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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001017
Receipt No. R000001171
Scientific Title Therapeutic effect of pioglitazone on chronic kidney disease (CKD).
Date of disclosure of the study information 2008/02/27
Last modified on 2010/08/11

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Basic information
Public title Therapeutic effect of pioglitazone on chronic kidney disease (CKD).
Acronym Treatment of CKD by pioglitazone.
Scientific Title Therapeutic effect of pioglitazone on chronic kidney disease (CKD).
Scientific Title:Acronym 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 proteinuria-inhibiting and reno-protective effect of pioglitazone, a PPAR r agonist, 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 Decrease in levels of proteinuria
Key secondary outcomes Inhibition of deterioration in renal function (serum creatinine, estimated-GFR)

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 Numbered container method

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, increased up to 30-45mg/day within one month, and continued for 6 month. The efficacy and side effects are evaluated.
Interventions/Control_2 Patients of control group are treated with dipyridamole orally from the dose of 150mg/day, increased up to 300mg/day within one month, and continued for 6 month. 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
20 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 24

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 04-2995-1609
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

Other administrative information
Date of disclosure of the study information
2008 Year 02 Month 27 Day

Related information
URL releasing protocol
Publication of results Partially published

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 02 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2010 Year 06 Month 01 Day
Date of closure to data entry
2010 Year 09 Month 01 Day
Date trial data considered complete
2010 Year 10 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 02 Month 05 Day
Last modified on
2010 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001171

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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