UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of calcium and sodium polystyrene sulfonate on mineral and bone metabolism in pre-dialysis patients with hyperkalemia
Title of the study (Brief title)	Effects of polystyrene sulfonate on mineral and bone metabolism
Region	Japan

Condition
Condition	pre-dialysis CKD patients
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy and difference of equal doses of oral CPS and SPS on serum potassium levels as well as serum Ca, phosphate (P), sodium, magnesium (Mg), and intact parathyroid hormone (iPTH) values. Further, we explored the plasma human natriuretic peptide (hANP) levels to determine whether SPS could induce sodium-associated volume overload in these patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of potassium, calcium, and magnesium levels
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
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 polystyrene sulfonate (SPS) 15g 4weeks
Interventions/Control_2	calcium polystyrene sulfonate (CPS) 15g 4weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	eGFR<30ml/min, serum potassium level>5.0mmol/l
Key exclusion criteria	We excluded patients who were already given PSs for hyperkalemia, and diagnosed with acute kidney injury, liver injury, or patients in the perioperative period.
Target sample size	40

Research contact person
Name of lead principal investigator	Kei Fukami
Organization	Kurume University
Division name	Division of Nephrology, Department of Medicine
Address	67 Asahi-machi, Kurume city, Fukuoka, Japan
TEL	0942-35-3311
Email	fukami@med.kurume-u.ac.jp

Public contact
Name of contact person	Kei Fukami
Organization	Kurume University
Division name	Division of Nephrology, Department of Medicine
Address	67 Asahi-machi, Kurume city, Fukuoka, Japan
TEL	0942-35-3311
Homepage URL
Email	fukami@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	non
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 31 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	2016 Year 04 Month 17 Day
Last modified on	2016 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025316