UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Differential intervention of sodium polystyrene sulfonate versus calcium polystyrene sulfonate in patients with chronic kidney disease and hyperkalemia
Title of the study (Brief title)	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	Machiko Oka
Organization	Shonan Kamakura General Hospital
Division name	Dept. of Nephrology, Immunology and Vascular Medicine
Address	1370-1 Okamoto, Kamakura Kanagawa 247-8533
TEL	0467-46-1717
Email	machiko.oka@tokushukai.jp

Public contact
Name of contact person	Machiko Oka
Organization	Shonan Kamakura General Hospital
Division name	Dept. of Nephrology, Immunology and Vascular Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 11 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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