UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Rituximab administration for chronic antibody-mediated rejection after kidney transplantation
Title of the study (Brief title)	Rituximab administration for chronic antibody-mediated rejection after kidney transplantation
Region	Japan

Condition
Condition	Antibody-mediated rejection after kidney transplantation
Classification by specialty	Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study investigates the efficiency and safety of rituximab administration for a patient with antibody-mediated rejection after kidney transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in renal function at 6 months
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rituximab administration Rituximab 375 mg/m2 (maxium dose 500mg)/week x 2 dose
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	18 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	The patient who suffer from antibody-mediated rejection after kidney transplantation
Key exclusion criteria	The patient who is judged by the patient's physician as unsuitable for participation in the study
Target sample size	1

Research contact person
Name of lead principal investigator	Akihiko Matsuda
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Nephrology and Hypertension
Address	1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL	049-228-3604
Email	akihikom@saitama-med.ac.jp

Public contact
Name of contact person	Akihiko Matsuda
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Nephrology and Hypertension
Address	1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL	049-228-3604
Homepage URL
Email	akihikom@saitama-med.ac.jp

Sponsor
Institute	Department of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Department of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical 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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 14 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 08 Month 14 Day
Anticipated trial start date	2015 Year 08 Month 14 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2018 Year 09 Month 30 Day
Date trial data considered complete	2018 Year 09 Month 30 Day
Date analysis concluded	2018 Year 09 Month 30 Day

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

Management information
Registered date	2015 Year 08 Month 06 Day
Last modified on	2019 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021488