UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001099 |
|---|---|
| Receipt number | 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 18:12:17 |
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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
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
izumi@hyo-med.ac.jp
Sponsor or person
Institute
Division of Kidney and Dialysis, Department of Internal Medicine,Hyogo College of Medicine
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001321
