UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062010 |
|---|---|
| Receipt number | R000070950 |
| Scientific Title | A Crossover Trial Comparing CARBOSTAR 2P fo Dialysis and KINDALY Hemodiakysis Agents 5E in Patients on Chronic Maintenance Dialysis |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/06/22 16:16:17 |
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Basic information
Public title
A Crossover Trial Comparing CARBOSTAR 2P fo Dialysis and KINDALY Hemodiakysis Agents 5E in Patients on Chronic Maintenance Dialysis
Acronym
CCKD study
Scientific Title
A Crossover Trial Comparing CARBOSTAR 2P fo Dialysis and KINDALY Hemodiakysis Agents 5E in Patients on Chronic Maintenance Dialysis
Scientific Title:Acronym
A Crossover Trial Comparing CARBOSTAR 2P fo Dialysis and KINDALY Hemodiakysis Agents 5E in Patients on Chronic Maintenance Dialysis
Region
| Japan |
Condition
Condition
Chronic Maintenance Dialysis Patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare this solution with Kindley Dialysis Solution No. AF5, which is adjusted to a K concentration of 2.3 mEq/L, to evaluate its effectiveness in correcting serum potassium levels and electrolyte imbalances. We will also evaluate nutritional status and changes in the patients condition during dialysis as secondary endpoints.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in K Values Before and After Dialysis
Key secondary outcomes
Nutritional Status Assessment. %CGR, nPCR, NRI-JH
Changes in electrolyte concentrations, etc.Pre-dialysis serum Mg level, pre-dialysis serum P level, pre- and post-dialysis serum Ca levels, pre-dialysis intact PTH level, pre-dialysis pH, pre-dialysis PCO2, pre-dialysis HCO3-
Patient condition during dialysis
Blood pressure fluctuations, number of interventions for hypotension, etc.; occurrence of clinical symptoms such as allergic reactions
Dosage of oral and injectable medications
Magnesium oxide preparations, vitamin D3 preparations, calcium carbonate preparations, calcium receptor agonists
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CARBOSTAR 2P for Dialysis
Interventions/Control_2
KINDALY Hemodialysis Agents 5E
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
| 30 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients from whom informed consent can be obtained
Patients undergoing pre-diluted online hemodiafiltration with a replacement fluid volume of 10 L/h or more
Patients undergoing intermittent replacement HDF
Key exclusion criteria
Patients with a history of acetic acid intolerance for whom the use of acetic acid-containing dialysate is not recommended
Patients with severe liver, heart, or lung dysfunction, as determined by the attending physician
Patients presenting with uncontrolled inflammation
Pregnant or breastfeeding patients
Patients deemed unsuitable for participation in this study by the attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | shinya |
| Middle name | |
| Last name | suganuma |
Organization
KIDNEY CLINIC SEGATAYA
Division name
Hemodialysis
Zip code
157-0062
Address
4-21-14,minamikarasuyama,setagaya-ku,tokyo
TEL
03-5969-4976
s.suganuma@jinnaika.com
Public contact
Name of contact person
| 1st name | takamitsu |
| Middle name | |
| Last name | nishizawa |
Organization
KIDNEY CLINIC SETAGAYA
Division name
Clinical Endineer
Zip code
157-0062
Address
4-21-14,minamikarasuyama,setagaya-ku,tokyo
TEL
03-5969-4976
Homepage URL
t.nishizawa@jinnaika.com
Sponsor or person
Institute
KYDNEY CLINIC SETAGAYA,Hemodyalisis,Sinya Suganuma
Institute
Department
Personal name
Funding Source
Organization
Sef-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
Japanese Society for Hemodiafiltraion
Address
3-30,nakazima-cho,naka-ku,hiroshima-sih,hiroshima
Tel
082-243-9191
office@hdf-j.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070950
