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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004893
Receipt No. 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

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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
Email 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
Email t_kondo@saitama-med.ac.jp

Sponsor
Institute Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005830

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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