UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018769 |
|---|---|
| Receipt number | R000021711 |
| Scientific Title | Investigation of rituximab for candidate of high-risk living-donor renal transplantation |
| Date of disclosure of the study information | 2015/08/24 |
| Last modified on | 2022/02/15 12:49:28 |
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Basic information
Public title
Investigation of rituximab for candidate of high-risk living-donor renal transplantation
Acronym
Investigation of rituximab for candidate of high-risk living-donor renal transplantation
Scientific Title
Investigation of rituximab for candidate of high-risk living-donor renal transplantation
Scientific Title:Acronym
Investigation of rituximab for candidate of high-risk living-donor renal transplantation
Region
| Japan |
Condition
Condition
end-stage chronic renal failure
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of rituximab for candidate of high-risk living-donor renal transplantation including; ABO minor mismach, ABO incompatible, anti-donor antibody, renal failure due to FSGS(Focal segmental glomerulosclerosis), AMR(Antibody mediated rejection), relapse of nephropathy after renal transplantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) disappearance of B cell
2) existence of antibody mediated rejection
3) relapse of FSGS
4) effectiveness for rejection
5) effectiveness for relapsing nephropathy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administration of rituximab before/after living-donor renal transplantation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) ABO minor mismach
2) ABO incompatible
3) with anti donor antibody
4) renal failure due to FSGS
5) antibody mediated rejection
6) relapsing nephropathy
Key exclusion criteria
1) excluding 1)-4), 6) (see above)
2) impertinent recipient for this study assessed by main/co-scholar
3) without concensus of recipient
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Motoo |
| Middle name | |
| Last name | Araki |
Organization
Okayama University Hospital
Division name
Department of Urology
Zip code
7008558
Address
Shikata-cho 2-5-1, Kita-ku, Okayama, Japan
TEL
086-235-7287
motoosh@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Nishimura |
Organization
Okayama University Hospital
Division name
Department of Urology
Zip code
7008558
Address
Shikata-cho 2-5-1, Kita-ku, Okayama, Japan
TEL
086-235-7287
Homepage URL
shingo0414@gmail.com
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Comittee of Okayama University Hospital
Address
Shikata-cho 2-5-1, Kita-ku, Okayama, Japan
Tel
086-235-6503
mae6605@adm.okayama-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
| 2015 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/viewer.html?pdfurl=https%3A%2F%2Fwww.lib.okayama
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/iju.14382
Number of participants that the trial has enrolled
76
Results
There were 59 patients in the rituximab group and 17 in the non-rituximab group. The estimated glomerular filtration rate did not differ significantly between groups until 24 months after transplantation. Cytomegalovirus clinical symptoms , including fever over 38 degree and gastrointestinal symptoms , and the 5-year survival rates of death-censored graft loss did not differ significantly between groups.
Results date posted
| 2022 | Year | 02 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of these, 60 were in the Rit group, and 17 were inthe non-Rit group. Between the two groups, there were significant dif-ferences in age, proportions ofABO-compatible, ABO minor mismatch, ABO major mismatch and DSA-positive patients and in thepresence of a cross-reactive group.However, no statistically significant differences wereobserved in other variables including sex, FSGS, percentage of CMV-seronegative recipients of renal allografts from CMV-seropos-itive donors and percentage ofCMV-seronegative recipients of renal allografts from CMV-seronegative donors.
Participant flow
In addition to the immunosuppression protocol of the non-Rit group, the Rit group received a dose of Rit 200 mg/body on day-14 in cases of ABO major mismatch, DSA-positive and FSGS, and on day-6 in cases of ABO minor mismatch.
Adverse events
There was no significant difference in the incidence ofCMV antigenemia>5 , CMV clinicalsymptoms including fever over 38 C and gastrointestinal symptoms, G-CSF administration , and acute rejection.
Outcome measures
The aim of the present study was to analyze the effect oflow-dose Rit (200 mg/body) as induction therapy in living-donor renal transplantation and its impact on CMV infection.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2015 | Year | 08 | Month | 23 | Day |
Last modified on
| 2022 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021711
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