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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001824
Receipt No. R000002201
Scientific Title Therapeutic effect of an immunosupp-ressive agent, mizoribine in patients with the progression of renal failure in diabetic nephropathy
Date of disclosure of the study information 2009/03/31
Last modified on 2009/03/31

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Basic information
Public title Therapeutic effect of an immunosupp-ressive agent, mizoribine in patients with the progression of renal failure in diabetic nephropathy
Acronym Therapeutic effect of mizoribine in patients with diabetic nephropathy
Scientific Title Therapeutic effect of an immunosupp-ressive agent, mizoribine in patients with the progression of renal failure in diabetic nephropathy
Scientific Title:Acronym Therapeutic effect of mizoribine in patients with diabetic nephropathy
Region
Japan

Condition
Condition Diabetic nephropathy
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of MZR in pre-venting the progression of diabetic nephropathy, we compare two groups of patients, receiving either conven-tional treatment alone or such treat-ment paired with MZR in crossover study. Primary endpoint is the gradient of the reciprocal serum creatinine level between MZR treated and non-treated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The mean gradient of the reciprocal serum creatinine levels between MZR treated and non-treated.
Key secondary outcomes The frequency of lethal event and non-lethal event.Lethal event: myocardial infarction(angina pectoris)Non-lethal event: state of renal failure increasing to 5.00mg/dl or more of s-Cr. level.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Conventional therapy for diabetic nephropathy
Interventions/Control_2 Conventional therapy for diabetic nephropathy + MZR
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
20 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria Diabetic nephropathy patients with retinopathy.Patients who had diabetes mellitus for at least 5 years.Urinary protein excretion of over 1.0g/dayThe mean gradient of 3 or more of the reciprocal serum creatinine levels before 6 months is below -0.005
Key exclusion criteria Patients who is received cortico- steroid or immunosuppressant.Patients whose blood pressure is over 160/100mmHg or whose HbA1c is over 10.0%.Patients with a hypersensitivity to MZR.Patients whose WBC are under 3000/mm3.Pregnant or nursing women.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Makino
Organization Okayama University
Division name Nephrology Diabetology and Endocrinology
Zip code
Address 2-5-1 Shikata-cho Okayama-shi Okayama-ken 700-8558
TEL 086-223-7151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ken-ichi Shikata
Organization Okayama University
Division name Nephrology Diabetology and Endocrinology
Zip code
Address 2-5-1 Sikata-cho Okayama-shi okayama-ken 700-8558
TEL 086-223-7151
Homepage URL
Email

Sponsor
Institute Okayama University
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
2009 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
2008 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2012 Year 04 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
2009 Year 03 Month 31 Day
Last modified on
2009 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002201

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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