targeted biological therapy
- •Intercurrent disease interfering with treatment and/or clinical evaluation
Outcomes
Primary Outcomes
Not specified
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