Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05811468
Other study ID # 22060707
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 26, 2023
Est. completion date May 30, 2025

Study information

Verified date April 2024
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This study will evaluate the performance of the blood-based assays like gene expression panel (GEP), and donor derived cell free DNA (dd-cfDNA) against tissue-based assays like molecular microscope (MMDX) and histopathology in their ability to more accurately detect presence of rejection among kidney transplant recipients deemed at higher than usual risk for immunologic injury i.e., rejection. Furthermore, the study should shed light on the ability of the different blood- based assays to accurately discern between the different types of rejection (early cellular versus humoral) against such confirmed by histopathology and molecular microscope. The study will also shed light on the ability of these noninvasive biomarkers to be utilized as a tool of immunomodulation in addition to studying their ability to accurately confirm presence of adequately treated rejection among the recipients of kidney transplant.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 30, 2025
Est. primary completion date May 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04087720 - Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant Phase 4
Completed NCT03749356 - Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients Phase 4
Completed NCT03527238 - Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine Phase 2
Completed NCT00498576 - Melatonin and Adiponectin in Hypertensive Kidney Transplant N/A
Completed NCT00642655 - Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation Phase 1/Phase 2
Completed NCT00374400 - The Paired Donation Consortium Paired Donation Program N/A
Completed NCT01710033 - A Study Of CP-690,550 In Stable Kidney Transplant Patients Phase 1
Completed NCT00205257 - Prediction of Acute Rejection in Renal Transplant Phase 1
Completed NCT02711826 - Treg Therapy in Subclinical Inflammation in Kidney Transplantation Phase 1/Phase 2
Withdrawn NCT03978494 - Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients. Phase 1
Completed NCT03837522 - Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies N/A
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT05029310 - Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients Phase 4
Completed NCT03644485 - Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients Phase 4
Active, not recruiting NCT02409901 - Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients N/A
Completed NCT01047410 - ACtive Care After Transplantation, the ACT Study N/A
Completed NCT00940940 - Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation Phase 4
Completed NCT00270712 - A Study of Factors That Affect Long-Term Kidney Transplant Function
Completed NCT00217126 - The Study of Long-term Deterioration of Kidney Transplants. Phase 4
Completed NCT00171496 - Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients Phase 4