UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001126 |
|---|---|
| Receipt number | R000001362 |
| Scientific Title | An open label multi facilities cooperation randomized control trial to verify renoprotective effects of pioglitazone therapy in diabetic nephropathy |
| Date of disclosure of the study information | 2008/04/30 |
| Last modified on | 2022/04/06 10:55:54 |
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Basic information
Public title
An open label multi facilities cooperation randomized control trial to verify renoprotective effects of pioglitazone therapy in diabetic nephropathy
Acronym
Pioglitazone Multicenter Intervention Clinical trial in Hospital of Tohoku region Improving Nephropathy, Oxidative stress, Kidney injury, Urinary albumin excretions (Pio-Michinoku study)
Scientific Title
An open label multi facilities cooperation randomized control trial to verify renoprotective effects of pioglitazone therapy in diabetic nephropathy
Scientific Title:Acronym
Pioglitazone Multicenter Intervention Clinical trial in Hospital of Tohoku region Improving Nephropathy, Oxidative stress, Kidney injury, Urinary albumin excretions (Pio-Michinoku study)
Region
| Japan |
Condition
Condition
Type 2 diabetic nephropathy patients with chronic kidney disease (CKD)
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the renoprotective effects of pioglitazone in diabetic nephropathy.The purpose of this study was to investigate whether pioglitazone inhibits imflammation and oxidative stresses more potently than other hypoglycemic agents under blockade of RAS and exerts renoprotection in type 2 diabetic nephropathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Estimated GFR decrease in 50% or more, increase of serum creatinine level to 3mg/dl or more, changes of urinary albumin excretion
Key secondary outcomes
Cardiovascular event: Appearance of disease of total death, nonfatal myocardial infarction (The asymptomatic cardiac infarction is included), and apoplexy, cerebral infarction, cardiac failure (BNP>1000pg/ml), and the serious illness edema
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
This study is a prospective randomized control trial. The entry period of this study is one year. Subjects were type 2 diabetics with nephropathy, taking RAS inhibitors. The patients were randomly assigned to two groups, a pioglitazone group (7.5 mg/day or 15 mg/day) and other hypoglycemic agents group. Pioglitazone can be properly increased to 30mg/day when the anti-hyperglycemic effect is insufficient.
Interventions/Control_2
Blood pressure, body weight, hemoglobin A1c (HbA1c), serum creatine, serum lipids, the plasma and urinary levels of monocyte chemoattractant protein (MCP)-1, interleukin-6 (IL-6) and, urinary albumin excretion (albumin to creatinine ratio: ACR) and urinary excretions of 8-hydroxydeoxyguanosine (8-OHdG) were determined before (baseline levels) and after the treatment for 6 months , 12 months and 24 months.. We collected fasting blood and first urine samples in early morning.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects enrolled in the present study were type 2 diabetic out-patients with nephropathy, who visit our hospitals and fulfilled the following criteria:1) Mild or moderate hyperglycemia, defined as the HbA1c of 6.0-7.9 %. 2) Use of RAS inhibitors, such as an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II type-1 receptor blocker (ARB), for at least six months. 3) A urinary albumin-to-creatinine ratio (ACR) higher than 30 (mg/mgCr) (stage of diabetic nephropathy: stage II and higher).4) Not severe hypertension (blood pressure < 160/110 mmHg)
Key exclusion criteria
1) A serum creatinine (Cr) level is more than 2.5 (mg/dl) and existence of hematuria.2) Patient who has received continuous dialysis.3) Severe diabetic complications such as retinal hemorrhage, neuropathy, and so on.4) Existence of severe hepatic damages, and cerebrovascular disorders including heart failure.5) Severe hypertension (BP>160/110 mmHg)6) Patients who judged that physician in charge is improper.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Sadayoshi |
| Middle name | |
| Last name | Ito |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Nephrology, Rndocrinology and Vascular Medicine Department of Internal Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7166
ogawa-s@hosp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University Hospital
Division name
Division of Nephrology, Endocrinology and Hypertension
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7166
Homepage URL
http://www.pioms.jp/
ogawa-s@hosp.tohoku.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Trust accounting money
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574 Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2008 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
http://www.pioms.jp/
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
Completed
Date of protocol fixation
| 2008 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2008 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 22 | Day |
Last modified on
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001362
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