UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025328
Receipt No. R000029135
Scientific Title A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis
Date of disclosure of the study information 2016/12/25
Last modified on 2018/06/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis
Acronym Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis
Scientific Title A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis
Scientific Title:Acronym Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis
Region
Japan Asia(except Japan)

Condition
Condition systemic lupus erythematosus
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Prospective, randomized, parallel-group controlled, open-label, international (Asian) multicenter, comparison of corticosteroids combined with TAC and corticosteroids combined with MMF.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of combined corticosteroids and TAC compared to combined corticosteroids and MMF in achieving sustained renal response (RR) in patients with active lupus nephritis [Class III/IV+/-V (LN)] [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Sustained RR defined as satisfying all of the following criteria:
1. proteinuria improved by >50% compared with baseline
2. 24-hr urine protein <1 g
3. serum creatinine not higher than 15% above baseline level
4. no occurrence of disease flare, defined as receiving 'rescue' increase of immunosuppressive therapy with any one of the following - requiring increase of prednisolone (or prednisone, or equivalent) dose to above 15 mg/D for 4 weeks or longer, change of originally assigned immunosuppressive agent, or addition of immunosuppressive medications prohibited in protocol
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tacrolimus
Interventions/Control_2 Mycophenolate Mofetil
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Biopsy-proven LN Class III/IV+/-V (ISN/RPS 2003), with biopsy performed within 12 weeks of randomization.
2. Positive anti-dsDNA.
3. Active LN with proteinuria (urine protein/creatinine ratio >1.0 or 24-hr urine protein >1.0 g at baseline), with or without hematuria.
4. Both 'incident' (i.e. new) patients and 'flare' patients can be included.
Key exclusion criteria 1. Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial disease, renovascular disease), or transplanted kidney.
2. Estimated glomerular filtration rate (eGFR by MDRD) =<20 mL/min per 1.73 m2 or serum creatinine >300 micromol/L (3.39 mg/dL) at screening.
3. Renal biopsy showing cellular or fibrocellular crescent in more than 25% of glomeruli.
4. CNS or other severe organ manifestation of lupus that necessitate aggressive immunosuppressive therapy on its own.
5. Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease).
6. Treatment with prednisolone (or prednisone, or equivalent) at >20 mg/D for over 4 weeks within the past 3 months.
7. Treatment with MMF at >1.5 g/D for over 4 weeks within the past 3 months.
8. Known hypersensitivity or intolerability to prednisolone (or prednisone, or equivalent), TAC, or MMF at a dose of 1.25 g or below per day.
9. Subjects who are already on treatment with TAC, cyclosporine or any other calcineurin inhibitor for over 4 weeks within the past 12 months.
10. Treatment with cyclophosphamide, leflunomide, or methotrexate for over 2 weeks, or use of biological agent(s) regardless of duration, within the past 6 months (Note: prior use of azathioprine, mizoribine, intravenous immunoglobulins and anti-malarials is allowed).
11. Uncontrolled hypertension with systolic BP >160 mmHg or diastolic BP >95 mmHg.
12. Women who are pregnant or breastfeeding.
13. Women with childbearing potential or their male partners, who refuse to use an effective birth control method
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tak-Mao Daniel Chan
Organization The University of Hong Kong
Division name Department of Medicine
Zip code
Address 4/F, Professional Block, Queen Mary Hospital
TEL +852-2255-4449
Email dtmchan@hku.hk

Public contact
Name of contact person
1st name
Middle name
Last name Tak-Mao Daniel Chan
Organization The University of Hong Kong
Division name Department of Medicine
Zip code
Address 4/F, Professional Block, Queen Mary Hospital
TEL +852-2255-4449
Homepage URL
Email dtmchan@hku.hk

Sponsor
Institute The University of Hong Kong
Institute
Department

Funding Source
Organization The University of Hong Kong
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02630628
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 19 Day
Last modified on
2018 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029135

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.