UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038833
Receipt number R000044284
Scientific Title Effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on angiogenesis-related proteins in patients undergoing peritoneal dialysis
Date of disclosure of the study information 2019/12/09
Last modified on 2019/12/09 22:34:33

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Basic information

Public title

Effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on angiogenesis-related proteins in patients undergoing peritoneal dialysis

Acronym

Effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on angiogenesis-related proteins in patients undergoing peritoneal dialysis

Scientific Title

Effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on angiogenesis-related proteins in patients undergoing peritoneal dialysis

Scientific Title:Acronym

Effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on angiogenesis-related proteins in patients undergoing peritoneal dialysis

Region

Japan


Condition

Condition

Chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on the profile of angiogenesis-related proteins in drained dialysate of patients undergoing PD.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

angiogenesis-related proteins in drained dialysate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


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

patients were randomly allocated to sequential treatment with L-PDFs following B/L-PDFs(Group A, n=5) or vice versa (Group B, n=5)

Interventions/Control_2

patients were randomly allocated to sequential treatment with L-PDFs following B/L-PDFs(Group A, n=5) or vice versa (Group B, n=5

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with End-stage kidney disease undergoing peritoneal dialysis

Key exclusion criteria

Younger than 20 years old
Patients undergoing automated peritoneal dialysis.
Patients with peritonitis

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Tetsu
Middle name
Last name Miyamoto

Organization

University of Occupational and Environmental Health

Division name

Kidney Center

Zip code

807-8555

Address

Iseigaoka 1-1, Yahatanishi, Kitakyushu

TEL

093-603-1611

Email

tetsum@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name TETSU
Middle name MIYAMOTO
Last name MIYAMOTO

Organization

University of Occupational and Environmental Health

Division name

Kidney Center

Zip code

807-8555

Address

1-1 Iseigaoka, Yahatanishi

TEL

0936031611

Homepage URL


Email

tetsum@med.uoeh-u.ac.jp


Sponsor or person

Institute

University of Occupational and Environmental Health

Institute

Department

Personal name



Funding Source

Organization

University of Occupational and Environmental Health

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

University of Occupational and Environmental Health

Address

Iseigaoka 1-1, Yahatanishi, Kitakyushu

Tel

093-603-1611

Email

tetsum@med.uoeh-u.ac.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

2019 Year 12 Month 09 Day


Related information

URL releasing protocol

in preparation

Publication of results

Unpublished


Result

URL related to results and publications

in preparation

Number of participants that the trial has enrolled

10

Results

In the 19 angiogenesis-related proteins investigated in this study, the expression of growth related oncogene (GRO, CXCL), which belongs to the CXC chemokine family, decreased significantly after use of the B/L-PDFs compared to the L-PDFs (P=0.04). Patients with short-term dialysis vintage tended to have lower levels of angiogenesis-related protein levels when using the B/L-PDFs (P=0.004).

Results date posted

2019 Year 12 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Four Female, 52-78 yrs old, 4 DM patients

Participant flow

In 24 PD patients in our department, 14 patients with APD were excluded. 10 patients were enrolled and completed whole protocol.

Adverse events

None

Outcome measures

In the 19 angiogenesis-related proteins investigated in this study, the expression of growth related oncogene (GRO, CXCL), which belongs to the CXC chemokine family, decreased significantly after use of the B/L-PDFs compared to the L-PDFs (P=0.04). Patients with short-term dialysis vintage tended to have lower levels of angiogenesis-related protein levels when using the B/L-PDFs (P=0.004).

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 05 Month 07 Day

Anticipated trial start date

2015 Year 05 Month 07 Day

Last follow-up date

2015 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 12 Month 09 Day

Last modified on

2019 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044284


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name