NCT01103076 - 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)

Meier P, Golshayan D, Blanc E, Pascual M, Burnier M
Oxidized LDL modulates apoptosis of regulatory T cells in patients with ESRD. J Am Soc Nephrol. 2009 Jun;20(6):1368-84. doi: 10.1681/ASN.2008070734. Epub 2009 Apr 30. Retraction in: J Am Soc Nephrol. 2014 Mar;25(3):645.
Meier P, Spertini F, Blanc E, Burnier M
Oxidized low-density lipoproteins activate CD4+ T cell apoptosis in patients with end-stage renal disease through Fas engagement. J Am Soc Nephrol. 2007 Jan;18(1):331-42. Epub 2006 Dec 20. Retraction in: J Am Soc Nephrol. 2014 Mar;25(3):645.

Effects of High Cut-off Hemodialysis on Central Memory CD4+ T Cells and Regulatory T Cells in Patients With End-stage Kidney Disease

Clinical trial NCT01103076 - References