NCT05801549 - 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)

Colley, E
, Carroll, J., Anne, S., Shannon, T., Ramon, V. and Tracie, B. (2022). A longitudinal study of the arterio-venous fistula maturation of a single patient over 15 weeks. Biomechanics and Modeling in Mechanobiology, pp.1-16. Dixon, B.S. (2006). Why don't fistulas mature? Kidney International, 70 (8): pp1413-1422. Liyanage, T., Ninomiya, T., Jha, V., Neal, B., Patrice, H.M., Okpechi, I., Zhao, M.H., Lv, J., Garg, A.X., Knight, J. and Rodgers, A. (2015). Worldwide access to treatment for end-stage kidney disease: a systematic review. The Lancet, 385 (9981), pp.1975-1982.

Arterio-Venous Fistula Audit. Successful Utilisation Rates of Arterio-Venous Fistulae for Haemodialysis at University Hospital Limerick

Clinical trial NCT05801549 - References