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Prospective, multicenter, pilot study to evaluate the effectiveness of biomarkers for early diagnosis of acute rejection in de novo renal transplant recipients

Status Approved

First Submitted Date

2021/02/19
Registered Date

2021/03/11
Last Updated Date

2021/06/24

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005991
Unique Protocol ID	KNUH 2018-02-012-001
Public/Brief Title	Evaluation of effectiveness of biomarkers for early diagnosis of acute rejection in renal transplant recipients
Scientific Title	Prospective, multicenter, pilot study to evaluate the effectiveness of biomarkers for early diagnosis of acute rejection in de novo renal transplant recipients
Acronym	ACROBIOMARKER
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KNUH 2018-02-012-001
Approval Date	2018-03-27
Institutional Review Board Name	Institutional Review Board of Kyungpook National University Hospital
Institutional Review Board Address	130, Dongdeok-ro, Jung-gu, Daegu
Institutional Review Board Telephone	053-200-5430
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Chan-Duck Kim
Title	Professor
Telephone	+82-53-200-5550
Affiliation	Kyungpook National University Hospital
Address	130, Dongdeok-ro, Jung-gu, Daegu
Contact Person for Public Queries
Name	Jeong-Hoon Lim
Title	Associate professor
Telephone	+82-53-200-5550
Affiliation	Kyungpook National University Hospital
Address	130, Dongdeok-ro, Jung-gu, Daegu
Contact Person for Updating Information
Name	Jeong-Hoon Lim
Title	Associate professor
Telephone	+82-53-200-5550
Affiliation	Kyungpook National University Hospital
Address	130, Dongdeok-ro, Jung-gu, Daegu

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 6
Overall Recruitment Status	Completed
Date of First Enrollment	2018-05-17 Actual
Target Number of Participant	40
Primary Completion Date	2020-08-31 , Actual
Study Completion Date	2020-10-31 , Actual
Name of Study	Kyungpook National University Hospital
Recruitment Status	Completed
Date of First Enrollment	2018-05-17 ,
Recruitment Status by Participating Study Site 2
Name of Study	Kyung Hee University Hospital at Gangdong
Recruitment Status	Completed
Date of First Enrollment	2018-08-08 ,
Recruitment Status by Participating Study Site 3
Name of Study	Kyung Hee University Hospital
Recruitment Status	Completed
Date of First Enrollment	2019-04-17 ,
Recruitment Status by Participating Study Site 4
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Completed
Date of First Enrollment	2018-12-24 ,
Recruitment Status by Participating Study Site 5
Name of Study	Inje University Busan Paik Hospital
Recruitment Status	Completed
Date of First Enrollment	2019-02-20 ,
Recruitment Status by Participating Study Site 6
Name of Study	Ulsan Univeristy Hospital
Recruitment Status	Completed
Date of First Enrollment	2018-11-20 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyungpook National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Kidney transplantation is the most effective treatment for patients with end-stage kidney disease, but rejection is the main cause of graft failure. There has been still no effective tools to diagnose rejection early and effectively. In this study, we assumed that monitoring of blood and urine biomarkers that predict acute rejection, which were identified through our previous studies, is beneficial for early diagnosis of rejection and preserve graft function. To confirm this, we enrolled the kidney transplant recipients with high immunologic risk and allocate into 1:1 ratio to experimental group and control group. All patients measured serum and urine biomarkers every four weeks and the measured biomarker values are notified only to the experimental group and are used as an additional indicator of rejection in addition to traditional markers. The primary outcome is glomerular filtration rate of 1 year after transplantation.

Study Summary Information

Lay Summary

Kidney transplantation is the most effective treatment for patients with end-stage kidney disease, but rejection is the main cause of graft failure. There has been still no effective tools to diagnose rejection early and effectively. In this study, we assumed that monitoring of blood and urine biomarkers that predict acute rejection, which were identified through our previous studies, is beneficial for early diagnosis of rejection and preserve graft function. To confirm this, we enrolled the kidney transplant recipients with high immunologic risk and allocate into 1:1 ratio to experimental group and control group. All patients measured serum and urine biomarkers every four weeks and the measured biomarker values are notified only to the experimental group and are used as an additional indicator of rejection in addition to traditional markers. The primary outcome is glomerular filtration rate of 1 year after transplantation.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Screening
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Others
Intervention Description	Both study groups check blood and urine biomarker levels at each visit. In the experimental group, biomarker changes and conventional markers are used together to predict the possibility of acute rejection. In the control group, traditional markers are used to predict acute rejection.
Number of Arms	2
Arm 1	Arm Label Biomarker group
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description Biomarkers for predicting acute rejection are measured in blood and urine samples at every four-week interval to predict the development of acute rejection.
Arm 2	Arm Label Control group
	Target Number of Participant 20
	Arm Type Active comparator
	Arm Description During every four-week visit, the rejection prediction biomarkers are measured in blood and urine samples, but the results are not notified to patient and clinicians, and the rejection is predicted only by traditional indicators.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N18.5)Chronic kidney disease, stage 5 Kidney Failure, Chronic
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~75Year
	Description 1) Newly kidney transplant recipient 2) Aged from 18 to 75 3) High risk of acute rejection (one or more of the following is satisfied) • HLA mismatch ≥5 • Pretransplant panel reactive antibody ≥30% • Pretransplant desensitization • Positive for direct cross match • Extended criteria deceased donor kidney transplantation 4) Induction immunosuppression using anti-thymocyte globulin or basiliximab,and maintenance immunosuppression by tacrolimus, mycophenolic acid and steroid
Exclusion Criteria	1) Active infection 2) HIV, HCV infection 3) Comorbid untreatable ischemic heart disease 4) Abnormality of hematologic exam (hemoglobin <7.0g/dL, leukocyte count <2,500/mm3, absolute neutrophil count <1,500/mm3, platelet count <75,000/mm3) 5) Pregnant 6) Multiorgan trasnplant 7) History of malignancy
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Glomerular filtration rate
Timepoint	1 year after kidney transplantation
Secondary Outcome(s) 1
Outcome	Occurrence of acute rejection
Timepoint	During 1 year after kidney transplantation
Secondary Outcome(s) 2
Outcome	Rate of graft failure
Timepoint	1 year after kidney transplantation
Secondary Outcome(s) 3
Outcome	Rate of kidney biopsy
Timepoint	1 year after kidney transplantation

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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