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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 BMJ+Open
2016 ; 6
(3
): e010310
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Proteomic prediction and Renin angiotensin aldosterone system Inhibition
prevention Of early diabetic nephRopathy in TYpe 2 diabetic patients with
normoalbuminuria (PRIORITY): essential study design and rationale of a randomised
clinical multicentre trial
#MMPMID26936907
Lindhardt M
; Persson F
; Currie G
; Pontillo C
; Beige J
; Delles C
; von der Leyen H
; Mischak H
; Navis G
; Noutsou M
; Ortiz A
; Ruggenenti PL
; Rychlik I
; Spasovski G
; Rossing P
BMJ Open
2016[Mar]; 6
(3
): e010310
PMID26936907
show ga
INTRODUCTION: Diabetes mellitus affects 9% of the European population and
accounts for 15% of healthcare expenditure, in particular, due to excess costs
related to complications. Clinical trials aiming for earlier prevention of
diabetic nephropathy by renin angiotensin system blocking treatment in
normoalbumuric patients have given mixed results. This might reflect that the
large fraction of normoalbuminuric patients are not at risk of progression,
thereby reducing power in previous studies. A specific risk classifier based on
urinary proteomics (chronic kidney disease (CKD)273) has been shown to identify
normoalbuminuric diabetic patients who later progressed to overt kidney disease,
and may hold the potential for selection of high-risk patients for early
intervention. Combining the ability of CKD273 to identify patients at highest
risk of progression with prescription of preventive aldosterone blockade only to
this high-risk population will increase power. We aim to confirm performance of
CKD273 in a prospective multicentre clinical trial and test the ability of
spironolactone to delay progression of early diabetic nephropathy. METHODS AND
ANALYSIS: Investigator-initiated, prospective multicentre clinical trial, with
randomised double-masked placebo-controlled intervention and a prospective
observational study. We aim to include 3280 type 2 diabetic participants with
normoalbuminuria. The CKD273 classifier will be assessed in all participants.
Participants with high-risk pattern are randomised to treatment with
spironolactone 25 mg once daily, or placebo, whereas, those with low-risk pattern
will be observed without intervention other than standard of care. Treatment or
observational period is 3 years.The primary endpoint is development of confirmed
microalbuminuria in 2 of 3 first morning voids urine samples. ETHICS AND
DISSEMINATION: The study will be conducted under International Conference on
Harmonisation - Good clinical practice (ICH-GCP) requirements, ethical principles
of Declaration of Helsinki and national laws. This first new biomarker-directed
intervention trial aiming at primary prevention of diabetic nephropathy may pave
the way for personalised medicine approaches in treatment of diabetes
complications. TRIAL REGISTRATION NUMBER: NCT02040441; Pre-results.
|*Biomarkers
[MESH]
|*Renin-Angiotensin System
[MESH]
|*Research Design
[MESH]
|Adolescent
[MESH]
|Adult
[MESH]
|Aged
[MESH]
|Diabetes Mellitus, Type 2/*complications
[MESH]
|Diabetic Nephropathies/*prevention & control
[MESH]