UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040875
Receipt number R000046669
Scientific Title Effect of telmisartan on patients with renal dysfunction
Date of disclosure of the study information 2020/06/25
Last modified on 2020/06/24 00:18:54

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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 or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046669


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name