UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized, placebo-controlled double-blind, study evaluating the effect of pirfenidone in patients with chronic kidney disease and diabetes mellitus
Title of the study (Brief title)	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	Yoshinari Tsuruta
Organization	Meiyo Clinic,Hemodialysis Center
Division name	nephrology
Address	6F,Meiyo-en Bldg. 64-3, Yatori-cho, Toyohashi-city, Aichi
TEL	0532-33-3130
Email	y-tsuruta@yahoo.co.jp

Public contact
Name of contact person	Yoshinari Tsuruta
Organization	Meiyo Clinic, Hemodialysis Center
Division name	nephrology
Address	6F,Meiyo-en Bldg. 64-3, Yatori-cho, Toyohashi-city, Aichi
TEL	0532-33-3130
Homepage URL
Email	y-tsuruta@yahoo.co.jp

Sponsor
Institute	Meiyo Clinic, Hemodialysis Center
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 03 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017347