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
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
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
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
