UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014967 |
|---|---|
| Receipt number | R000017347 |
| Scientific Title | A randomized, placebo-controlled double-blind, study evaluating the effect of pirfenidone in patients with chronic kidney disease and diabetes mellitus |
| Date of disclosure of the study information | 2014/08/27 |
| Last modified on | 2016/09/27 10:26:48 |
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Basic information
Public title
A randomized, placebo-controlled double-blind, study evaluating the effect of pirfenidone in patients with chronic kidney disease and diabetes mellitus
Acronym
Effect of pirfenidone on kidney function in patients with diabetic renal disease
Scientific Title
A randomized, placebo-controlled double-blind, study evaluating the effect of pirfenidone in patients with chronic kidney disease and diabetes mellitus
Scientific Title:Acronym
Effect of pirfenidone on kidney function in patients with diabetic renal disease
Region
| Japan |
Condition
Condition
Chronic kidney disease patients associated with diabetes mellitus
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to evaluate the efficacy of pirfenidone in patients with diabetic renal disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Change of inulin clearance, serum creatinine, eGFR, and albumin-to-creatinine ratio from baseline to end of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
placebo
Interventions/Control_2
pirfenidone
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Diabetic nephropathy patients whose diabetic stage is IIIa, IIIb or IV and CKD stage is G3a or G3b.
2)eGFR >=30 and <60 mL/min/1.73 m2
3)Treatment with ACEI and/or ARB for 3 months prior to the first dosing of investigational drug.
4)Written informed consent.
Key exclusion criteria
1)Items prohibited in pirfenidone package insert
2)History of allergy to lactose used as placebo
3)Investigator concludes that the patient's participation in this study is inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinari Tsuruta |
Organization
Meiyo Clinic,Hemodialysis Center
Division name
nephrology
Zip code
Address
6F,Meiyo-en Bldg. 64-3, Yatori-cho, Toyohashi-city, Aichi
TEL
0532-33-3130
y-tsuruta@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinari Tsuruta |
Organization
Meiyo Clinic, Hemodialysis Center
Division name
nephrology
Zip code
Address
6F,Meiyo-en Bldg. 64-3, Yatori-cho, Toyohashi-city, Aichi
TEL
0532-33-3130
Homepage URL
y-tsuruta@yahoo.co.jp
Sponsor or person
Institute
Meiyo Clinic, Hemodialysis Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
明陽クリニック（愛知県）Meiyo Clinic,Hemodialysis Center(Aichi)
成田記念病院（愛知県）Narita Memorial Hospital (Aichi)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 27 | Day |
Last modified on
| 2016 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017347
