Table 2.
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.