Lupus Nephritis MedDRA version: 21.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: males and females 18-70 years. Women of childbearing potential* must be ready and able to use simultaneously two reliable methods of birth control,one of which must be highly effective. Highly effective method, per ICH M3 (R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly. The reliable contraception should be used before starting MMF therapy and the study drug, during the treatment and until 50 days after stopping MMF and the study drug. Sexually active men must be ready to use condoms during treatment with MMF and for at least 90 days after cessation of MMF treatment. Diagnosis of systemic lupus erythematosus (SLE) by ACR criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody or a positive antinuclear antibody (ANA) at screening or around time of start of induction therapy Lupus Nephritis Class III or IV (ISN/RPS 2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started Active renal disease evidenced by proteinuria >= 1.0 g/day (Uprot/Ucrea >= 1) at screening Signed and dated written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 109 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: clinically significant current other renal disease GFR 2 x ULN Significant central nervous system symptoms related to SLE based on investigator assessment Only for Germany: Hgb < 80 g/L, WBC count < 2.00 GI/L or platelet count = 50 GI/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: assess efficacy and safety of one year treatment with three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis;Secondary Objective: assess the efficacy at 6 months;Primary end point(s): 1: proportion of patients with complete renal response ;Timepoint(s) of evaluation of this end point: 1: week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: proportion of patients with complete renal response 2: proportion of patients with partial renal response 3: proportion of patients with major renal response ;Timepoint(s) of evaluation of this end point: 1: week 26 2: week 26 and 52 3: week 26 and 52 | — |
Countries
Australia, Austria, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Republic of, Malaysia, Philippines, Poland, Portugal, Serbia, Singapore, Spain, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed