UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052437 |
|---|---|
| Receipt number | R000059850 |
| Scientific Title | Comparison of the effects of sodium zirconium cyclosilicate and cation exchange resin on electrolytes, nutritional status, and metabolic acidosis in hemodialysis patients with hyperkalemia |
| Date of disclosure of the study information | 2023/10/08 |
| Last modified on | 2024/04/08 07:17:17 |
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Basic information
Public title
Comparative study of therapeutic drugs for hyperkalemia in hemodialysis patients
Acronym
Comparative study of therapeutic drugs for hyperkalemia in hemodialysis patients
Scientific Title
Comparison of the effects of sodium zirconium cyclosilicate and cation exchange resin on electrolytes, nutritional status, and metabolic acidosis in hemodialysis patients with hyperkalemia
Scientific Title:Acronym
Comparison of the effects of sodium zirconium cyclosilicate and cation exchange resin on electrolytes, nutritional status, and metabolic acidosis in hemodialysis patients with hyperkalemia
Region
| Japan |
Condition
Condition
End stage kidney disease hyperkalemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effects of cation exchange resin and sodium zirconium cyclosilicate hydrate electrolyte on nutritional status
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum potassium levels before and after switching from cation exchange resin to sodium zirconium cyclosilicate hydrate
Key secondary outcomes
Comparison of electrolyte values before and after switching from cation exchange resin to zirconium sodium cyclosilicate hydrate
Comparison of bicarbonate concentration before and after switching from cation exchange resin to zirconium sodium cyclosilicate hydrate
Comparison of Geriatric Nutritional Risk Index (GNRI) values before and after switching from cation exchange resin to zirconium sodium cyclosilicate hydrate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switched from cation exchange resin to sodium zirconium cyclosilicate (5g once on non-dialysis days) for 12 weeks
Interventions/Control_2
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
Maintenance hemodialysis patients receiving hemodialysis three times a week
Patients undergoing treatment for hyperkalemia with resin
Patients who have obtained written informed consent of their own free will to participate in this study
Key exclusion criteria
Patients allergic to sodium zirconium cyclosilicate hydrate
Patients who are breastfeeding or pregnant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naofumi |
| Middle name | |
| Last name | Ikeda |
Organization
Saitama Sekishinkai Hospital
Division name
Department of Nephrology
Zip code
3501305
Address
2-37-20 Irumagawa Sayama Saitama, Japan
TEL
04-2953-6611
naofumi-ikeda@saitama-sekishinkai.org
Public contact
Name of contact person
| 1st name | Naofumi |
| Middle name | |
| Last name | Ikeda |
Organization
Saitama Sekishinkai Hospital
Division name
Department of Nephrology
Zip code
3501305
Address
2-37-20 Irumagawa Sayama Saitama, Japan
TEL
04-2953-6611
Homepage URL
naofumi-ikeda@saitama-sekishinkai.org
Sponsor or person
Institute
Saitama Sekishinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Saitama Sekishinkai Hospital
Address
2-37-20 Irumagawa Sayama Saitama, Japan
Tel
04-2953-6611
hideyuki-kudou@saitama-sekishinkai.org
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
| 2023 | Year | 10 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059850
| 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 |
