Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02770170
Registration number
NCT02770170
Ethics application status
Date submitted
11/05/2016
Date registered
12/05/2016
Date last updated
12/07/2021
Titles & IDs
Public title
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
Query!
Scientific title
A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year of Treatment, in Patients With Active Lupus Nephritis
Query!
Secondary ID [1]
0
0
2015-001750-15
Query!
Secondary ID [2]
0
0
1293.10
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Experimental: BI 655064 dose 1 -
Experimental: BI 655064 dose 2 -
Experimental: BI 655064 dose 3 -
Placebo comparator: Placebo -
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Patients With Complete Renal Response (CRR) at Week 52
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
At week 52.
Query!
Secondary outcome [1]
0
0
Percentage of Patients With Complete Renal Response (CRR) at Week 26
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
At week 26.
Query!
Secondary outcome [2]
0
0
Percentage of Patients With Partial Renal Response (PRR) at Week 26
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
At week 26.
Query!
Secondary outcome [3]
0
0
Percentage of Patients With Partial Renal Response (PRR) at Week 52
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
At week 52.
Query!
Secondary outcome [4]
0
0
Percentage of Patients With Major Renal Response (MRR) at Week 26
Query!
Assessment method [4]
0
0
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)
Query!
Timepoint [4]
0
0
At week 26.
Query!
Secondary outcome [5]
0
0
Percentage of Patients With Major Renal Response (MRR) at Week 52
Query!
Assessment method [5]
0
0
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)
Query!
Timepoint [5]
0
0
At week 52.
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
* Males and females 18-70 years. Women of childbearing potential must be ready and able (as assessed by investigator) 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.
* Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (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 (International Society of Nephrology (ISN)/Renal Pathology Society (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]
* Signed and dated written informed consent
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
* Clinically significant current other renal disease
* Glomerular Filtration Rate <30ml/min/1.73m²
* Dialysis within 12m of screening
* Antiphospholipid syndrome
* Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy
* Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigator's opinion would compromise the safety of the patient or the quality of the data
* Any induction therapy for Lupus Nephritis within the last 6 months prior to randomisation except induction with Mycophenolate Mofetil and high dose steroids started within 6 weeks prior to randomisation
* Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22,) within 12 months prior to randomisation
* Treatment with abatacept within 12 months prior to randomisation
* Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation
* Treatment with cyclophosphamid within 6 months prior to randomisation
* Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation
* Contraindication for MMF or corticosteroids and/or known hypersensitivity to any constituents of the study drug.
* Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical tuberculosis (TB) and/or a positive QuantiFERON TB-Gold test
* Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma.
* Live vaccination within 6 weeks before randomisation
* Patients unable to comply with the protocol in the investigator's opinion.
* Alcohol abuse in the opinion of the investigator or active drug abuse .
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Impaired hepatic function, defined as serum Aspartate Transferase/Alanine Transferase, bilirubin or alkaline phosphatase levels > 2 x Upper Limit of Normal
* Further exclusion criteria apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/05/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
18/08/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
121
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
The Prince of Wales Hospital - Randwick
Query!
Recruitment hospital [2]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
New York
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Tennessee
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Ontario
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Quebec
Query!
Country [8]
0
0
Czechia
Query!
State/province [8]
0
0
Hradec Kralove
Query!
Country [9]
0
0
Czechia
Query!
State/province [9]
0
0
Prague
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Creteil
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Paris
Query!
Country [12]
0
0
Germany
Query!
State/province [12]
0
0
Göttingen
Query!
Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Hamburg
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Köln
Query!
Country [15]
0
0
Germany
Query!
State/province [15]
0
0
Lübeck
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Mainz
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Stuttgart
Query!
Country [18]
0
0
Greece
Query!
State/province [18]
0
0
Athens
Query!
Country [19]
0
0
Greece
Query!
State/province [19]
0
0
Heraklion, Crete
Query!
Country [20]
0
0
Hong Kong
Query!
State/province [20]
0
0
HK
Query!
Country [21]
0
0
Hong Kong
Query!
State/province [21]
0
0
Hong Kong
Query!
Country [22]
0
0
Italy
Query!
State/province [22]
0
0
Padova
Query!
Country [23]
0
0
Japan
Query!
State/province [23]
0
0
Fukuoka, Kitakyushu
Query!
Country [24]
0
0
Japan
Query!
State/province [24]
0
0
Hokkaido, Sapporo
Query!
Country [25]
0
0
Japan
Query!
State/province [25]
0
0
Kanagawa, Kawasaki
Query!
Country [26]
0
0
Japan
Query!
State/province [26]
0
0
Miyagi, Sendai
Query!
Country [27]
0
0
Japan
Query!
State/province [27]
0
0
Okayama, Okayama
Query!
Country [28]
0
0
Japan
Query!
State/province [28]
0
0
Tokyo, Bunkyo-ku
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Tokyo, Shinjuku-ku
Query!
Country [30]
0
0
Korea, Republic of
Query!
State/province [30]
0
0
Suwon
Query!
Country [31]
0
0
Malaysia
Query!
State/province [31]
0
0
Ipoh
Query!
Country [32]
0
0
Malaysia
Query!
State/province [32]
0
0
Klang
Query!
Country [33]
0
0
Mexico
Query!
State/province [33]
0
0
Aguascalientes
Query!
Country [34]
0
0
Mexico
Query!
State/province [34]
0
0
Ciudad de Mexico
Query!
Country [35]
0
0
Mexico
Query!
State/province [35]
0
0
San Luis Potosi
Query!
Country [36]
0
0
Philippines
Query!
State/province [36]
0
0
Angeles City
Query!
Country [37]
0
0
Philippines
Query!
State/province [37]
0
0
Cebu City, Cebu
Query!
Country [38]
0
0
Philippines
Query!
State/province [38]
0
0
Cebu City
Query!
Country [39]
0
0
Philippines
Query!
State/province [39]
0
0
Davao
Query!
Country [40]
0
0
Philippines
Query!
State/province [40]
0
0
Lipa City, Batangas
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Bialystok
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Lodz
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Nowa Sol
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Radom
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Zamosc
Query!
Country [46]
0
0
Portugal
Query!
State/province [46]
0
0
Coimbra
Query!
Country [47]
0
0
Portugal
Query!
State/province [47]
0
0
Lisboa
Query!
Country [48]
0
0
Portugal
Query!
State/province [48]
0
0
Porto
Query!
Country [49]
0
0
Serbia
Query!
State/province [49]
0
0
Belgrade
Query!
Country [50]
0
0
Serbia
Query!
State/province [50]
0
0
Nis
Query!
Country [51]
0
0
Spain
Query!
State/province [51]
0
0
Barcelona
Query!
Country [52]
0
0
Spain
Query!
State/province [52]
0
0
Madrid
Query!
Country [53]
0
0
Spain
Query!
State/province [53]
0
0
Valencia
Query!
Country [54]
0
0
Thailand
Query!
State/province [54]
0
0
Bangkok
Query!
Country [55]
0
0
Thailand
Query!
State/province [55]
0
0
Chiangmai
Query!
Country [56]
0
0
Thailand
Query!
State/province [56]
0
0
Muang
Query!
Country [57]
0
0
United Kingdom
Query!
State/province [57]
0
0
Cambridge
Query!
Country [58]
0
0
United Kingdom
Query!
State/province [58]
0
0
Leicester
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02770170
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/70/NCT02770170/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/70/NCT02770170/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02770170
Download to PDF