The Primavera study protocol design: evaluating the effect of continuous erythropoiesis receptor activator (C.E.R.A.) on renal function in non-anemic patients with chronic kidney disease.
Fliser D, Dellanna F, et al.Contemporary Clinical Trials 32(6): 786-792, 2011.
Aims
To evaluate whether erythropoiesis stimulating agent’s treatment could ameliorate progression of chronic kidney disease in non-anemic patients.
Interventions
Continuous erythropoietin receptor activator versus matching placebo.
Participants
400 patients with type 2 diabetes or who have undergone kidney transplantation.
Outcomes
Primary efficacy is the change in estimated glomerular filtration rate from baseline to month 24. Secondary outcomes included change in urinary albumin to creatinine ratio, change in serum cystatin C from baseline, change in serum creatinine.
Follow-up
2 years
CET Conclusions
This is the protocol for the Primavera study designed to investigate whether patients with a kidney transplant or with type 2 diabetes who have chronic kidney disease, stage 3, benefit in terms of renal function from the infusion of erythropoietin receptor activator. This will be compared with the administration of a placebo. The planned sample size is 400 patients, 200 type 2 diabetics and 200 transplant recipients.
Quality notes
This is a study protocol and therefore quality assessment is not appropriate.
Trial registration
NCT01194154 (ClinicalTrials.gov)