Kidney Transplant Failure and Rejection Clinical Trial
Official title:
Research on the Detection of Donor Derived Cell Free DNA (cfDNA)for the Early-stage Diagnosis of Acute Rejection Reaction Post Kidney Transplantation
Acute rejection (AR) is still one of the major complications after kidney transplantation. The current diagnosis measure for AR is primarily pathological puncture test and hematuria biomarker detection, yet due to their inferior performance on timeliness, the allograft kidneys usually have been in severe conditions when the diagnoses take place. Donor derived cell free DNA (dd-cfDNA) is utilized as a measure for "liquid biopsy", it can predict acute rejection at very early periods, and it is easy to operate, with fewer invasive injuries, and can reflect related conditions in a timely manner, etc.. This study plans to utilize second-generation sequencing technology to systematically evaluate the abundance variations of nuclear genome and mitocondria derived dd-cfDNA in the kidney transplant recipients' blood and urine, thus it can assist in accumulating more proof for the clinical utilization of dd-cfDNA from different sources at the early stages of AR in evidence-based medicine, and lay foundation for the development of dd-cfDNA based early-stage rejection detection tools afterkidney transplantation surgery.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | September 30, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patients are suitable for kidney transplant surgeries. Or There is obvious evidence for acute rejection of the allograft kidneys. The patients have no infectious complications. Exclusion Criteria: - Patients have failed in the transplant surgeries. Patients have no urine 1 week after the transplant surgeries. Patients have severe infectious complications after the transplant surgeries. Or:The patients have infectious complications. The patients have tumors. The patients are pregnant. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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RenJi Hospital |
De Vlaminck I, Martin L, Kertesz M, Patel K, Kowarsky M, Strehl C, Cohen G, Luikart H, Neff NF, Okamoto J, Nicolls MR, Cornfield D, Weill D, Valantine H, Khush KK, Quake SR. Noninvasive monitoring of infection and rejection after lung transplantation. Pro — View Citation
Lo YM, Tein MS, Pang CC, Yeung CK, Tong KL, Hjelm NM. Presence of donor-specific DNA in plasma of kidney and liver-transplant recipients. Lancet. 1998 May 2;351(9112):1329-30. — View Citation
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---|---|---|---|---|
Primary | Renal allograft injury Renal allograft injury | serum creatinine level | 2 months |
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