UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Combination therapy of tacrolimus and intravenous cyclophosphamide for remission induction of lupus nephritis
Title of the study (Brief title)	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	Koichi Amano
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Rheumatology and Clinical Immunology
Address	1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL	049-228-3859
Email	amanokoi@saitama-med.ac.jp

Public contact
Name of contact person	Tsuneo Kondo
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Rheumatology and Clinical Immunology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005830