NCT05226936

Brief Summary

The aim of this study is to evaluate highly sensitive quantitative tests for early molecular detection of graft rejection and associated immune response from liquid biopsies in the blood from patients undergoing renal transplantation and secondly, to evaluate the evolution of de-novo HLA antibodies following renal transplantation. Furthermore, we are interested in the correlation of tissue damage caused by rejection, as measured by the presence of dd-cfDNA, and the presence of de-novo HLA antibodies.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 27, 2022

Last Update Submit

January 27, 2022

Conditions

Cell-Free Nucleic Acids

Outcome Measures

Primary Outcomes (1)

  • Degree of chimerism

    The fraction of cell free donor DNA will be measured after transplant

    According to the study protocol before and after transplantation in defined intervals up to 3 moths

Interventions

Cell free DNA analysisDIAGNOSTIC_TEST

samples will be analysed using molecular techniques including sequencing for measuring dd-cfDNA or analysis of the presence of HLA-antibodies using commercial bead-technologies (Luminex or Immucor)

Also known as: Donor Specific Antibody analysis

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing live donor or deceased donor transplantation

You may qualify if:

  • Patients older than 20 undergoing kidney transplantation -

You may not qualify if:

  • Patients included in other studies Patients a combined transplant with other donor Patients not eligible to sign an inform consent Patients with primary non-function or those that lost their graft during the first 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Bloom RD, Bromberg JS, Poggio ED, Bunnapradist S, Langone AJ, Sood P, Matas AJ, Mehta S, Mannon RB, Sharfuddin A, Fischbach B, Narayanan M, Jordan SC, Cohen D, Weir MR, Hiller D, Prasad P, Woodward RN, Grskovic M, Sninsky JJ, Yee JP, Brennan DC; Circulating Donor-Derived Cell-Free DNA in Blood for Diagnosing Active Rejection in Kidney Transplant Recipients (DART) Study Investigators. Cell-Free DNA and Active Rejection in Kidney Allografts. J Am Soc Nephrol. 2017 Jul;28(7):2221-2232. doi: 10.1681/ASN.2016091034. Epub 2017 Mar 9.

    PMID: 28280140BACKGROUND

  • Everly MJ, Terasaki PI. Monitoring and treating posttransplant human leukocyte antigen antibodies. Hum Immunol. 2009 Aug;70(8):655-9. doi: 10.1016/j.humimm.2009.04.019. Epub 2009 Apr 15.

    PMID: 19375466BACKGROUND

  • Lee PC, Zhu L, Terasaki PI, Everly MJ. HLA-specific antibodies developed in the first year posttransplant are predictive of chronic rejection and renal graft loss. Transplantation. 2009 Aug 27;88(4):568-74. doi: 10.1097/TP.0b013e3181b11b72.

    PMID: 19696641BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood serum and urine samples

Central Study Contacts

Eytan Mor, MD

CONTACT

052-2297779eytan.mor@sheba.health.gov.il

Maya Mor-Cohen

CONTACT

052-5361988Maya.MorCohen@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Kidney Transplant Center

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 7, 2022

Study Start

April 1, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

February 7, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

The study is in collaboration with the transplant center in Sweden. Each study patients will be given a code and the coded information will be shared with our partners

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
The data will be available for 3 yeras from the completion of the recuitment of all patients
Access Criteria
Shared mail with an access code