UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004893 |
|---|---|
| Receipt number | R000005830 |
| Scientific Title | Combination therapy of tacrolimus and intravenous cyclophosphamide for remission induction of lupus nephritis |
| Date of disclosure of the study information | 2011/01/18 |
| Last modified on | 2017/11/04 08:21:31 |
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Basic information
Public title
Combination therapy of tacrolimus and intravenous cyclophosphamide for remission induction of lupus nephritis
Acronym
Combination therapy of tacrolimus and intravenous cyclophosphamide for remission induction of lupus nephritis
Scientific Title
Combination therapy of tacrolimus and intravenous cyclophosphamide for remission induction of lupus nephritis
Scientific Title:Acronym
Combination therapy of tacrolimus and intravenous cyclophosphamide for remission induction of lupus nephritis
Region
| Japan |
Condition
Condition
lupus nephritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of combination therapy of tacrolimus and intravenous cyclophosphamide for remission induction of lupus nephritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete remission rate at 6 months after the start of protocol treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) Tacrolimus is usually administered orally at a dose of 3 mg/day immediately after informed consent is obtained.
It is allowed to decrease the dosage and/or intermit the administration within 2 weeks for reducing adverse effects.
2) Cyclophosphamide is usually administered intravenously at a dose of 500 mg/m2 per 2 weeks immediately after informed consent is obtained. Six-time administrations are usually performed.
It is allowed to decrease the total dosage of cyclophosphamide for reducing adverse effects.
3) The oral prednisolone is usually started at a dose of 0.6-1.0 mg/kg/day for 4 weeks immediately after informed consent is obtained, and then the dosage of prednisolone is usually reduced by 5 mg/day every 2-4 weeks to 20 mg/day; after that point, it is usually reduced by 2.5 mg/day every 2-4 weeks to a maintenance dosage of 5-10 mg/day.
4) Any other immunosuppressive drug (such as azathioprine, 6-mercaptoprine, cyclosporine and mizoribine) is not administered. High-dose steroid pulse therapy is not performed.
5) Any biologic DMARD is not administered.
Interventions/Control_2
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients are eligible if they meet all the following criteria.
1) Patients diagnosed as systemic lupus erythematosus according to the American College of Rheumatology criteria (1997).
2) Patients meeting either of the following criteria.
1. Either of the daily urinary protein (g) or the urinary protein creatinine ratio is 0.5 or more.
2. Erythrocytes or cellular casts in the urinary sediment are present.
3) Patients between 18 and 64 years of age, and providing written informed consent (if patients are less than 20 years old, their legal representatives also provide written informed consent ).
Key exclusion criteria
Patients are excluded if they meet any one of the following criteria.
1) Patients whose serum creatinine is 2 mg/dL or more; or creatinine clearance is 30 mL/min/1.73m2 or less.
2) Patients needing steroid pulse therapy.
3) Patients having received intravenous cyclophosphamide or steroid pulse therapy within 6 months of the start of the study.
4) Patients having suffered from hypersensitivity against the ingredients of tacrolimus capsules.
5) Patients administered with cyclosporine or bosentan.
6) Patients administered with potassium sparing diuretics.
7) Patients pregnant or suspected to be pregnant; or breast-feeding; or expecting to be pregnant during the study period.
8) Patients administered with pentostatin.
9) Patients having suffered from hypersensitivity against the ingredients of injectable cyclophosphamide.
10) Patients having a serious infectious disease.
11) Patients considered ineligible by a doctor in charge for other reason.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Amano |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Rheumatology and Clinical Immunology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
049-228-3859
amanokoi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuneo Kondo |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Rheumatology and Clinical Immunology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
049-228-3859
Homepage URL
t_kondo@saitama-med.ac.jp
Sponsor or person
Institute
Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 18 | Day |
Last modified on
| 2017 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005830
