UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015961
Receipt number R000018565
Scientific Title A Study about Periodic Cooperation Program for Chronic Kidney Disease between Primary Care Physicians and Kidney Specialists
Date of disclosure of the study information 2015/10/01
Last modified on 2015/07/24 10:05:53

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Basic information

Public title

A Study about Periodic Cooperation Program for Chronic Kidney Disease between Primary Care Physicians and Kidney Specialists

Acronym

Utility of Periodic Cooperation Program for Chronic Kidney Disease

Scientific Title

A Study about Periodic Cooperation Program for Chronic Kidney Disease between Primary Care Physicians and Kidney Specialists

Scientific Title:Acronym

Utility of Periodic Cooperation Program for Chronic Kidney Disease

Region

Japan


Condition

Condition

Chronic Kidney Disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

No reports have explored the utility of periodic cooperation program for chronic kidney disease between primary care physicians and kidney specialists using a team approach. We therefore retrospectively examine the utility of our periodic cooperation program.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Estimated glomerular filtration rate, home blood pressure

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1 Patients who had a diagnosis of chronic renal disease
2 Patients who received a nutrition education
3 Patients who measure home blood pressure
4 Patients who visit our hospital regularly for the cooperation program between primary care physicians and kidney specialists
5 Patients who do urine and a blood test for every cooperation in our hospital

Key exclusion criteria

1 Patients who judged to be inadequate as analysis subject by a physician

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuyoshi Okada

Organization

Nihon University School of Medicine

Division name

Division of Nephrology, Hypertension and Endcrinology

Zip code


Address

30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan

TEL

03-3972-8111

Email

kokada@med.nihon-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kimitoshi kato

Organization

Nihon University School of Medicine

Division name

Clinical research center

Zip code


Address

30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan

TEL

3972-8111

Homepage URL


Email

kimitoshi.kato@nihon-u.ac.jp


Sponsor or person

Institute

Division of Nephrology, Hypertension and Endcrinology, Nihon University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Nephrology, Hypertension and Endcrinology, Nihon University School of Medicine

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


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



Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2014 Year 12 Month 16 Day

Date of IRB


Anticipated trial start date

2015 Year 02 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

We investigate the following items.
1 Patients information from letter of introduction and the an interview: age, sex, diagnosis, a medical history, prescription contents
2 Urine and blood tests: urinary protein excretion rate, urinary alubumin excretion rate, serum creatinine, estimated glomerular filtration rate, hemoglobin A1c, LDL-cholesterol, HDL-cholesterol, triglyceride, non-HDL cholesterol, uric acid, potassium, hemoglobin, calcium in case with prescription of vitamin D or calcium-containing agent, iron, unbound iron binding capacity, and ferritin in case with anemia
3 blood pressure at consulting room and home
4 Imaging studies: abdominal echography, ultrasonography of carotid artery, ultrasonic cardiography, head MRI and other imaging studies if needed
5 Others: Prescription contents for change, practice period, periodic visit rate for cooperation


Management information

Registered date

2014 Year 12 Month 15 Day

Last modified on

2015 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018565