UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of rituximab in desensitization of preoperative DSA positive patients and postoperative ABMR treatment of DSA positive patients in kidney transplantation
Title of the study (Brief title)	The effect of rituximab in DSA positive kidney transplant recipients
Region	Japan

Condition
Condition	Chronic renal failure
Classification by specialty	Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the effect of rituximab in desensitization of preoperative DSA positive patients and treatment against ABMR with postoperative DSA positive kidney transplant recipients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary endpoint of desensitization: Attenuation of DSA-MFI(Mean fluorescent intensity) 2 and 4 weeks after rituximab administration. Primary endpoint of treatment: Attenuation of DSA-MFI 12 and 24 weeks after rituximab administration
Key secondary outcomes	Secondary endpoint of desensitization: Lymphocyte crossmatch test 2 weeks after rituximab administration and possibility of kidney transplant. Secondary endpoint of treatment: The change of serum Cr.,urinary protein/Cr.ratio, and graft kidney histopathological findings( according to Banff classification)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Preoperaive desensitization for DSA positive patients:After informed consent, patient will be evaluated for adaquacy and recieve the antibody removal by plasmapheresis followed by the first dose of rituximab 375mg/m2 intravenous drip infusion on in house setting. If DSA MFI level decreased lower than 3000 degree, plasmapheresis followed by the second dose rituximab administration will be done 4 weeks after the first dose and kidney transplantation would be performed. If DSA MFI over 3000 degree 2 weeks after the first rituximab administration, plasmapheresis followed by the second dose rituximab would be administrated on 4weeks, and DSA MFI level would be evaluated without kidney transplantation. Administration dose would be adjusted and altered according to bodyweight, age and condition of the patients. Postoperative treatment for ABMR with DSA production: After informed consent, patient will be evaluated for adaquacy and recieve the antibody removal by plasmapheresis followed by the first dose of rituximab 375mg/m2 intravenous drip infusion on in house setting.If DSA MFI level decreased lower than 3,000 degree, plasmapheresis followed by the second dose rituximab administration will be done 4 weeks after the first dose. Administration dose would be adjusted and altered according to bodyweight, age and condition of the patients. Clinical course would be carefully followed, then 12 and 24 weeks after treatment, DSA MFI level would be evaluated and kidney graft biopsy would be performed on 24 weeks.
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	Patients whose pre-kidney transplant lymphocyte crossmatch test were positive(DSA positive) and whose crossmatch test turned positive after kidney transplantation with ABMR. Both gender of patients are acceptable without pregnant and/or possible-pregnant women. Participant age is not limited. All the participants must received written informed consents.
Key exclusion criteria	Exclusion Criteria: Patients with cardiac, pulmonary and hepaic dysfunction and severe bone marrow suppression must be excluded. Hypersensitivity history against rituximab and/or boron, who cannot receive informed consent are also excluded. Patients whomDoctor in charge decided inadequate for participate in this study are excluded. Criteria in which study must be stopped: If the participant would expressed refusal against the study. If the study must be stopped due to the severe adveresed event and/or other reaseons for contraindication for treatment and/or kidney transplantation. If this study itself must be stopped according to the certain reason.
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuhide Saito
Organization	Niigata University
Division name	Division of Urology
Address	1-757, Asahimachi-dori, chuo-ku, Niigata city, 951-8510, JAPAN
TEL	+81-25-227-2289
Email	kazsaito@med.niigata-u.ac.jp

Public contact
Name of contact person	Kazuhide Saito
Organization	Niigata University
Division name	Division of Urology
Address	1-757, Asahimachi-dori, chuo-ku, Niigata city, 951-8510, JAPAN
TEL	+81-25-227-2289
Homepage URL
Email	kazsaito@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	Niigata University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	新潟大学医歯学総合病院

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 21 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 12 Month 25 Day
Anticipated trial start date	2013 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 21 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040261