UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003206 |
|---|---|
| Receipt number | R000003865 |
| Scientific Title | Evaluation of improvement effects of angiotensin II receptor blockers on glycemic and lipid metabolism in renal transplant patients |
| Date of disclosure of the study information | 2011/02/18 |
| Last modified on | 2012/08/20 15:24:55 |
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Basic information
Public title
Evaluation of improvement effects of angiotensin II receptor blockers on glycemic and lipid metabolism in renal transplant patients
Acronym
Evaluation of improvement effects of ARB on glycemic and lipid metabolism in renal transplant patients
Scientific Title
Evaluation of improvement effects of angiotensin II receptor blockers on glycemic and lipid metabolism in renal transplant patients
Scientific Title:Acronym
Evaluation of improvement effects of ARB on glycemic and lipid metabolism in renal transplant patients
Region
| Japan |
Condition
Condition
Stable hypertensive patient who is administering ARB after renal transplant
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare improvement effects of telmisartan and candesartan on serum glucose level and lipid level in hypertensive patients after renal transplant
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum triglyceride level and adiponectin level from baseline to 12 weeks after
Key secondary outcomes
Casual blood pressure, fasting blood glucose, HbA1c, glycoalbumin, fasting insulin, HOMA-IR (calculation from blood glucose level and insulin level), LDL-C, HDL-C, serum creatinine, eGFR (calculation from serum creatinine level), urinary albumin-to-creatinine ratio, adverse event
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Telmisartan-preceding group:
Previous ARB is switched to equivalent amount of telmisartan without washout period and then telmisartan is administered with once-daily dosing for 12 weeks. After 12 weeks telmisartan is switched to equivalent amount of candesartan without washout period and candesartan is administered with once-daily dosing for 12 weeks.
Interventions/Control_2
Candesartan-preceding group:
Previous ARB is switched to equivalent amount of candesartan without washout period and then candesartan is administered with once-daily dosing for 12 weeks. After 12 weeks candesartan is switched to equivalent amount of telmisartan without washout period and telmisartan is administered with once-daily dosing for 12 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patient who passed six months or more after renal transplant and patients to whom the dosages of calcineurin inhibitor (tacrolimus or cyclosporine), antimetabolic drug (mycophenolate mofetil or mizoribine) and steroid are steady
2.Stable hypertensive patient (less than BP 130/80) on antihypertensive with an angiotensin II receptor blocker
3.Gender free, and from 20 years old to less than 75 years old
4.Patient who obtained written informed consent
Key exclusion criteria
1.Ptient with graft loss
2.Patient who has a history of hypersensitivity
3.Patient who is pregnant or a female patient who is expecting to become pregnant
4.Patient with extremely bad secretion of bile (total bilirubin: >= 2.0 mg/dL)
5.Patient who has serious hepatic disorder (GOT or GPT: >= 100 IU/L)
6.Patient who has serious renal disorder (serum creatinine: >= 3.0 mg/dL)
7.Patient with hyperkalemia (K: >= 5.5 mEq/L)
8.Patient who is currently receiving pioglitazone
9.Patient who is currently receiving angiotensin converting enzyme inhibitor
10.Patient who is currently receiving lipid-lowering therapy with fibrate agent
11.Patient who began taking statin within two months before start of the study
12.Patient with whom the physician-in-charge considered inappropriate as a subject of the study
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | hidehisa kitada |
Organization
medical faculty of Kyushu university
Division name
kidney care unit/Department of Surgery and Oncology
Zip code
Address
3-1-1maedashi higasiku fukuokasi
TEL
0926425443
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yoshifumi miura |
Organization
medical faculty of Kyushu university
Division name
Department of Surgery and Oncology
Zip code
Address
3-1-1maedashi higasiku fukuokasi
TEL
0926425443
Homepage URL
ym704@surg1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Oncology
Graduate School of Medical Sciences
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Transplant/Blood Vessel Group
Department of Surgery and Oncology
Graduate School of Medical Sciences
Kyushu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | 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
| 2010 | Year | 02 | Month | 18 | Day |
Last modified on
| 2012 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003865
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