UMIN-CTR Clinical Trial

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
Email	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
Email	shingo0414@gmail.com

Sponsor
Institute	Okayama University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021711