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

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 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


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

Value
https://center6.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