NCT03405233 - 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)

Cheng C, Tempel D, van Haperen R, van der Baan A, Grosveld F, Daemen MJ, Krams R, de Crom R
Atherosclerotic lesion size and vulnerability are determined by patterns of fluid shear stress. Circulation. 2006 Jun 13;113(23):2744-53. Epub 2006 Jun 5.
Ghonemy TA, Farag SE, Soliman SA, El-okely A, El-hendy Y
Epidemiology and risk factors of chronic kidney disease in the El-Sharkia Governorate, Egypt. Saudi J Kidney Dis Transpl. 2016 Jan;27(1):111-7. doi: 10.4103/1319-2442.174137.
Ong S, Barker-Finkel J, Allon M
Long-term outcomes of arteriovenous thigh grafts in hemodialysis patients: a comparison with tunneled dialysis catheters. Clin J Am Soc Nephrol. 2013 May;8(5):804-9. doi: 10.2215/CJN.09240912. Epub 2013 Jan 31.
Tsoulfas G, Hertl M, Ko DS, Elias N, Delmonico FL, Romano L, Fernandes I, Schoenfeld D, Kawai T
Long-term outcome of a cuffed expanded PTFE graft for hemodialysis vascular access. World J Surg. 2008 Aug;32(8):1827-31. doi: 10.1007/s00268-008-9514-z.

Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients: a Randomized Controlled Trial

Clinical trial NCT03405233 - References