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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003206
Receipt No. 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

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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
Email

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
Email ym704@surg1.med.kyushu-u.ac.jp

Sponsor
Institute Department of Surgery and Oncology
Graduate School of Medical Sciences
Kyushu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003865

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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