UMIN-CTR Clinical Trial

Basic information
Public title	Current status of polypharmacy in patients with chronic kidney disease
Acronym	Current status of polypharmacy in patients with chronic kidney disease
Scientific Title	Current status of polypharmacy in patients with chronic kidney disease
Scientific Title:Acronym	Current status of polypharmacy in patients with chronic kidney disease
Region	Japan

Condition
Condition	Chronic kidney disease(CKD)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of polypharmacy on patients with chronic kidney disease (CKD)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacokinetic and psychological effects of polypharmacy on CKD patients
Key secondary outcomes	Effects of improvement of polypharmacy on kidney function of CKD patients

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	95 years-old >=
Gender	Male and Female
Key inclusion criteria	CKD patients who are regularly prescribed medication in our hospital
Key exclusion criteria	Patients complicated with serious diseases such as malignancy, heart failure (NYHA III degrees or more), hematological disorder, and liver cirrhosis
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Michio Middle name Last name Kuwahara
Organization	Saitama Tsukinomori Clinic
Division name	Division of Nephrology
Zip code	339-0012
Address	366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
TEL	048-792-1811
Email	kuwahara@k-naika-cl.jp

Public contact
Name of contact person	1st name Matsukura Middle name Last name Matsukura
Organization	Saitama Tsukinomori Clinic
Division name	Division of Pharmacy
Zip code	339-0012
Address	366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
TEL	048-792-1811
Homepage URL
Email	matsukura@k-naika-cl.jp

Sponsor
Institute	Saitama Tsukinomori Clinic
Institute
Department

Funding Source
Organization	Saitama Tsukinomori Clinic
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethics committee of Saitama Tsukinomori Clinic
Address	366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
Tel	0487921811
Email	hayama@k-naika-cl.jp

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	2017 Year 11 Month 27 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	75
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	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Date of IRB	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

CKD patients are known to be prescribed multiple drugs. This study will clarify the influence of pharmacokinetic and psychological effects and whether decreasing prescribed medication improve kidney function. The results of this study were presented at the Japanese Society for Dialysis Therapy and the Saitama Society for Dialysis Therapy. However, because the pharmacist in charge retired, it became difficult to continue the research.

Management information
Registered date	2017 Year 11 Month 27 Day
Last modified on	2021 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034397