Clinical Trials Logo
  1. Home
  2. Transplant;Failure,Kidney
  3. NCT04166149

Eliminating the Need for Pancreas Biopsy Using Peripheral Blood Cell-free DNA — PancDX  

Transplant;Failure,Kidney Clinical Trial

Official title:
Non-invasive Blood Test to Diagnose Acute Rejection After Pancreas and Kidney Transplantation: Pancreas and Renal Rejection Diagnosis Using Circulating Donor-derived Cell-free DNA in Peripheral Blood

Clinical Trial Summary

Donor-derived cell-free DNA (dd-cfDNA) has shown promise as an early marker for cellular injury caused by rejection. dd-cfDNA changes may also indicate other injuries that lead to progressive decline in transplant organ function associated with, in the case of kidney transplantation, the presence of interstitial fibrosis (IF) and tubular atrophy (TA) seen in biopsy specimens. Here, we will study the utility of dd-cfDNA to predict rejection in pancreas and pancreas-kidney recipients.

Clinical Trial Description

+Objective The objective of this prospective observational study is to correlate circulating dd-cfDNA to clinical and sub-clinical acute rejection in pancreas transplant alone (PTA), pancreas after kidney (PAK), and simultaneous pancreas kidney (SPK) allograft recipients. The secondary objective study is to correlate circulating dd-cfDNA to pancreas and kidney function, using Hgb1c, C-peptide and insulin requirement to assess pancreas function, and using serum creatinine and estimated glomerular filtration rate (eGFR) to assess kidney function. The clinical data and specimen collection will also enable future biomarker research. +Study endpoints Serial dd-cfDNA in individuals over time will be correlated with clinical status and outcomes, such as events of allograft dysfunction or biopsy proven rejection. The primary endpoints of the study are: 1. Clinical T cell as well as antibody mediated acute rejection 2. Sub-clinical T cell as well as antibody mediated acute rejection 3. Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection. The secondary endpoints for the study are: 1. eGFR (estimated Glomerular Filtration Rate [mL/min]): will be derived from serum creatinine level, corrected for variables, using the CKD-RPI (Chronic Kidney Disease Epidemiology Collaboration) equation. 2. Renal allograft injury from BKV (Polyomaviridae polyomavirus) nephritis, CNI (calcineurin inhibitor) toxicity, acute pyelonephritis and recurrent disease confirmed by renal histology. 3. Pancreas allograft function derived from hemoglobin A1c, insulin requirement, and serum c-peptide per SOC 4. Pancreas allograft injury from pancreatitis (all causes, including gastrointestinal dysmotility or viral). 5. Correlate cfDNA levels with presence or absence of delayed graft function (DGF) and subsequent outcomes in a subset of enrolled patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04166149
Study type Observational
Source University of Maryland, Baltimore
Contact
Status Active, not recruiting
Phase
Start date September 1, 2019
Completion date October 31, 2024
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT05811468 - Study Correlation Between Blood, Tissue Gene Expression, Donor Derived Cell Free DNA and Histopathology in Kidney Transplant Recipients
Completed NCT03723668 - Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France
Recruiting NCT03737604 - TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant Phase 4
Completed NCT03765203 - Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients N/A
Completed NCT05809440 - Effectiveness of 20m-MB in KTR Symptom Control N/A
Enrolling by invitation NCT04491227 - Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection
Not yet recruiting NCT06396702 - EASE-SOT Pilot Study N/A
Recruiting NCT03310905 - Abdominal Wall Transplant N/A
Recruiting NCT05613010 - Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant N/A
Recruiting NCT06263257 - The Effect of Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients N/A
Completed NCT04715412 - Clinical Pharmacy Guided Patient Counselling and Adherence Support on Renal Transplant Recipients N/A
Active, not recruiting NCT05449496 - Dietary Intervention to Improve Kidney Transplant Outcomes N/A
Not yet recruiting NCT06089473 - Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates N/A
Withdrawn NCT04473924 - Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk Phase 2
Recruiting NCT04619732 - Real-time Monitoring of Kidney Grafts on Hypothermic Machine Perfusion N/A
Completed NCT03760263 - Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus Phase 4
Active, not recruiting NCT03380962 - Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant Phase 1/Phase 2
Active, not recruiting NCT03436368 - Continuous Spinal Anesthesia in Renal Transplantation N/A
Not yet recruiting NCT03322709 - Minimally Invasive Kidney Transplantation N/A
Recruiting NCT03778944 - Enhancing Renal Graft Function During Donor Anesthesia N/A