UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021955 |
|---|---|
| Receipt number | 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 14:12:43 |
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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
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
fukami@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025316
