UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004071 |
|---|---|
| Receipt number | 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 15:28:35 |
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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
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
takashio@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004525
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
