Proteomics for rejection diagnosis in renal transplant patients: Where are we now?

Table 2 Ongoing proteomic studies on rejection in renal transplant patients

Study identifier and title	Aim	Institution/PI	Single/multi-centre	Patients	Study start	Estimated primary completion	Status of the study
NCT01515605	Analysis of GATA3, GATA4, GAPDH, TRPC3, TRPC6, granzyme B, perforin, FOXP3, ISG15, Mx1, MMP-3, MMP-9 in blood cells, proteomic analysis of urine, tissue analysis in a longitudinal fashion. Correlation of these parameters to the outcome	Odense University Hospital, Denmark	NR	1000	January 2011	March 2014	Unknown
Molecular biological and molecular genetic monitoring of therapy after kidney transplantation
NCT01315067	Phase III in-place validation of a pre-defined, published urinary peptide panel for acute TCMR against the current standard allograft biopsy[43]	Hannover Medical School, Germany	Multi	600	October 2011	December 2015	Active, not recruiting
Non-invasive diagnosis of acute rejection in renal transplant patients using mass spectrometry of urine samples - a multicentre diagnostic phase III trial[62]
NCT01531257	Validation of a set of candidate molecules by urine proteomics, gene expression analysis of blood cells and graft biopsies in a longitudinal fashion with respect to AR and IFTA	Northwestern University, Chicago, Illinois, United States	Single	250	April 2010	April 2016	Recruiting
Proteogenomic monitoring and assessment of kidney transplant recipients
NCT01289717	Discovery and validation of candidate molecules by urine proteomics, gene expression analysis of blood cells and allograft biopsies in a longitudinal fashion with respect to AR and IFTA	National Institute of Allergy and Infectious Diseases; Northwestern University, Chicago, Illinois, United States	Multi	307	March 2011	June 2016	Active, not recruiting
Discovery and validation of proteogenomic biomarker panels in a prospective serial blood and urine monitoring study of kidney transplant recipients - transplant proteogenomics
NCT02463253	Analysis of proteogenomic and proteomic biomarkers in relation to the biopsy diagnosis of acute rejection in a longitudinal fashion	University of California, Sacramento, California, United States	Single	50	April 2015	December 2016	Recruiting
Correlation of molecular biomarkers with biopsy findings and outcomes in renal transplant recipients

All studies are prospective, observational cohort studies in adult patients. Preliminary reports have not been published yet. Except study NCT 01315067, all studies collect samples in a longitudinal fashion and examine additional markers obtained by genomic analysis of blood cells. PI: Principal investigator site; AR: Acute rejection; IFTA: Interstitial fibrosis and tubular atrophy; NR: Not reported.