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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012443
Receipt No. 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

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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
Email 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
Email machiko.oka@tokushukai.jp

Sponsor
Institute Shonan Kamakura General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014483

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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