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. 2016 Mar 24;6(1):28–41. doi: 10.5500/wjt.v6.i1.28

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.