UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of contrast media for residual renal function in peritoneal dialysis patients.
Title of the study (Brief title)	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	Yasuhiko Ito
Organization	Nagoya University
Division name	Nephrology and Renal Replacement Therapy
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	Masashi Mizuno
Organization	Nagoya University
Division name	Nephrology and Renal Replacement Therapy
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2205
Homepage URL
Email	mmizu@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016218