Early low-dose erythropoiesis-stimulating agent therapy and progression of moderate chronic kidney disease: a randomized, placebo-controlled trial.
Fliser D, Dellanna D, et al.Nephrology Dialysis Transplantation 2017; 32(2): 279-287.
Aims
To investigate the effect of early treatment with low-dose continuous erythropoiesis receptor activator (CERA) on kidney function in kidney transplant recipients and patients with type 2 diabetes with moderate chronic kidney disease (CKD).
Interventions
Participants were randomized to receive either the active treatment consisting of CERA administered once a month with starting dose of 30 mg, adjusted to maintain haemoglobin concentration within 61.5 g/dL of the baseline value, versus a matching placebo.
Participants
241 patients aged ≥ 18 years who had undergone kidney transplantation or with confirmed type 2 diabetes mellitus ≥ 6 months prior to study entry with an estimated glomerular filtration rate (eGFR) between 30 and 59 mL/min/1.73 m2, urinary albumin–creatinine ratio <3000 mg/g creatinine or total
Outcomes
The primary outcome measured was the annual change in eGFR using the abbreviated Modification of Diet in Renal Disease (MDRD) formula. Secondary outcomes included the annual change in eGFR using the Chronic Kidney Disease Epidemiology Collaboration formula, and changes from baseline in serum creatinine, urinary albumin–creatinine ratio and serum cystatin C.
Follow-up
2 years
CET Conclusions
This was a carefully done trial in patients with either type 2 diabetes or a renal transplant with modest deterioration in renal function. Patients were blind to their treatment and were randomised to receive either low dose continuous erythropoietin receptor activator (CERA) monthly, or a placebo. The measurement of renal function, which was the primary end point, used estimated GFR with MDRD and the conclusions were that these patients with moderate chronic kidney disease and type 2 diabetes, or a previous kidney transplant and modest dysfunction, showed stable renal function unaffected by the administration of CERA. There was also no meaningful effect of treatment on albuminuria, an important surrogate marker of kidney injury. However, renal function did not deteriorate in the placebo arm of the trial, which meant that the trial was not able to show that CERA prevented deterioration of renal function.
Data analysis
Modified intention-to-treat analysis
Trial registration
Clinicaltrials.gov - NCT01194154