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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001126
Receipt No. 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 2015/06/08

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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
Middle name
Last name Sadayoshi Ito MD, PhD
Organization Tohoku University Graduate School of Medicine
Division name Division of Nephrology, Rndocrinology and Vascular Medicine Department of Internal Medicine
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7166
Email

Public contact
Name of contact person
1st name
Middle name
Last name Susummu Ogawa MD, PhD
Organization Tohoku University Hospital
Division name Division of Nephrology, Endocrinology and Hypertension
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7166
Homepage URL http://www.pioms.jp/
Email ogawa-s@hosp.tohoku.ac.jp

Sponsor
Institute Graduate School of Medicine, Tohoku University
Institute
Department

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
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

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
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
2015 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001362

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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