UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042090 |
|---|---|
| Receipt number | R000048030 |
| Scientific Title | A Comparative Study of Improvement of Hyperkalemia by Sodium Zirconium Cyclosilicate Hydrate and Polystyrene Sulfonate Calcium in Chronic Hemodialysis Patients (Multicenter collaborative study) |
| Date of disclosure of the study information | 2020/10/12 |
| Last modified on | 2020/10/12 19:17:03 |
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Basic information
Public title
A Comparative Study of Improvement of Hyperkalemia by Sodium Zirconium Cyclosilicate Hydrate and Polystyrene Sulfonate Calcium in Chronic Hemodialysis Patients (Multicenter collaborative study)
Acronym
A study of improving pre-dialysis hyperkalemia
Scientific Title
A Comparative Study of Improvement of Hyperkalemia by Sodium Zirconium Cyclosilicate Hydrate and Polystyrene Sulfonate Calcium in Chronic Hemodialysis Patients (Multicenter collaborative study)
Scientific Title:Acronym
A study of improving pre-dialysis hyperkalemia
Region
| Japan |
Condition
Condition
End-stage renal disease requiring maintenance hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using randomized controlled trial (RCT) (active drug parallel group comparison study, superiority trial), the aim of this study is to examine the effect of sodium zirconium cyclosilicate hydrate (SZC) on improving pre-dialysis hyperkalemia compared with polystyrene sulfonate calcium (CPS) as a control in patients with poorly controlled pre-dialysis serum potassium levels among those receiving chronic hemodialysis three times per week.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of responders will be compared between the SZC group and CPS group.
Responders: Among pre-dialysis K levels measured four times at the beginning of the week while using the allocated drug, those with serum K levels within the range of >=4.0 mEq/L and <=5.0 mEq/L at least three times will be defined as responders.
Key secondary outcomes
1. We will conduct an intergroup comparison of the amount of change in serum zinc, serum copper, and shunt blood bicarbonate ion concentrations from before to after usage of the allocated drug.
2. We will conduct an intergroup comparison of serum zinc, serum copper, shunt blood bicarbonate ion concentrations, PAC-QOL scores during usage of the allocated drug, and the rate of weight gain in dialysis intervals (=dialysis interval weight gain/ dry weight)
3. Drug side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 zirconium cyclosilicate hydrate: Suspend 5 g in water per day and give 1 once per day on non-dialysis days. The drug administration period is one month.
Interventions/Control_2
Polystyrene sulfonate calcium: As 1 day of polystyrene sulfonate calcium, 15g is divided into three doses given orally after each meal.The drug administration period is one month.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Chronic maintenance hemodialysis patients receiving hemodialysis therapy three times per week
2. Patients with pre-dialysis serum potassium levels of 5.6 mEq/L or higher or receiving treatment for hyperkalemia by potassium adsorbents
3. Patients who personally provided written consent at their own free will to participate in this study after receiving a thorough explanation and providing informed consent
Key exclusion criteria
1. Patients with an allergy to sodium zirconium cyclosilicate hydrate or polystyrene sulfonate calcium
2. Patients with intestinal stenosis or severe constipation
3. Patients who are pregnant or breastfeeding
4. Patients who participated in another clinical trial (study) less than three months prior to commencing the test drug
Grounds for setting the exclusion criteria: 1 - 3 are in consideration of safety and 4 is in consideration of the effect on the efficacy evaluation and safety
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Fujimoto |
Organization
Kanazawa Medical University
Division name
Nephrology
Zip code
920-0293
Address
1-1 Daigaku Uchinada Kahoku District Ishikawa Japan
TEL
076-286-2211
k-2210@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Fujimoto |
Organization
Kanazawa Medical University
Division name
Nephrology
Zip code
920-0293
Address
1-1 Daigaku Uchinada Kahoku District Ishikawa Japan
TEL
076-286-2211
Homepage URL
k-2210@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
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
Kanazawa Medical University
Address
1-1 Daigaku Uchinada Kahoku District Ishikawa Japan
Tel
076-218-8347
tiken@kanazawa-med.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2024 | 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
| 2020 | Year | 10 | Month | 12 | Day |
Last modified on
| 2020 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048030
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