Quantitative evaluation of the diagnostic accuracy (AUC value, sensitivity, and specificity) of AXINON® renalTX-SCORE-U100®* for the detection of acute renal allograft rejections
Study Manager Clinical Development, numares AG
Kidney transplantation is the treatment method of choice for patients with terminal kidney failure . Transplant patients require frequent follow-up examinations to detect potential complications at an early stage. Therefore, biopsies are performed during aftercare. They are generally considered to be safe, but it remains an invasive procedure with a risk for complications, at worst of losing the transplant [2; 3]. A metabolite based, non-invasive test for the detection of acute rejection after transplantation would improve clinical detection of asymptomatic rejection to arrange a control biopsy or to supplement the physician’s assessment of patients with non-specific symptoms such as fever.
PARASOL is a multicenter prospective observational (non-interventional) study w/o follow-up
Urine samples from renal allograft patients ≥14 days after transplantation
Routine kidney biopsy
Metabolomics studies make it possible to analyze the entire metabolite spectrum (metabolome) to detect rising and falling concentrations of endogenous substances and associate them with pathological processes. Previous results from the UMBRELLA study, which was performed in collaboration with Bernhard Banas and co-workers from the Department of Nephrology at the University Hospital Regensburg, showed that it is possible to diagnose acute renal allograft rejection from urine using alanine, citrate, lactate, and urea normalized to urine creatinine. This metabolite constellation is further validated in the PARASOL study in a pan-European multicentre study. The diagnostic accuracy for the metabolite constellations will be determined based on their AUC value, sensitivity, and specificity depending on the cut-off value.
In 2017, numares launched the AXINON® renalTX-SCORE-U100®* for use in clinical routine.
1. Suthanthiran, M. and T.B. Strom, Renal transplantation. N Engl J Med, 1994. 331(6): p. 365-76.
2. Schwarz, A., et al., Safety and adequacy of renal transplant protocol biopsies. Am J Transplant, 2005. 5(8): p. 1992-6.
3. Furness, P.N., et al., Protocol biopsy of the stable renal transplant: a multicenter study of methods and complication rates. Transplantation, 2003. 76(6): p. 969-73.
*numares’ products are not yet available for sale within the United States; they have not yet been approved or cleared by the U.S. Food and Drug Administration.
5th - 10th November, 2019
Washington, DC, USA
There will be a poster presentation showing latest results about metabolomics based detection of kidney allograft rejection by evaluating a metaboliteconstellation of biomarkers to support non-invasive, thus close monitoring after kidney transplant.
November 1 - 6, 2022
Orlando, FL, USA
April 6 - 10, 2022
Boston, MA, USA
Banas, M., et al.
A Prospective Multicenter Trial to Evaluate Urinary Metabolomics for Non-invasive Detection of Renal Allograft Rejection (PARASOL): Study Protocol and Patient Recruitment.
Front. Med. (2022)
Ehrich, J., et al.
Serum myo-inositol, dimethyl sulfone, and valine in combination with creatinine allow accurate assessment of renal insufficiency.
Stämmler, F., et al.
Estimating Glomerular Filtration Rate from Serum Myo-Inositol, Valine, Creatinine and Cystatin C.
Atul K. Sharma Tom D. Blydt-Hansen
To accompany Banas et al., Time for a Paradigm Shift
M. Banas, S. Neuman, P. Pagel, F. J. Putz, G. Boehmig, J. Eiglsperger, et al.
A urinary metabolite constellation to detect acute rejection in kidney allografts
M. Banas, S. Neumann, J. Eiglsperger, E. Schiffer, F. J. Putz, S. Reichelt-Wurm, et al.
Identification of a urine metabolite constellation characteristic for kidney allograft rejection
Metabolomics Off J Metabolomic Soc, 14 (9) (2018), p. 116
Development and validation of an NMR based metabolite constellation determining glomerular filtration rate for a more accurate picture of the underlying kidney function.
“The numares‘ metabolomics approach bears the innovative und non-invasive potential to determine severity and complexity of CKD without using eGFR equations based on creatinine and cystatin C. Furthermore, the metabolite panel offers chances for studying CKD induced co-morbidities.“,
Professor Emeritus Jochen Ehrich, MD, DCMT (London), Honorary Member of the European Society for Paediatric Nephrology
According to the KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease, the severity of CKD should be classified based on glomerular filtration rate (GFR), etiology and albuminuria. The gold standards to determine measured GFR are inulin and other exogenous substances [1, 2, 3]. These mGFR methods are expensive, invasive, time-consuming and very limited for routine use in out-patient settings. Therefore, GFR is mostly estimated by...
Development and Evaluation of a metabolite constellation for the diagnosis of bladder cancer in patients with persistent microhaematuria.
“A minimal invasive diagnostic test for a reliable detection of bladder cancer.“
Amauri G.S. Santamaría, Study Manager Clinical Development, numares AG
Urinary bladder cancer (BCa) is a malignant tumour that usually develops in the mucous membrane (urothelial carcinoma) of the bladder. The symptoms are relatively unspecific. One of the earliest cardinal symptoms of BCa is microscopically detectable haematuria, so-called microhaematuria, . However, microhaematuria commonly has benign causes, such as infection, benign prostate enlargement...
Development and validation of a metabolite constellation in serum for early detection of hepatocellular cancer.
“A diagnostic screening test for early detection of hepatocellular cancer to supplement abdominal sonography in HCC surveillance.“
Hepatocellular carcinoma (HCC) is an aggressive tumor of the liver with annual incidence of 1-6% in at risk patients with liver cirrhosis [1, 2]). Most patients have symptoms only in advanced stage HCC, impeding early detection of the tumor. The 5-year survival rate is <10% if HCC is diagnosed after symptoms...
Development and Validation of an NMR-based metabolite constellation that early indicates the transition of relapsing-remitting (RRMS) to secondary progressive multiple sclerosis (SPMS).
“A serum-based test for early diagnosis of the RRMS-to-SPMS transition to allow timely therapy adjustment”
Dr. Eric Schiffer, Head of Clinical Development, numares AG
Multiple sclerosis (MS) is considered to be an immune-mediated disease in which the body’s own defence cells attack the central nervous system. MS involves inflammatory and neurodegenerative processes that damage the insulating myelin sheaths of nerve fibers and the nerve cells themselves. While about 10-15% of patients begin the disease with primary progressive MS (PPMS) showing continuously worsening of symptoms from disease onset, the majority of patients are initially diagnosed...