UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013948
Receipt number R000016218
Scientific Title Effects of contrast media for residual renal function in peritoneal dialysis patients.
Date of disclosure of the study information 2014/05/20
Last modified on 2017/01/01 15:15:12

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Basic information

Public title

Effects of contrast media for residual renal function in peritoneal dialysis patients.

Acronym

Effects of RCM on RRT in PD

Scientific Title

Effects of contrast media for residual renal function in peritoneal dialysis patients.

Scientific Title:Acronym

Effects of RCM on RRT in PD

Region

Japan


Condition

Condition

End-Stage Renal Disease (ESRD)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to investigate the effects of administration of radio contrast media on residual renal function in stable PD patients.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

1. residual renal function at 24-48 h. after administration of radio contrast media
2. residual renal function at 2-4 weeks after administration of radio contrast media

Key secondary outcomes

1. residual renal function at 6 month after administration of radio contrast media
2. effects of usage of fluid administration
3. effects of amount of radio contrast media
4. effects of residual renal function at administration of radio contrast media



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


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who are medically required to receive contrast media. (The decision on the amount of contrast media administered in the individual patient is based on clinical requirements.)
The patients who have no history of allergy against contrast media
PD patients with urine volume >100mL/day

Key exclusion criteria

allergy against contrast media
severe hyperthyroidism
pregnancy or possibility of pregnancy
hybrid (PD+HD) therapy
less than 20 y.o.
poor patient compliance

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiko Ito

Organization

Nagoya University

Division name

Nephrology and Renal Replacement Therapy

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

TEL

052-744-2205

Email

yasuito@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashi Mizuno

Organization

Nagoya University

Division name

Nephrology and Renal Replacement Therapy

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

TEL

052-744-2205

Homepage URL


Email

mmizu@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Nagoya University, Nephrology and Renal Replacement Therapy

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


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

安城更生病院(愛知県) Anjo Kosei Hospital
大垣市民病院(岐阜県) Ogaki Municipal Hospital
岡崎市民病院(愛知県) Okazaki City Hospital
岡山大学病院(岡山県) Okayama University Hospital
岡山済生会総合病院(岡山県)Okayama Saiseikai General Hospital
海南病院(愛知県) Kainan Hospital
春日井市民病院(愛知県) Kasugai Municipal Hospital
京都民医連病院(京都府) Kyoto Min-iren Chuo Hospital
九州大学病院(福岡県) Kyusyu University Hospital
倉敷中央病院(岡山県) Kurashiki Central Hospital
慶応義塾大学(東京都) Keio University Hospital
江南厚生病院(愛知県) Konan Kosei Hospital
埼玉医科大学病院(埼玉県)Saitama Medical University Hospital
産業医大病院(福岡県) University of Occupational and Environmental Health
島根大学(島根県) Shimane University Hospital
順天堂大学病院(東京都) Juntendo University Hospital
聖路加国際病院(東京都) St. Luke's International Hospital
大雄会第一病院(愛知県) Daiyukai Dai-ichi Hospital
中部労災病院(愛知県) Chubu Rosai Hospital
東濃厚生病院(岐阜県) Tono Kosei Hospital
豊田厚生病院(愛知県) Toyota Kosei Hospital
名古屋共立病院(愛知県) Nagoya Kyouritu Hospital
成田記念病院(愛知県) Narita Memorial Hospital
長崎大学病院(長崎県) Nagasaki University Hospital
新潟県立新発田病院(新潟県) Niigata Preferctural Shibata Hospital
新潟大学医歯学総合病院(新潟県) Niigata University Medical & Dental Hospital
半田市民病院(愛知県) Handa City Hospital
福島県立医科大学病院(福島県)Fukushima Medical University Hospital
藤田保健衛生大学病院(愛知県)Fujita Health University Hospital
南生協病院(愛知県) Minami seikyo Hospital
宗像医師会病院(福岡県) Munakata Medical Association Hospital
市立四日市病院(三重県) Yokkaichi Municipal Hospital
名古屋大学病院(愛知県) Nagoya University Hospital


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 20 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


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

2011 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2016 Year 06 Month 30 Day

Date of closure to data entry

2016 Year 06 Month 30 Day

Date trial data considered complete

2016 Year 11 Month 30 Day

Date analysis concluded

2016 Year 11 Month 30 Day


Other

Other related information

Observation Study


Management information

Registered date

2014 Year 05 Month 13 Day

Last modified on

2017 Year 01 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016218


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name