NCT04286477 - 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)

Caprara C, Kinsey GR, Corradi V, Xin W, Ma JZ, Scalzotto E, Martino FK, Okusa MD, Nalesso F, Ferrari F, Rosner M, Ronco C
The Influence of Hemodialysis on T Regulatory Cells: A Meta-Analysis and Systematic Review. Blood Purif. 2016;42(4):307-313. Epub 2016 Oct 1.
Heine GH, Ulrich C, Seibert E, Seiler S, Marell J, Reichart B, Krause M, Schlitt A, Köhler H, Girndt M
CD14(++)CD16+ monocytes but not total monocyte numbers predict cardiovascular events in dialysis patients. Kidney Int. 2008 Mar;73(5):622-9. Epub 2007 Dec 26.
Kim HW, Yang HN, Kim MG, Choi HM, Jo SK, Cho WY, Kim HK
Microinflammation in hemodialysis patients is associated with increased CD14CD16(+) pro-inflammatory monocytes: possible modification by on-line hemodiafiltration. Blood Purif. 2011;31(4):281-8. doi: 10.1159/000321889. Epub 2011 Jan 14.
Vacher-Coponat H, Brunet C, Lyonnet L, Bonnet E, Loundou A, Sampol J, Moal V, Dussol B, Brunet P, Berland Y, Dignat-George F, Paul P
Natural killer cell alterations correlate with loss of renal function and dialysis duration in uraemic patients. Nephrol Dial Transplant. 2008 Apr;23(4):1406-14. Epub 2007 Nov 20.
Wolley M, Jardine M, Hutchison CA
Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules. Clin J Am Soc Nephrol. 2018 May 7;13(5):805-814. doi: 10.2215/CJN.10110917. Epub 2018 Mar 5. Review.

The Immune System in End Stage Chronic Kidney Disease (CKD) Patients - Comparison Among Different Modalities of Renal Replacement Therapy (RRT)

Clinical trial NCT04286477 - References