NCT01640119 - 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)

1
Eustace JA, et al. Prevalence of acidosis and inflammation and their association with low serum albumin in chronic kidney disease. Kidney Int. 2004 ;65:1031-40. 2.Ballmer PE, et al: Chronic metabolic acidosis decreases albumin synthesis and induces negative nitrogen balance in humans. J Clin Invest 1995;95:39-40 3.Chiu YW, et al: Correction of metabolic acidosis to ameliorate wasting in chronic kidney disease: goals and startegies. Sem Nephrol 2009;29:67-74 4.Bommer J, et al: association of predialysis serum bicarbonate levels with risk of mortality and hospitalization in the DOPPS. Am J Kidney Disease 2004;44:661-671 5.Wu DY, et al: Association between serum bicarbonate and death in hemodialysis patients: is it better to be acidosis or alkalotic? Clin J Am Soc Nephrol 2006;1:70-78 6.Kraut JA, Madias NE. Metabolic acidosis: pathophysiology, diagnosis and management. Nat Rev Nephrol. 2010;6:274-85. 7.Roderick P, et al. Correction of chronic metabolic acidosis for chronic kidney disease patients. Cochrane Database Syst Rev. 2007; Jan 24(1):CD001890. 8.de Brito-Ashurst I, et al: Bicarbonate supplementation slows progression of CKD and improves nutritional status. J Am Soc Nephrol 2009;20:2075-2084 9.Menon V, et al: Serum bicarbonate and long-term outcomes in CKD. Am J Kidney Disease 2010; 56:907-14 10.Wesson DE, Simoni J: Acid retention during kidney failure induces endothelin and aldosterone production which lead to progressive GFR decline, a situation ameliorated by alkali diet. Kidney Int 2010;78 1128-1135

A Prospective, Controlled, Randomized, Multicentric Study: Correction of Metabolic Acidosis With Use of Bicarbonate in Chronic Renal Insufficiency (CKD3b-4)

Details for clinical trial NCT01640119

Clinical trial NCT01640119 - References