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

2019-11-20 20:06:40 | BioPortfolio


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.


+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




dd-cfDNA Blood Test


University of Maryland
United States




University of Maryland, Baltimore

Results (where available)

View Results


Published on BioPortfolio: 2019-11-20T20:06:40-0500

Clinical Trials [5644 Associated Clinical Trials listed on BioPortfolio]

Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients

Detecting allograft injury and rejection is critical to preventing graft loss. The current standard of care (SoC) relies on serum creatinine (SC) and biopsy to monitor for and identify kid...

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

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 biomar...

Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant

This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a relative with the same (or nearly the same) blood cell type as the transplant...

NCAMR-CAMR Allosure Study

Heart Transplant recipients at Tampa General Hospital heart transplant program who have pAMR1(H+) or pAMR1(I+) rejection will have a DD-cfDNA /GEP sample obtained at the time of the reject...

Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling

Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in association with the measurement of AlloMap, a non-invasive gene expression test to aid in hea...

PubMed Articles [17913 Associated PubMed Articles listed on BioPortfolio]

Costs and factors associated with heart failure following kidney transplantation - a single center retrospective cohort study.

The number of adults with heart failure (HF) will increase by ~50% between 2012 and 2030. Among kidney transplant recipients, HF accounts for 16% of all post-transplant admissions. We describe the bur...

Cardiac Inotropes Offer Protection of Renal Function in Patients with Kidney Transplantation.

Impaired cardiac function is one of the most concomitant symptoms in patients with kidney failure after long-term dialysis. In addition, the preservation of adequate perfusion pressure to the graft pl...

Three-Month Pancreas Graft Function Significantly Influences Survival Following Simultaneous Pancreas-Kidney Transplantation in Type 2 Diabetes Patients.

Successful simultaneous pancreas-kidney transplantation (SPK) may improve patients' quality-of-life and prolong kidney allograft and overall survival in type-1 diabetic (T1DM) patients. However, the u...

Association of diagnosed obstructive sleep apnea with kidney transplant outcomes.

Obstructive sleep apnea (OSA) is common but underdiagnosed among patients with kidney disease. This study examines whether the diagnosis of OSA in kidney transplant recipients (KTR) affected death, de...

Difference in Survival in Early Kidney after Liver Transplant Compared with Simultaneous Liver-Kidney Transplantation: Evaluating the Potential of the "Safety Net".

Decisions on who requires simultaneous liver-kidney (SLK) transplantation are controversial. United Network for Organ Sharing implemented a "safety net" in 2017 providing prioritization on the kidney ...

Medical and Biotech [MESH] Definitions

A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.

A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.

The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.

A test to detect non-agglutinating ANTIBODIES against ERYTHROCYTES by use of anti-antibodies (the Coombs' reagent.) The direct test is applied to freshly drawn blood to detect antibody bound to circulating red cells. The indirect test is applied to serum to detect the presence of antibodies that can bind to red blood cells.

Acute kidney failure resulting from destruction of EPITHELIAL CELLS of the KIDNEY TUBULES. It is commonly attributed to exposure to toxic agents or renal ISCHEMIA following severe TRAUMA.

More From BioPortfolio on "Eliminating the Need for Pancreas Biopsy Using Peripheral Blood Cell-free DNA"

Quick Search

Relevant Topics

Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...

Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...

Searches Linking to this Trial