Prospective safety study of bardoxolone methyl in patients with type 2 diabetes mellitus, end-stage renal disease and peritoneal dialysis.
Patients on peritoneal dialysis experience inflammation associated with advanced chronic kidney disease and the therapy itself. An important consequence of the inflammation may be acceleration of the rate of decline in residual renal function. The decline in residual renal function has been associated with an increased mortality for patients in this population. Bardoxolone methyl is a synthetic triterpenoid. To date, the effects of bardoxolone methyl on kidney function in humans have been studied in patients with type 2 diabetes mellitus. A large-scale event-driven study of bardoxolone methyl in patients with type 2 diabetes mellitus with stage 4 chronic kidney disease is underway. The safety of bardoxolone methyl has not been evaluated in patients with more advanced (stage 5) chronic kidney disease or patients on dialysis. This report describes a proposed double blind, prospective evaluation of bardoxolone methyl in patients with type 2 diabetes mellitus receiving peritoneal dialysis. In addition to assessing the safety of bardoxolone methyl in this population, the study will evaluate the effect of bardoxolone methyl on residual renal function over 6 months as compared to placebo.
David G
DG
Warnock
Sudarshan
S
Hebbar
Joanne
J
Bargman
John
J
Burkart
Simon
S
Davies
Frederic O
FO
Finkelstein
Rajnish
R
Mehrotra
Claudio
C
Ronco
Isaac
I
Teitelbaum
Kingsley
K
Urakpo
Glenn M
GM
Chertow
D002986:Clinical Trials as Topic; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004311:Double-Blind Method; D006801:Humans; D007249:Inflammation / Q000209:etiology; D007676:Kidney Failure, Chronic / Q000209:etiology / Q000628:therapy*; D009828:Oleanolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives*; D010530:Peritoneal Dialysis / Q000009:adverse effects*; D011446:Prospective Studies; D012107:Research Design; D018401:Sample Size
D009828:Oleanolic Acid; C445068:bardoxolone methyl