UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007730 |
|---|---|
| Receipt number | R000009104 |
| Scientific Title | A switching trial from calcium polystyrene sulfonate jelly to sodium polystyrene sulfonate dry syrup |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2019/04/18 14:43:15 |
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Basic information
Public title
A switching trial from calcium polystyrene sulfonate jelly to sodium polystyrene sulfonate dry syrup
Acronym
A switching trial of potassium absorption agents
Scientific Title
A switching trial from calcium polystyrene sulfonate jelly to sodium polystyrene sulfonate dry syrup
Scientific Title:Acronym
A switching trial of potassium absorption agents
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the drug adherence of potassium absorption agents.
Basic objectives2
Others
Basic objectives -Others
To survey the changes of clinical data including potassium.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ease of consumption
Carrying condition
Key secondary outcomes
CBC, biochemstiry, urinalysis
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Calcium polystyrene sulfonate jelly
Interventions/Control_2
Sodium polystyrene sulfonate dry syrup
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
mor than S-Cr 1.5 mg/dL
less than S-Cr 6.0 mg/dL
Key exclusion criteria
acute renal failure
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | SHINICHI |
| Middle name | |
| Last name | NISHI |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology and Kidney Center
Zip code
6500017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6500
snishi@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | SHINICHI |
| Middle name | |
| Last name | NISHI |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology and Kidney Center
Zip code
6500017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6500
Homepage URL
snishi@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Nephrology and Kidney Center,
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
donation money for research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Univ. Hospital Clinical Translational Research Cener IRB
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
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
神戸大学大学院医学研究科腎臓内科
腎・血液浄化センター
Division of Nephrology and Kidney Center,
Kobe University Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
http://www.med.kobe-u.ac.jp/kidney/classmb.html
Number of participants that the trial has enrolled
15
Results
adherence of agents
After the change from jelly type potassium absorption agent to dry syrup type potassium absorption agent, a half of patients replied the adherence to agent and carrying of agent improved.
Results date posted
| 2019 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
15outclnic patients with chronic kidney disease
Participant flow
Eight of all patients replied the dry syrup agent could be easily taken and the carrying was better.
Adverse events
none
Outcome measures
adherence to agent
carrying of agent
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
serum potassium
Management information
Registered date
| 2012 | Year | 04 | Month | 12 | Day |
Last modified on
| 2019 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009104
| Research Plan | |
|---|---|
| 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 |
