UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000492 |
|---|---|
| Receipt number | R000000597 |
| Scientific Title | Concurrent Treatment of Cardiovascular Disease in Peritoneal Dialysis (PD) patients. Multi-center Randomized Clinical Study with Aldosterone blockade (spironolactone) and Angiotensin Receptor Blocker (ARB) or Angiotensin-Converting-Enzyme Inhibitor (ACEI). |
| Date of disclosure of the study information | 2006/10/01 |
| Last modified on | 2012/03/21 10:07:04 |
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Basic information
Public title
Concurrent Treatment of Cardiovascular Disease in Peritoneal Dialysis (PD) patients. Multi-center Randomized Clinical Study with Aldosterone blockade (spironolactone) and Angiotensin Receptor Blocker (ARB) or Angiotensin-Converting-Enzyme Inhibitor (ACEI).
Acronym
MCS/AA
Scientific Title
Concurrent Treatment of Cardiovascular Disease in Peritoneal Dialysis (PD) patients. Multi-center Randomized Clinical Study with Aldosterone blockade (spironolactone) and Angiotensin Receptor Blocker (ARB) or Angiotensin-Converting-Enzyme Inhibitor (ACEI).
Scientific Title:Acronym
MCS/AA
Region
| Japan |
Condition
Condition
End-Stage Renal Disease (ESRD) and Cardio-Vascular Disease (CVD)
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the clinical effects of concurrent administration of spironolactone with ARB or ACEI treatment to prevent cardiovascular complications in the patients treated with CAPD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Parameters of CVD, occurrence and/or augmentation of the other complications in peritoneal dialysis (PD) patients
Key secondary outcomes
residual renal functional examination, peritoneal functional examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Spironolactorne
Interventions/Control_2
No Spironolactorne
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Should be included all; NYHA I or II, continuing PD treatment less than 5 years, taken one of ARB or ACEI more than 3 months at least, and registration by the patients themselves
Key exclusion criteria
Should be excluded even if one of them would be positive; Patients under 18, older than 80. Patients with anemia whose Hb is less than 9 g/dl. Patients treated for more than 5 years after initiation of dialysis. Patients with heart failure of NYHA III, IV. Patients with pregnancy or the suspected. Patients treated with acid-base fluid dialysis.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Ito |
Organization
Nagoya University
Division name
Nephrology and Renal Replacement Therapy
Zip code
Address
65 Tsurumai, Showaku, Nagoya City, Aichi prefecture, Japan
TEL
052(744)2205
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Ito |
Organization
Nagoya University
Division name
Nephrology and Renal Replacement Therapy
Zip code
Address
65 Tsurumai, Showaku, Nagoya City, Aichi prefecture, Japan
TEL
052-744-2205
Homepage URL
yasuito@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University, Nephrology and Renal Replacement Therapy.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2006 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
If side effect of gynecomastia occurs, spironolactone can be changed to Eplerenon. (This is approved by IRB Nagoya University on Jan.21, 2008)
Management information
Registered date
| 2006 | Year | 09 | Month | 21 | Day |
Last modified on
| 2012 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000597
