Study in Detection cfDNA for the Early-stage Diagnosis of Acute Rejection Post-renal Transplantation

NCT03759535 | Unknown DMC

• 1 other identifier: RenJiH-renal transplantation01
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Kidney Transplant Failure and Rejection

Keywords

DNA acute rejection kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Renal allograft injury Renal allograft injury

  serum creatinine level

  2 months

Study Arms (1)

Control group and Case group

Control group: The allograft kidneys function normally. The rejection of allograft kidneys are excluded. The patients have no infectious complications. Case group: There is obvious evidence for acute rejection of the allograft kidneys. The patients have no infectious complications.

Diagnostic Test: Acute rejection

Interventions

Acute rejection DIAGNOSTIC_TEST

Donor derived cell free DNA

Control group and Case group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

20 to-receive-kidney-transplant patients are randomized, the self-control study protocol is utilized for each patient as the following. Under the condition of signed informed consent, for 20 kidney transplant recipients For 20 patients that have been diagnosed with acute rejection on the first visits.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Related Publications (2)

• 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. Proc Natl Acad Sci U S A. 2015 Oct 27;112(43):13336-41. doi: 10.1073/pnas.1517494112. Epub 2015 Oct 12.

  PMID: 26460048 RESULT

• 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. doi: 10.1016/s0140-6736(05)79055-3. No abstract available.

  PMID: 9643800 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Donor derived cell free DNA (dd-cfDNA) is utilized as a measure for "liquid biopsy", it is easy to operate, with less invasiveness, and it can reflect related conditions in a timely manner，etc.. This measure can detect the injury degree for allograft, and the index will rise before fluctuation reflection of the syndrome and related laboratory indexes, which is crucial for the very early-stage diagnosis of allograft acute rejection, and the further prevention of allograft injury. In the mean time, dd-cfDNA assumes high utilization value for the monitoring of immunosuppressive conditions, and therefore providing instructions for the optimization of the immunosuppressive treatment.

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Zhang Ming, Doctor

  RenJi Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhang Ming, Doctor

CONTACT

13817817827; drmingzhang@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 30, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: September 30, 2021
• Last Updated: November 30, 2018

Record last verified: 2018-09