UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001824 |
|---|---|
| Receipt number | 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 10:58:21 |
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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
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
Sponsor or person
Institute
Okayama University
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002201
