Efficacy of the Essential Amino Acids and Keto-Analogues on the CKD progression rate in real practice in Russia - city nephrology registry data for outpatient clinic.

Alexander Zemchenkov,Irina N Konakova

doi:10.1186/s12882-016-0281-z

Abstract

BackgroundRenal replacement therapy (RRT) is growing by 10 % per year in Russia, but pre-dialysis care which can retard CKD progression and delay the start of RRT remains limited. We evaluate the effect of Essential Amino Acids and Keto-analogues (EAA/KA) on CKD progression.MethodsThe effect of low protein diet (LPD), supplemented by EAA/KA, on GFR slope changes between first and second treatment period (five sequential visits per period) in 96 patients withs CKD Stage 3B-5 was compared to GFR slope changes in the control group of 96 patients, randomly selected from matched (by gender, age, diagnosis and CKD Stage) cohort of 320 patients from the city Registry. The mean baseline eGFR was 23 ± 9 ml/min/1.73 m2; 29 % had CKD3B, 45 % - CKD4, 26 % - CKD5.ResultsThe rate of eGFR decline changed from −2.71 ± 2.38 to −2.01 ± 2.26 ml/min/1.73 m2 per year in the treatment group and from −2.18 ± 2.01 to −2.04 ± 2.18 ml/min/1.73 m2 per year in the control group. Only in the treatment group the difference was significant (p = 0.04 and p = 0.6). Standardized effect size for intervention was significant in treatment group: −0.3 (of pooled SD), 95 % CI −0.58 ÷ −0.02 and non-significant in control group: −0.07 (−0.35 ÷ +0.22). The univariate and multivariate analysis of EAA/KA therapy effect demonstrated that it was probably more effective in patients of older age, with higher time-averaged proteinuria (PU), lower phosphate level, in patients with glomerular v. interstitial diseases, and in females. Only the latter factor was significant at pre-specified level (<0.05).ConclusionsLPD combined with EAA/KA supplementation lead to the decrease of the CKD progression both in well-designed clinical study and in real nephrology practice in wide variety diseases and settings. Registry data can be helpful to reveal patients with optimal chances for beneficial effect of LPD supplemented by EAA/KA.Trial registrationISRCTN28190556 06/05/2016.

Highlights

Renal replacement therapy (RRT) is growing by 10 % per year in Russia, but pre-dialysis care which can retard chronic kidney disease (CKD) progression and delay the start of RRT remains limited
Patients, comprising study group were selected from St-Petersburg CKD registry according following criteria: confirmed moderate GFR decline rate; patient’s compliance to diet and pharmacological therapy; and prolonged history of regular Essential Amino Acids and Keto-analogues (EAA/KA) therapy according to the data from special database, recording patient’s’ visits to drugstore for EAA/KA supplied by budgetary funded source (≥10 consecutive visits with pre-defined for each CKD stage frequency)
Evaluation of effect in treatment group The effects of lowprotein diet (LPD) supplemented by EAA/KA were evaluated during period of 10 routine visits to nephrologist following the EAA/KA prescription

Summary

Introduction

Renal replacement therapy (RRT) is growing by 10 % per year in Russia, but pre-dialysis care which can retard CKD progression and delay the start of RRT remains limited. Prevalence of RRT remains rather low, it grew from 56 per million population (pmp) in 1998 to 246 pmp in 2013 (Russian Dialysis Society Registry data [1]) and 299 pmp in 2015 (marketing data). It means that dialysis treatment becoming available for majority of patients in most regions of Russia, the more so as the average incidence rate remains rather low – 51 pmp, presumably due to younger population, lower prevalence of diabetes mellitus, lower and later CKD revealing. Lowprotein diet (LPD) is no more considered as the method to ensure survival while waiting period for RRT, but the issue of quality of life, retardation of CKD progression and delaying “the health start” of dialysis

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