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
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
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
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
