UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012443 |
|---|---|
| Receipt number | R000014483 |
| Scientific Title | Differential intervention of sodium polystyrene sulfonate versus calcium polystyrene sulfonate in patients with chronic kidney disease and hyperkalemia |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2018/12/04 16:10:25 |
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Basic information
Public title
Differential intervention of sodium polystyrene sulfonate versus calcium polystyrene sulfonate in patients with chronic kidney disease and hyperkalemia
Acronym
Differential intervention of sodium polystyrene sulfonate versus calcium polystyrene sulfonate in patients with chronic kidney disease and hyperkalemia
Scientific Title
Differential intervention of sodium polystyrene sulfonate versus calcium polystyrene sulfonate in patients with chronic kidney disease and hyperkalemia
Scientific Title:Acronym
Differential intervention of sodium polystyrene sulfonate versus calcium polystyrene sulfonate in patients with chronic kidney disease and hyperkalemia
Region
| Japan |
Condition
Condition
Chronic kidney disease with hyperkalemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of sodium polystyrene sulfonate versus calcium polystyrene sulfonate in patients with chronic kidney disease and hyperkalemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum potassium level
Key secondary outcomes
1)Serum bicarbonate level
2)Arteriosclerosis-related
examination (coronary calcification score, and pulse wave velocity)
3)Insulin resistant (HOMA-R)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sodium polystyrene sulfonate
Interventions/Control_2
Calcium polystyrene sulfonate
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
Patients who meets all the following standards
1)Patients with hyperkalemia(serum potassium is 5.5mEq/L or more) or receiving ion exchange resin for hyperkalemia
2)Outpatient
3)Patients with chronic kidney disease(stage G3-G5)
4)Patients over 20 years old at the time of giving consent
5)Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial
Key exclusion criteria
Patients who corresponds to either of the following cannot participate in this clinical study
1)Patients on dialysis
2)Patients receiving oral hypoglycemic agents that might influence the insulin resistance (thiazolidine, biguanide, DPP-4 inhibitors, and drug combination comprising these component), insulin preparation, or GLP-1 receptor agonists
3)Patients who are allergic to targeted medication
4)Patients with intestinal obstruction
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Machiko Oka |
Organization
Shonan Kamakura General Hospital
Division name
Dept. of Nephrology, Immunology and Vascular Medicine
Zip code
Address
1370-1 Okamoto, Kamakura Kanagawa 247-8533
TEL
0467-46-1717
machiko.oka@tokushukai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Machiko Oka |
Organization
Shonan Kamakura General Hospital
Division name
Dept. of Nephrology, Immunology and Vascular Medicine
Zip code
Address
1370-1 Okamoto, Kamakura Kanagawa 247-8533
TEL
0467-46-1717
Homepage URL
machiko.oka@tokushukai.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
湘南鎌倉総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | 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
| 2013 | Year | 11 | Month | 29 | Day |
Last modified on
| 2018 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014483
