Rationale--Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): evolving the management of cardiovascular risk in patients with chronic kidney disease.
BACKGROUND
Patients with chronic kidney disease (CKD) have a high burden of mortality and cardiovascular morbidity. Additional strategies to modulate cardiovascular risk in this population are needed. Data suggest that anemia is a potent and potentially modifiable risk factor for cardiovascular disease in patients with CKD, but these data remain unsubstantiated by any randomized controlled trial (RCT). Furthermore, the clinical practice guidelines for anemia management in patients with CKD are based on limited data. The need for new RCTs to address critical knowledge deficits, particularly with regard to the impact of anemia therapy on cardiovascular disease and survival, is recognized within the guidelines and independent comprehensive reviews of the existing published trial data.


METHODS
The Trial to Reduce Cardiovascular Events with Aranesp (Amgen Inc, Thousand Oaks, Calif) (darbepoetin alfa) Therapy (TREAT) is a 4000-patient, multicenter, double-blind RCT, designed to determine the impact of anemia therapy with darbepoetin alfa on mortality and nonfatal cardiovascular events in patients with CKD and type 2 diabetes mellitus. Subjects will be randomized in a 1:1 manner to either darbepoetin alfa therapy to a target hemoglobin (Hb) of 13 g/dL or control, consisting of placebo for Hb > or =9 g/dL or darbepoetin alfa for Hb <9 g/dL until Hb is again Hb > or =9 g/dL. TREAT is event-driven and has a composite primary end point comprising time to mortality and nonfatal cardiovascular events, including myocardial infarction, myocardial ischemia, stroke, and heart failure. TREAT will provide data that are critical to evolution of the management of cardiovascular risk in this high-risk population.
Mix
T-Christian H
TC
Department of Development and Medical Affairs, Amgen Inc., Thousand Oaks, Calif, USA.
Brenner
Robert M
RM
Cooper
Mark E
ME
de Zeeuw
Dick
D
Ivanovich
Peter
P
Levey
Andrew S
AS
McGill
Janet B
JB
McMurray
John J V
JJ
Parfrey
Patrick S
PS
Parving
Hans-Henrik
HH
Pereira
Brian J G
BJ
Remuzzi
Giuseppe
G
Singh
Ajay K
AK
Solomon
Scott D
SD
Stehman-Breen
Catherine
C
Toto
Robert D
RD
Pfeffer
Marc A
MA
D000740:Anemia / Q000150:complications / Q000628:therapy; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control*; D002908:Chronic Disease; D000068256:Darbepoetin alfa; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D004311:Double-Blind Method; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007674:Kidney Diseases / Q000150:complications*; D015337:Multicenter Studies as Topic / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018570:Risk Assessment; D040242:Risk Reduction Behavior
D004921:Erythropoietin; D000068256:Darbepoetin alfa