UMIN-CTR Clinical Trial

Public title

Effects of circulating myostatin on skeletal muscle mass in patients undergoing peritoneal dialysis

Acronym

Circulating myostatin in patients undergoing peritoneal dialysis

Scientific Title

Effects of circulating myostatin on skeletal muscle mass in patients undergoing peritoneal dialysis

Scientific Title:Acronym

Circulating myostatin in patients undergoing peritoneal dialysis

Region

Japan

Condition

Endstage kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine the association between serum myostatin level and skeletal muscle mass in patients undergoing peritoneal dialysis

Basic objectives2

Others

Basic objectives -Others

This is a cross-sectional study examining the association between serum myostatin level and skeletal muscle mass in patients undergoing peritoneal dialysis. Among the patients who was registered to Fukuoka Peritoneal Dialysis Registry in December 2011, patients who received frozen serum collection at Kyushu University are recruited in the present study. We measures serum myostatin level using the frozen sera from the patients by commercially available ELISA kits. We also record clinical information related to peritoneal dialysis from the medical records. .

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Serum myostatin level

Key secondary outcomes

Skeletal muscle mass

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Outpatients who received peritoneal dialysis treatment between December 2011 and August 2015 at Kyushu University hospital

Key exclusion criteria

Patients who do not have frozen serum

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhiko Tsuruya

Organization

Kyushu University

Division name

Department of Integrated Therapy for Chronic Kidney Disease

Zip code

Address

3-1-1 Maidashi, Higashi-Ku, Fukuoka, Japan

TEL

092-642-5843

Email

tsuruya@intmed2.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shunsuke Yamada

Organization

Kyushu University

Division name

Department of Medicine and Clinical Science

Zip code

Address

3-1-1 Maidashi, Higashi-Ku, Fukuoka, Japan

TEL

092-642-5843

Homepage URL

Email

ana65641@nifty.com

Institute

Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University

Institute

Department

Personal name

Organization

Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

26-223

Org. issuing International ID_1

Activities of Center for Clinical and Translational Research, Kyushu University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

09

Month

21

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Multivariable analyses showed that serum myostatin level was positively associated with skeletal muscle mass and use of vitamin D receptor activators. By contrast, serum myostatin level was negatively associated with higher age and female gender in patients undergoing peritoneal dialysis.

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

04

Month

19

Day

Date of IRB

Anticipated trial start date

2015

Year

09

Month

21

Day

Last follow-up date

2015

Year

10

Month

12

Day

Date of closure to data entry

2015

Year

10

Month

20

Day

Date trial data considered complete

2015

Year

10

Month

25

Day

Date analysis concluded

2015

Year

11

Month

30

Day

Other related information

Among the patients who was registered to Fukuoka Peritoneal Dialysis Registry in December 2011, patients who received frozen serum collection at Kyushu University are recruited in the present study. We measures serum myostatin level using the frozen sera from the patients by commercially available ELISA kits. We also record clinical information related to peritoneal dialysis from the medical records. Clinical information includes age, sex, dialysis vintage, underlying kidney disease, serum biochemical parameters (calcium, phosphate, parathyroid hormone, albumin, urea nitrogen, creatinine), renal and peritoneal creatinine clearance, renal and peritoneal urea clearance, use of medications (phosphate binder, vitamin D receptor activator, cinacalcet, and glucocorticoid), and lean body mass. The factors related to serum myostatin level was determined by linear regression analyses.

Registered date

2015

Year

09

Month

21

Day

Last modified on

2016

Year

02

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021973