UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035414
Receipt number R000040349
Scientific Title The effect of calcimimetics on complications of chronic kidney disease
Date of disclosure of the study information 2018/12/30
Last modified on 2024/02/15 16:24:25

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Basic information

Public title

The effect of calcimimetics on complications of chronic kidney disease

Acronym

The effect of calcimimetics on complications of chronic kidney disease

Scientific Title

The effect of calcimimetics on complications of chronic kidney disease

Scientific Title:Acronym

The effect of calcimimetics on complications of 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

Examination of the effect of calcimimetics on complications of CKD patients (e.g., bone and mineral metabolism factor, bone mineral density, parathyroid enlargement, left ventricular hypertrophy)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Investigation of the effect of calcimimetics on bone and mineral metabolism factor, bone density, parathyroid enlargement in CKD patients

Key secondary outcomes

Effects of calcimimetics on cardiac function and bone metabolism markers in 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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Chronic kidney disease patients who are visiting our hospital regularly

Key exclusion criteria

Patients complicated with serious diseases such as malignancy, heart failure (NYHA III degrees or more), 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 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan

TEL

0487921811

Email

kuwahara@k-naika-cl.jp


Public contact

Name of contact person

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

0487921811

Homepage URL


Email

kuwahara@k-naika-cl.jp


Sponsor or person

Institute

Saitama Tsukinomori Clinic

Institute

Department

Personal name



Funding Source

Organization

Saitama Tsukinomori Clinic

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

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

2018 Year 12 Month 30 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

32

Results

Etelcalcetide was administered to 32 hemodialysis patients with secondary hyperparathyroidism. iPTH, BAP, Osteocalcin, TRACP 5b, and FGF23 decreased significantly, and this decrease persisted.

Results date posted

2024 Year 02 Month 15 Day

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

2018 Year 12 Month 21 Day

Date of IRB

2018 Year 12 Month 21 Day

Anticipated trial start date

2019 Year 01 Month 01 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry

2023 Year 06 Month 30 Day

Date trial data considered complete

2023 Year 07 Month 15 Day

Date analysis concluded

2024 Year 01 Month 15 Day


Other

Other related information

This is an observational study. Of the patients who visited the division of nephrology of the Tsukinomori clinic, all patients fulfilling the selection criteria are targeted.


Management information

Registered date

2018 Year 12 Month 30 Day

Last modified on

2024 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040349


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name