Microalbuminuria: target for renoprotective therapy PRO.
Drug efficacy is ascertained using clinically meaningful outcomes that directly affect the well-being of patients. However, in studies of chronic kidney disease progression, clinically meaningful outcomes like end-stage renal disease take a long time to occur. The use of surrogate end points/markers as replacement for clinical outcomes is tempting as it may reduce sample size requirements, shorten follow-up time, facilitate trial conduct, and allow the performance of intervention trials in earlier stages of kidney disease to be carried out. We here reviewed recent data supporting the use of microalbuminuria as a valid surrogate end point in clinical trials of chronic kidney disease. We provide data that albuminuria is associated with worse renal prognosis and that pharmacological treatment aimed to reduce albuminuria levels delays the progression of renal disease and the occurrence of clinical outcomes. Furthermore, we review new studies showing that albumin is not only an inert molecule but also directly affects the function of several cell types in the kidney and may have a pathogenic role in renal disease. Accepting microalbuminuria as a surrogate marker for renal outcomes will lead to less resource-consuming hard outcome trials, will accelerate the development of drugs for chronic kidney disease, and enable earlier access of these drugs to individual patients.
Department of Clinical Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Sara S
SS
Roscioni
Department of Clinical Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Hiddo J
HJ
Lambers Heerspink
Department of Clinical Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Dick
D
de Zeeuw
D000419:Albuminuria / Q000188:drug therapy* / Q000503:physiopathology / Q000652:urine; D015415:Biomarkers / Q000652:urine; D002986:Clinical Trials as Topic; D003404:Creatinine / Q000652:urine; D018450:Disease Progression; D006801:Humans; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy* / Q000503:physiopathology / Q000652:urine
D015415:Biomarkers; D003404:Creatinine