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J Am Soc Nephrol. 2016 Jul;27(7):2164-76. doi: 10.1681/ASN.2015040369. Epub 2016 Jan 28.

Ketoanalogue-Supplemented Vegetarian Very Low-Protein Diet and CKD Progression.

Author information

1
Department of Nephrology and Internal Medicine, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania; and Department of Nephrology, "Dr. Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania lilianagarna@yahoo.com.
2
Department of Nephrology, "Dr. Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania.
3
Department of Nephrology and Internal Medicine, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania; and Department of Nephrology, "Dr. Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania.

Abstract

Dietary protein restriction may improve determinants of CKD progression. However, the extent of improvement and effect of ketoanalogue supplementation are unclear. We conducted a prospective, randomized, controlled trial of safety and efficacy of ketoanalogue-supplemented vegetarian very low-protein diet (KD) compared with conventional low-protein diet (LPD). Primary end point was RRT initiation or >50% reduction in initial eGFR. Nondiabetic adults with stable eGFR<30 ml/min per 1.73 m(2), proteinuria <1 g/g urinary creatinine, good nutritional status, and good diet compliance entered a run-in phase on LPD. After 3 months, compliant patients were randomized to KD (0.3 g/kg vegetable proteins and 1 cps/5 kg ketoanalogues per day) or continue LPD (0.6 g/kg per day) for 15 months. Only 14% of screened patients patients were randomized, with no differences between groups. Adjusted numbers needed to treat (NNTs; 95% confidence interval) to avoid composite primary end point in intention to treat and per-protocol analyses in one patient were 4.4 (4.2 to 5.1) and 4.0 (3.9 to 4.4), respectively, for patients with eGFR<30 ml/min per 1.73 m(2) Adjusted NNT (95% confidence interval) to avoid dialysis was 22.4 (21.5 to 25.1) for patients with eGFR<30 ml/min per 1.73 m(2) but decreased to 2.7 (2.6 to 3.1) for patients with eGFR<20 ml/min per 1.73 m(2) in intention to treat analysis. Correction of metabolic abnormalities occurred only with KD. Compliance to diet was good, with no changes in nutritional parameters and no adverse reactions. Thus, this KD seems nutritionally safe and could defer dialysis initiation in some patients with CKD.

KEYWORDS:

nutrition; phosphate binders; progression of chronic renal failure; renal function decline

PMID:
26823552
PMCID:
PMC4926970
[Available on 2017-07-01]
DOI:
10.1681/ASN.2015040369
[Indexed for MEDLINE]
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