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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021955
Receipt No. R000025316
Scientific Title Effects of calcium and sodium polystyrene sulfonate on mineral and bone metabolism in pre-dialysis patients with hyperkalemia
Date of disclosure of the study information 2016/04/17
Last modified on 2016/04/26

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Basic information
Public title Effects of calcium and sodium polystyrene sulfonate on mineral and bone metabolism in pre-dialysis patients with hyperkalemia
Acronym Effects of polystyrene sulfonate on mineral and bone metabolism
Scientific Title Effects of calcium and sodium polystyrene sulfonate on mineral and bone metabolism in pre-dialysis patients with hyperkalemia
Scientific Title:Acronym Effects of polystyrene sulfonate on mineral and bone metabolism
Region
Japan

Condition
Condition pre-dialysis CKD patients
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and difference of equal doses of oral CPS and SPS on serum potassium levels as well as serum Ca, phosphate (P), sodium, magnesium (Mg), and intact parathyroid hormone (iPTH) values. Further, we explored the plasma human natriuretic peptide (hANP) levels to determine whether SPS could induce sodium-associated volume overload in these patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of potassium, calcium, and magnesium levels
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
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 sodium polystyrene sulfonate (SPS)
15g 4weeks
Interventions/Control_2 calcium polystyrene sulfonate (CPS)
15g 4weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria eGFR<30ml/min, serum potassium level>5.0mmol/l
Key exclusion criteria We excluded patients who were already given PSs for hyperkalemia, and diagnosed with acute kidney injury, liver injury, or patients in the perioperative period.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Fukami
Organization Kurume University
Division name Division of Nephrology, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume city, Fukuoka, Japan
TEL 0942-35-3311
Email fukami@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Fukami
Organization Kurume University
Division name Division of Nephrology, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume city, Fukuoka, Japan
TEL 0942-35-3311
Homepage URL
Email fukami@med.kurume-u.ac.jp

Sponsor
Institute Kurume University
Institute
Department

Funding Source
Organization non
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
2016 Year 04 Month 17 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
2013 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 17 Day
Last modified on
2016 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025316

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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