drugset / Trial / NCT02273570
Optimal Anemia Treatment in End Stage Renal Disease (ERSD)
RandomizedParallel-groupOpen-labelSupportive care
Summary
Clinical study aimed at improving anemia management in End Stage Renal Disease Patient (ESRD) on maintenance Hemodialysis with evidence of Chronic Kidney disease Mineral Bone Disorder (CKD-MBD)
Timeline
- Start
- 2015-03
- Primary completion
- 2016-12
- Completion
- 2017-03
Publications
- Background Capuano A, Serio V, Pota A, Memoli B, Andreucci VE. Beneficial effects of better control of secondary hyperparathyroidism with paricalcitol in chronic dialysis patients. J Nephrol. 2009 Jan-Feb;22(1):59-68.
- Background Ebben JP, Gilbertson DT, Foley RN, Collins AJ. Hemoglobin level variability: associations with comorbidity, intercurrent events, and hospitalizations. Clin J Am Soc Nephrol. 2006 Nov;1(6):1205-10. doi: 10.2215/CJN.01110306. Epub 2006 Sep 6.
- Background Fishbane S, Berns JS. Hemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin. Kidney Int. 2005 Sep;68(3):1337-43. doi: 10.1111/j.1523-1755.2005.00532.x.
- Background Gilbertson DT, Ebben JP, Foley RN, Weinhandl ED, Bradbury BD, Collins AJ. Hemoglobin level variability: associations with mortality. Clin J Am Soc Nephrol. 2008 Jan;3(1):133-8. doi: 10.2215/CJN.01610407. Epub 2007 Nov 28.
- Background Lacson E Jr, Ofsthun N, Lazarus JM. Effect of variability in anemia management on hemoglobin outcomes in ESRD. Am J Kidney Dis. 2003 Jan;41(1):111-24. doi: 10.1053/ajkd.2003.50030.
- Background Pisoni RL, Bragg-Gresham JL, Young EW, Akizawa T, Asano Y, Locatelli F, Bommer J, Cruz JM, Kerr PG, Mendelssohn DC, Held PJ, Port FK. Anemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2004 Jul;44(1):94-111. doi: 10.1053/j.ajkd.2004.03.023.
- Background Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2009 Aug;(113):S1-130. doi: 10.1038/ki.2009.188.
- Background National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003 Oct;42(4 Suppl 3):S1-201. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Aluminum Phosphate | Unknown | — | — |
| Background | Calcitriol | Small molecule | — | — |
| Background | Calcium carbonate | Other / unclassified | — | — |
| Background | Cinacalcet | Other / unclassified | 90 mg | — |
| Background | Lanthanum Carbonate | Other / unclassified | — | — |
| Background | Magnesium carbonate | Small molecule | — | — |
| Background | Paricalcitol | Other / unclassified | 6 ug | — |
| Background | Sevelamer | Other / unclassified | — | — |
| Background | vitamin-25-OH-D | Unknown | 400 iu | — |