Rituximab as first-line therapy in lupus nephritis

Phase 1

• Conditions: upus Nephritis; MedDRA version: 19.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-001619-35-BE
• Lead Sponsor: Cliniques Universitaires Saint-lus, Université catholique de Louvain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-21
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5

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)
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified