NCT00397358 - 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)

Amici G, Orrasch M, Da Rin G, Bocci C
Hyperinsulinism reduction associated with icodextrin treatment in continuous ambulatory peritoneal dialysis patients. Adv Perit Dial. 2001;17:80-3.
Bredie SJ, Bosch FH, Demacker PN, Stalenhoef AF, van Leusen R
Effects of peritoneal dialysis with an overnight icodextrin dwell on parameters of glucose and lipid metabolism. Perit Dial Int. 2001 May-Jun;21(3):275-81.
Furuya R, Odamaki M, Kumagai H, Hishida A
Beneficial effects of icodextrin on plasma level of adipocytokines in peritoneal dialysis patients. Nephrol Dial Transplant. 2006 Feb;21(2):494-8. Epub 2005 Oct 12.
Holmes CJ, Shockley TR
Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41. Review.
Kronenberg F, Lingenhel A, Neyer U, Lhotta K, König P, Auinger M, Wiesholzer M, Andersson H, Dieplinger H
Prevalence of dyslipidemic risk factors in hemodialysis and CAPD patients. Kidney Int Suppl. 2003 May;(84):S113-6.
Martikainen T, Teppo AM, Gronhagen-Riska C, Ekstrand A
Benefit of glucose-free dialysis solutions on glucose and lipid metabolism in peritoneal dialysis patients. Blood Purif. 2005;23(4):303-10. Epub 2005 Jun 23.

Open-label Study to Evaluate the Effects of Once Daily Extraneal (7.5% Icodextrin) Peritoneal Dialysis Solution on Triglyceride Levels in Peritoneal Dialysis Patients

Details for clinical trial NCT00397358

Clinical trial NCT00397358 - References