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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001099
Receipt No. R000001321
Scientific Title Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome
Date of disclosure of the study information 2008/03/31
Last modified on 2008/03/19

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Basic information
Public title Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome
Acronym Optimal use of ciclosporin in membranous nephropathy (OCIM-NS study)
Scientific Title Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome
Scientific Title:Acronym Optimal use of ciclosporin in membranous nephropathy (OCIM-NS study)
Region
Japan

Condition
Condition idiopathic membranous nephropathy associated with nephrotic syndrome
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Decision of optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes quantity of urinary protein, frequency of relapse, renal function (serum Cr, estimated GFR),time to remission, total dose of steroid (until remission)
Key secondary outcomes adverse effects of steroid and ciclosporin, total dose of steroid (in all treatment period), duration of hospitalization, serum albumin, serum total protein, serum total cholesterol, degree of edema

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Steroid group: Immunosuppressive therapy is started by predonisolone 0.8mg/kg/day (max 60mg/day). The dose is decreased by 5mg/day in 2 to 4 weeks after remission. The cases who do not reach remission for 4 weeks, predonisolone is decreased to 0.6mg/kg/day, and ciclosporin (2mg/kg/day) is started once a day. Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.)
Interventions/Control_2 Steroid + ciclosporin group: Immunosupressive therapy is started by predonisolone 0.6mg/kg/day and ciclosporin 2mg/kg/day (once a day). Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.) The dose of predonisolone is decreased by 5mg/day in 2 to 4 weeks after remission. Ciclosporin is continued after remission. (The target C2 is 600-800 ng/mL.) The cases who do not reach remission after 4 weeks, predonisolone is decreased by 5mg/4-8week, and ciclosporin is continued for 6 months. The target C2 is 800-1000ng/mL. At 6 months after, the therapy of non-respnder is not restricted.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The cases of idiopathic membranous nephropathy associated with nephrotic syndrome are included in this study. (Diagnosis is done under the criteria of research group of Ministry of Health, Labour and Welfare.) Written informed concent is needed.
Key exclusion criteria The cases who are considered inappropriate under "Guideline of ciclosporin therapy in nephrotic syndrome" or each doctor's decisions.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Nakanishi
Organization Hyogo College of Medicine
Division name Division of Kidney and Dialysis, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa, NIshinomiya, Hyogo, Japan
TEL 0798-45-6521
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Izumi
Organization Hyogo College of Medicine
Division name Division of Kidney and Dialysis, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa, NIshinomiya, Hyogo, Japan
TEL 0798-45-6521
Homepage URL
Email izumi@hyo-med.ac.jp

Sponsor
Institute Division of Kidney and Dialysis, Department of Internal Medicine,Hyogo College of Medicine
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
2008 Year 03 Month 31 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
Date of protocol fixation
2007 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2010 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 03 Month 27 Day
Last modified on
2008 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001321

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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