NCT05811468

Brief Summary

This study will compare the performance of Gene Expression Profile (GEP)/ Donor derived cell free deoxyribonucleic acid (dd-cfDNA) tests, to the following tests: Molecular Microscope (MMDx) and histopathology (study of changes in tissues caused by disease) in their ability to diagnose (exactly identify) various types of injury within the transplanted kidney.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 17, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 26, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

March 17, 2023

Last Update Submit

April 17, 2024

Conditions

Transplant;Failure,KidneyKidney TransplantKidney Rejection Transplant

Keywords

Gene expression profileMolecular microscopeDonor derived cell free DNAKidney biopsy

Outcome Measures

Primary Outcomes (2)

  • Quantify the number of rejections in the kidney allograft detected via non invasive blood- based testing as reflected in abnormal laboratory readout of GEP value and dd-CFDNA fraction.

    The number of rejections in the kidney allograft detected via blood- based non invasive testing will be measured and compared to the number of rejection cases detected by histopathology and MMDX to ascertain accuracy of blood based assays to detect rejection among kidney transplant recipients

    Through study completion, an average of 1 year

  • Quantify the number of rejection cases detected by histopathology and MMDX as reported by respective pathology laboratories/ pathologists

    Measure the number of rejections in the kidney allograft detected by histopathology and MMDX as invasive tests and ascertain concordance of those results with blood based non invasive assays.

    Through study completion, an average of 1 year

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing a for cause biopsy due to ongoing or suspected "injury" of the kidney allograft.

You may qualify if:

  • Patients undergoing a for cause biopsy due to ongoing or suspected "injury" of the allograft.
  • Patients will be between 3 months and 7 years post-transplant episode.
  • Recipients of both cadaveric and living donor renal transplant are considered eligible.

You may not qualify if:

  • No multi organ transplant recipients will be included.
  • Pregnancy
  • HIV positive recipients
  • Recipients of kidney transplant from an identical sibling
  • Patients with active and biopsy proven BK nephropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

  • Gupta G, Moinuddin I, Kamal L, King AL, Winstead R, Demehin M, Kang L, Kimball P, Levy M, Bhati C, Massey HD, Kumar D, Halloran PF. Correlation of Donor-derived Cell-free DNA With Histology and Molecular Diagnoses of Kidney Transplant Biopsies. Transplantation. 2022 May 1;106(5):1061-1070. doi: 10.1097/TP.0000000000003838. Epub 2021 May 28.

    PMID: 34075006BACKGROUND

  • Park S, Guo K, Heilman RL, Poggio ED, Taber DJ, Marsh CL, Kurian SM, Kleiboeker S, Weems J, Holman J, Zhao L, Sinha R, Brietigam S, Rebello C, Abecassis MM, Friedewald JJ. Combining Blood Gene Expression and Cellfree DNA to Diagnose Subclinical Rejection in Kidney Transplant Recipients. Clin J Am Soc Nephrol. 2021 Oct;16(10):1539-1551. doi: 10.2215/CJN.05530421.

    PMID: 34620649BACKGROUND

  • 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

  • Sigdel TK, Archila FA, Constantin T, Prins SA, Liberto J, Damm I, Towfighi P, Navarro S, Kirkizlar E, Demko ZP, Ryan A, Sigurjonsson S, Sarwal RD, Hseish SC, Chan-On C, Zimmermann B, Billings PR, Moshkevich S, Sarwal MM. Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR. J Clin Med. 2018 Dec 23;8(1):19. doi: 10.3390/jcm8010019.

    PMID: 30583588BACKGROUND
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 13, 2023

Study Start

September 26, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2025

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations

US(1)