NCT05793346 - 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)

Piccoli GB, Zakharova E, Attini R, Ibarra Hernandez M, Orozco Guillien A, Alrukhaimi M, Liu ZH, Ashuntantang G, Covella B, Cabiddu G, Li PKT, Garcia-Garcia G, Levin A
Pregnancy in Chronic Kidney Disease: Need for Higher Awareness. A Pragmatic Review Focused on What Could Be Improved in the Different CKD Stages and Phases. J Clin Med. 2018 Nov 5;7(11):415. doi: 10.3390/jcm7110415.
Tong A, Jesudason S, Craig JC, Winkelmayer WC
Perspectives on pregnancy in women with chronic kidney disease: systematic review of qualitative studies. Nephrol Dial Transplant. 2015 Apr;30(4):652-61. doi: 10.1093/ndt/gfu378. Epub 2014 Dec 18.
Wiles K, Webster P, Seed PT, Bennett-Richards K, Bramham K, Brunskill N, Carr S, Hall M, Khan R, Nelson-Piercy C, Webster LM, Chappell LC, Lightstone L
The impact of chronic kidney disease Stages 3-5 on pregnancy outcomes. Nephrol Dial Transplant. 2021 Nov 9;36(11):2008-2017. doi: 10.1093/ndt/gfaa247.

Pregnancy-associated Progression of Chronic Kidney Disease: A Study Protocol for the Development and Validation of a Clinical Predictive Tool

Clinical trial NCT05793346 - References