Evaluation of effectiveness of biomarkers for early diagnosis of acute rejection in renal transplant recipients

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005991

Enrollment

Registered

2021-03-11

Start date

2018-05-17

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : 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 a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

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

Design outcomes

Primary

Measure	Time frame
Glomerular filtration rate	—

Secondary

Measure	Time frame
Occurrence of acute rejection;Rate of graft failure;Rate of kidney biopsy	—

Countries

Korea, Republic of

Contacts

Public ContactJeong-Hoon Lim

Kyungpook National University Hospital

hunph84@naver.com+82-53-200-5550

Outcome results