Combined diabetes-renal multifactorial intervention in patients with advanced diabetic nephropathy: Proof-of-concept

Abstract

AimsTo evaluate efficacy of a multifactorial-multidisciplinary approach in delaying CKD 3–4 progression to ESRD. MethodsTwo-year proof-of-concept stratified randomized control trial conducted in an outpatient clinic of a large public hospital system. This intervention, led by a team of endocrinologists, nephrologists, nurse practitioners, and registered dietitians, integrated intensive diabetes-renal care with behavioral/dietary and pharmacological interventions. 120 low-income adults with T2DM and CKD 3–4 enrolled; 58% male, 55% African American, 23% Hispanic. ResultsPrimary outcome was progression rate from CKD 3–4 to ESRD. Fewer intervention (13%) than control (28%) developed ESRD, p<0.05. Intervention had greater albumin/creatinine ratio (ACR) decrease (62% vs. 42%, p<0.05) and A1C<7% attainment (50% vs. 30%, p<0.05) and trended toward better lipid/blood pressure control (p=NS). Significant differences between 25 ESRD and 95 ESRD-free patients were baseline eGFR (28 vs. 40ml/min/1.73m2), annual eGFR decline (15 vs. 3ml/min/year), baseline ACR (2362 vs. 1139mg/g), final ACR (2896 vs. 1201mg/g), and final A1C (6.9 vs. 7.8%). In multivariate Cox analysis, receiving the intervention reduced hazard ratio to develop ESRD (0.125, CI 0.029–0.54) as did higher baseline eGFR (0.69, CI 0.59–0.80). Greater annual eGFR decline increased hazard ratio (1.59, CI 1.34–1.87). ConclusionsThe intervention delayed ESRD. Improved A1C and ACR plus not-yet-identified variables may have influenced better outcomes. Multifactorial-multidisciplinary care may serve as a CKD 3–4 treatment paradigm.