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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007730
Receipt No. 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

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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
Email 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
Email snishi@med.kobe-u.ac.jp

Sponsor
Institute Division of Nephrology and Kidney Center,
Kobe University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009104

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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