NCT03870542 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Gámez-Valero A, Lozano-Ramos SI, Bancu I, Lauzurica-Valdemoros R, Borràs FE
Urinary extracellular vesicles as source of biomarkers in kidney diseases. Front Immunol. 2015 Jan 30;6:6. doi: 10.3389/fimmu.2015.00006. eCollection 2015. Review.
Gonzalez-Nolasco B, Wang M, Prunevieille A, Benichou G
Emerging role of exosomes in allorecognition and allograft rejection. Curr Opin Organ Transplant. 2018 Feb;23(1):22-27. doi: 10.1097/MOT.0000000000000489. Review.
Hanssen O, Erpicum P, Lovinfosse P, Meunier P, Weekers L, Tshibanda L, Krzesinski JM, Hustinx R, Jouret F
Non-invasive approaches in the diagnosis of acute rejection in kidney transplant recipients. Part I. In vivo imaging methods. Clin Kidney J. 2017 Feb;10(1):97-105. doi: 10.1093/ckj/sfw062. Epub 2016 Jul 28. Review.
Li B, Hartono C, Ding R, Sharma VK, Ramaswamy R, Qian B, Serur D, Mouradian J, Schwartz JE, Suthanthiran M
Noninvasive diagnosis of renal-allograft rejection by measurement of messenger RNA for perforin and granzyme B in urine. N Engl J Med. 2001 Mar 29;344(13):947-54.
Singh T, Astor B, Zhong W, Mandelbrot D, Djamali A, Panzer S
Kidney Transplant Recipients With Primary Membranous Glomerulonephritis Have a Higher Risk of Acute Rejection Compared With Other Primary Glomerulonephritides. Transplant Direct. 2017 Oct 18;3(11):e223. doi: 10.1097/TXD.0000000000000736. eCollection 2017 Nov.

Multicenter, Prospective Observational Study to Identify and Validate a Composite of Urinary Exosomal Biomarkers for Kidney Allograft Tubulointerstitial Fibrosis

Details for clinical trial NCT03870542

Clinical trial NCT03870542 - References