Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
- Conditions
- Lupus Nephritis
- Interventions
- Drug: BI 655064 dose 1Drug: BI 655064 dose 2Drug: BI 655064 dose 3Drug: Placebo
- Registration Number
- NCT02770170
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 655064 dose 1 BI 655064 dose 1 - BI 655064 dose 2 BI 655064 dose 2 - BI 655064 dose 3 BI 655064 dose 3 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percentage of Patients With Complete Renal Response (CRR) at Week 52 At week 52. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day at Week 52 and either estimated glomerular filtration rate (eGFR) within normal range at Week 52 or decrease in eGFR \< 20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min).
CRR at Week 52 (derived using UP from the 24 h urine collections) was analyzed using a logistic regression model. Factors in the model included treatment and the covariates race (Asian/Non-Asian) and proteinuria at screening (UP/urine creatinine (UC) \<3 or \>=3 g/day).
Pairwise comparisons of the modelled proportions of patients with CRR at each dose level to placebo were performed.
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Partial Renal Response (PRR) at Week 52 At week 52. Partial renal response (PRR) was defined as at least 50% reduction of proteinuria from baseline if estimated glomerular filtration rate (eGFR) was within normal range at time of assessment or decrease of eGFR \<20% from baseline if eGFR was below normal range at time of assessment.
Percentage of Patients With Complete Renal Response (CRR) at Week 26 At week 26. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day at Week 26 and either estimated glomerular filtration rate (eGFR) within normal range at Week 26 or decrease in eGFR \< 20% from baseline at Week 26 if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min).
Percentage of Patients With Partial Renal Response (PRR) at Week 26 At week 26. Partial renal response (PRR) was defined as at least 50% reduction of proteinuria from baseline if estimated glomerular filtration rate (eGFR) was within normal range at time of assessment or decrease of eGFR \<20% from baseline if eGFR was below normal range at time of assessment.
Percentage of Patients With Major Renal Response (MRR) at Week 26 At week 26. Major renal response was defined as follows depending on proteinuria at baseline:
* If baseline proteinuria was \<3 g/day and patient had complete renal response (CRR)
* If baseline proteinuria was \>= 3 g/day and proteinuria \< 1 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \<20% from baseline at Week 26 if eGFR was below normal range (below lower limit of normal (LLN), where LLN = 90 mL/min)Percentage of Patients With Major Renal Response (MRR) at Week 52 At week 52. Major renal response was defined as follows depending on proteinuria at baseline:
* If baseline proteinuria was \<3 g/day and patient had complete renal response (CRR)
* If baseline proteinuria was \>= 3 g/day and proteinuria \< 1 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \<20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal (LLN), where LLN = 90 mL/min)
Trial Locations
- Locations (74)
Feinstein Institute for Medical Research
🇺🇸Manhasset, New York, United States
Hospital Curry Cabral, EPE
🇵🇹Lisboa, Portugal
Institute of Rheumatology, Belgrade
🇷🇸Belgrade, Serbia
Pramongkutklao Hospital
🇹🇭Bangkok, Thailand
University General Hospital Attikon
🇬🇷Athens, Greece
Leicester General Hospital
🇬🇧Leicester, United Kingdom
Integrity Clinical Research, LLC
🇺🇸Doral, Florida, United States
Office of Dr. Ramesh C. Gupta
🇺🇸Memphis, Tennessee, United States
Columbia University Medical Center-New York Presbyterian Hospital
🇺🇸New York, New York, United States
Integral Rheumatology and Immunology Specialist
🇺🇸Plantation, Florida, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Hope Clinical Research
🇺🇸Kissimmee, Florida, United States
CHU de Quebec-Universite Laval Research Centre
🇨🇦Quebec, Canada
The Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
🇩🇪Lübeck, Germany
Academic Medical Research Institute
🇺🇸Los Angeles, California, United States
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
Universitätsklinikum Köln (AöR)
🇩🇪Köln, Germany
HOP Henri Mondor
🇫🇷Creteil, France
Robert-Bosch-Krankenhaus GmbH
🇩🇪Stuttgart, Germany
Hospital of the University of Occupational and Environmental Health
🇯🇵Fukuoka, Kitakyushu, Japan
St. Marianna University School of Medicine Hospital
🇯🇵Kanagawa, Kawasaki, Japan
Instituto Nacional de Cs Médicas y Nutrición S Zubiran
🇲🇽Ciudad de Mexico, Mexico
Military Medical Academy
🇷🇸Belgrade, Serbia
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Emory University
🇺🇸Atlanta, Georgia, United States
Northwell Health
🇺🇸Great Neck, New York, United States
General University Hospital Prague 2, Nephrology Clinic
🇨🇿Prague, Czechia
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Institute of Rheumathology Prague
🇨🇿Prague, Czechia
HOP La Pitié Salpêtrière
🇫🇷Paris, France
Universitätsmedizin Göttingen, Georg-August-Universität
🇩🇪Göttingen, Germany
General Hospital of Athens "Laiko"
🇬🇷Athens, Greece
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
University General Hospital of Heraklion
🇬🇷Heraklion, Crete, Greece
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Azienda Ospedaliera Universitaria di Padova
🇮🇹Padova, Italy
Tohoku University Hospital
🇯🇵Miyagi, Sendai, Japan
Okayama University Hospital
🇯🇵Okayama, Okayama, Japan
Juntendo University Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Sapporo, Japan
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Keio University Hospital
🇯🇵Tokyo, Shinjuku-ku, Japan
Instituto Nacional de Cardiologia Ignacio Chavez
🇲🇽Ciudad de Mexico, Mexico
H. Central Dr Ignacio M. P.
🇲🇽San Luis Potosi, Mexico
Angeles University Foundation Medical Center
🇵🇭Angeles City, Philippines
Cebu Doctors Hospital
🇵🇭Cebu City, Cebu, Philippines
Southern Philippines Medical Center
🇵🇭Davao, Philippines
Norbert Barlicki University Clinical Hospital No.1, Lodz
🇵🇱Lodz, Poland
Clinic Medical Center; Nowa Sol
🇵🇱Nowa Sol, Poland
NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom
🇵🇱Radom, Poland
John Paul II Regional Hospital, Zamosc
🇵🇱Zamosc, Poland
CHULN, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Centro Hospitalar Universitário São João,EPE
🇵🇹Porto, Portugal
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Clinical Centre Nis
🇷🇸Nis, Serbia
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Dr. Peset
🇪🇸Valencia, Spain
Chiangmai University
🇹🇭Chiangmai, Thailand
Naresuan University Hospital
🇹🇭Muang, Thailand
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Hospital Raja Permaisuri Bainun
🇲🇾Ipoh, Malaysia
Hospital Cardiologica Aguascalientes
🇲🇽Aguascalientes, Mexico
Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard
🇵🇱Lodz, Poland
Chong Hua Hospital
🇵🇭Cebu City, Philippines
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
🇵🇹Coimbra, Portugal
University Clinical Hospital in Bialystok I
🇵🇱Bialystok, Poland
King Chulalongkorn Memorial Hospital
🇹🇭Bangkok, Thailand
Siriraj Hospital
🇹🇭Bangkok, Thailand
Hospital Tengku Ampuan Rahimah
🇲🇾Klang, Malaysia
Mary Mediatrix Medical Center
🇵🇭Lipa City, Batangas, Philippines
Guy's Hospital
🇬🇧London, United Kingdom
Prince of Wales Hospital
🇭🇰HK, Hong Kong