UMIN-CTR Clinical Trial

Unique ID issued by UMIN	C000000009
Receipt number	R000000014
Scientific Title	Treatment for steroid-resistant nephrotic syndrome in children: a combination of cyclosporine and prednisolone in minimal change and a combination of methylprednisolone, cyclosporine and prednisolone in FSGS
Date of disclosure of the study information	2005/08/01
Last modified on	2009/08/11 11:56:56

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Basic information

Public title

Treatment for steroid-resistant nephrotic syndrome in children: a combination of cyclosporine and prednisolone in minimal change and a combination of methylprednisolone, cyclosporine and prednisolone in FSGS

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Steroid-resistant nephrotic syndrome in children

Classification by specialty

Nephrology Pediatrics

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

We investigate efficacy and safety of a combination of cyclosporine and prednisolone and a combination of methylprednisolone, cyclosporine and prednisolone for steroid-resistant nephrotic syndrome in children.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Complete remission rate

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

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Cyclosporine+prednisolone
Methylprednisolone+cyclosporine+prednisolone

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

1 years-old <=

Age-upper limit

18 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Primary nephrotic syndrome (proteinuria with a urinary protein-creatinine ratio >1.8 and hypoalbuminemia with serum albumin level <2.5 g/dL).
2.Corticosteroid resistance after 4 weeks of daily prednisolone, or serum albumin level <2.5 g/dL after 4 subsequent weeks of alternate-day therapy, in cases of partial remission despite 4 weeks of daily prednisolone, based on the International study of kidney disease in children.
3.Biopsy diagnoses of MCNS, MPGN or FSGS, where a renal biopsy has been performed within 8 weeks before eligibility.
4.Aged twelve months to 18 years.
5.Written informed consent from the patients' parents or legal guardians.

Key exclusion criteria

1.Congenital nephrotic syndrome.
2.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus).
3.Medical history of allergy or hypersensitivity reactions to methylprednisolone and cyclosporine.
4.Poorly controlled hypertension.
5.Chronic renal dysfunction.
6.Active infectious disease.
7.Severe liver disfunction.
8.History of cyclosporine administration.
9.Pregnancy.
10.Judged inappropriate for this study by the physicians.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Masataka Honda

Organization

Tokyo Metropolitan Children's Hospital

Division name

Department of Pediatrics

Zip code

Address

4-33-13 Daimachi Hachioji City,Tokyo

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name

Organization

Japanese Study Group of Renal Disease in Children

Division name

Department of Nephrology, Tokyo Metropolitan Children's Hospital

Zip code

Address

TEL

Homepage URL

Email

Sponsor or person

Institute

Japanese Study Group of Renal Disease in Children

Institute

Department

Personal name

Funding Source

Organization

The Kidney Foundation,Japan

Organization

Division

Category of Funding Organization

Non profit foundation

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 01 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

2001 Year 04 Month 01 Day

Date of IRB

Anticipated trial start date

2001 Year 04 Month 01 Day

Last follow-up date

2007 Year 05 Month 01 Day

Date of closure to data entry

2009 Year 04 Month 01 Day

Date trial data considered complete

2009 Year 04 Month 01 Day

Date analysis concluded

2009 Year 04 Month 01 Day

Other

Other related information

Management information

Registered date

2005 Year 06 Month 14 Day

Last modified on

2009 Year 08 Month 11 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000014