नेफ्रोलॉजी और थेरेप्यूटिक्स जर्नल

Real−World Data of Protein−Restricted Diets Supplemented with Ketoanalogues in Predialysis Patients− Results of a Prospective Multicentric Observation Study

Abstract

Jan Vachek, Ileana Peride, Elena Emanuela Rusu, Jiri Vlasak, Tamás Szabo, Aniko Németh, Romana Rysava, Szilvia Kazup, Jan Svojanovsky, Molnár Marta, Erzsébet Rozsnyai, Ligia Petrica, Liliana Tuta, Miklós Mihalcsó, Erzsébet Ladányi and Gábor Zakar*

Background: According to randomized controlled studies, protein-restricted diets supplemented with ketoanalogues effectively prolong the time until dialysis while maintaining nutritional status in patients with chronic kidney disease. The aim of the present study was to investigate whether such effects are also observed in real-world practice.

Methods: Multicentre, prospective, observational study over 12 months in 164 predialytic patients on a protein-restricted diet supplemented with ketoanalogues, prescribed according to recent standard of care. Main outcome variables were patients’ compliance, yearly decline in estimated glomerular filtration rate (eGFR), initiation of renal replacement therapy or 50% reduction in initial eGFR (composite endpoint), and time to dialysis start.

Results: At baseline, patients were educated about ketoanalogue intake and for the planned diet. Half of them (50.1%) required at least one further counselling over the study period. Mean daily protein intake was 0.6±0.2 g/kg body weight according to self-reported diaries. Daily ketoanalogue dose was 7.4±3.3 tablets at baseline. Adherence to ketoanalogue prescription was good with a compliance rate of ≥99% in 75% of patients. Mean eGFR remained stable throughout the observation period with a marginal decrease of 1.028±6.101 mL/min/1.73m². Notably, only 26 of 155 patients (16.8%) reached the composite endpoint. Mean time to dialysis start was 213±106 days. In general, ketoanalogues were safe and well tolerated.

Conclusion: Protein restriction with ketoanalogue supplementation was successfully managed in an everyday outpatient setting. Patient education and support were sufficient to ensure treatment compliance. These findings strengthen the evidence of protein-restricted diet supplemented with ketoanalogues to preserve renal function and nutritional status in predialysis patients over 12 months.