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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000009
Receipt No. 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

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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 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
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
Scientific Title:Acronym 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
Region
Japan

Condition
Condition Steroid-resistant nephrotic syndrome in children
Classification by specialty
Nephrology Pediatrics
Classification by malignancy Others
Genomic information NO

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 1
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 60

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
Institute Japanese Study Group of Renal Disease in Children
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000014

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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