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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004071
Receipt No. R000004525
Scientific Title Long-term therapeutic effect of pioglitazone on chronic kidney disease (CKD)
Date of disclosure of the study information 2010/08/20
Last modified on 2010/08/19

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Basic information
Public title Long-term therapeutic effect of pioglitazone on chronic kidney disease (CKD)
Acronym Long-term treatment of CKD by pioglitazone.
Scientific Title Long-term therapeutic effect of pioglitazone on chronic kidney disease (CKD)
Scientific Title:Acronym Long-term treatment of CKD by pioglitazone.
Region
Japan

Condition
Condition chronic kidney disease (CKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the long-term proteinuria-reducing and reno-protective effect of pioglitazone on non-diabetic chronic kidney disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Inhibition of deterioration in renal function (serum creatinine, estimated GFR)
Key secondary outcomes Decrease in levels of proteinuria

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients of intervention group are treated with pioglitazone orally from the dose of 15mg/day, increasecd to the continuous dose of 15-45mg/day within one month, and continued for 3 years. The efficacy and side effects are evaluated.
Interventions/Control_2 Patients of control group are treated with pioglitazone dipyridamole orally from the dose of 150mg/day, increasecd to the continuous dose of 300mg/day within one month, and continued for 3 years. The efficacy and side effects are compared with intervention group.
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
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Non-diabetic chronic kidney disease with proteinuria of 0.3g/day (1+ by test tape) or more.
Key exclusion criteria 1. Chronic renal failure with serum creatinine level above 3.0 mg/dl.
2. Severe liver dysfunction.
3. Severe edema or chronic heart failure.
4. Past history of allergy against pioglitazone.
5. Pregnant or breast feeding patients.
6. Patients with ongoing steroid therapy.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroo Kumagai
Organization National Defense Medical College
Division name Department of Nephrology
Zip code
Address 3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Oda
Organization National Defense Medical College
Division name Department of Nephrology
Zip code
Address 3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan
TEL 04-2995-1609
Homepage URL
Email takashio@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Funding Source
Organization None
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 防衛医科大学校病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 20 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 Preinitiation
Date of protocol fixation
2010 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2014 Year 10 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2015 Year 01 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 19 Day
Last modified on
2010 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004525

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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