UMIN-CTR Clinical Trial

Basic information
Public title	Effect of telmisartan on patients with renal dysfunction
Acronym	Effect of telmisartan on patients with renal dysfunction
Scientific Title	Effect of telmisartan on patients with renal dysfunction
Scientific Title:Acronym	JINNAGA
Region	Japan

Condition
Condition	Chronic Kidney Disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the dose-dependent renoprotective effect and safety of long-term administration of the angiotensin II receptor blocker telmisartan on patients with CKD stage 3, 4 without nephrotic level proteinuria.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	A composite of doubling serum creatinine, transition to chronic kidney disease stage 5, the onset of end-stage renal disease, or death from any causes within 104 weeks.
Key secondary outcomes	Amount of urinary protein, and decreased eGFR during the 104 weeks.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
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	telmisartan 20 mg for 4 weeks and up-titrating telmisartan to 40 mg at 4 weeks and continuing the same dose until 104 weeks
Interventions/Control_2	telmisartan 20 mg for 4 weeks and up-titrating telmisartan to 40 mg at 4 weeks and increasing up to 80 mg and continuing the same dose until 104 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients are included if they are at least 20 years of age, chronic kidney disease stage 3-4 with estimated glomerular filtration rate of 15-60 ml/min/1.73 m2, receiving anti hypertensive therapy, and have sustained blood pressure control
Key exclusion criteria	heavy liver dysfunction and/or poor bile secretion, possibility of pregnancy or lactation, past history of hypersensitivity for telmisartan or its analogous drugs, nephrotic proteinuria, corticosteroids or immunosuppressant agents within the past 6 months, acute myocardial infarction within 6 months, congestive heart failure, cerebral infarction, transient ischemic attack, and renal artery stenosis
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shigeru Middle name Last name Kohno
Organization	Nagasaki University Hospital
Division name	Second Internal Medicine
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL	095-819-7273
Email	s-kohno@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Tomoya Middle name Last name Nishino
Organization	Nagasaki University Hospital
Division name	Nephrology
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL	0958197282
Homepage URL
Email	tnishino@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Nagasaki University Hospital
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	IRB of Nagasaki University Hospital
Address	1-7-1 Sakamoto, Nagasaki, Japan
Tel	0958197905
Email	gaibushikin@ml.nagasaki-u.ac.jp

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	2020 Year 06 Month 25 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	73
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	2009 Year 01 Month 07 Day
Date of IRB	2009 Year 01 Month 07 Day
Anticipated trial start date	2009 Year 03 Month 01 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 06 Month 24 Day
Last modified on	2020 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046669