UMIN-CTR Clinical Trial

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

idiopathic membranous nephropathy associated with nephrotic syndrome

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Division of Kidney and Dialysis, Department of Internal Medicine,Hyogo College of Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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