Very Low Protein Diet and Renal Death in Chronic Kidney Disease (CKD)-ERIKA Study
- Conditions
- Chronic Renal Insufficiency
- Interventions
- Behavioral: Very low protein dietBehavioral: Low protein diet
- Registration Number
- NCT00323713
- Lead Sponsor
- Azienda Sanitaria ASL Avellino 2
- Brief Summary
The purpose of this study is to determine whether the use of a very low protein diet is effective in delaying the start of chronic dialysis treatment in patients affected by chronic kidney disease (CKD).
- Detailed Description
The prevalence of chronic dialysis patients is increasing worldwide because of the rising incidence of end stage renal disease, it is burdened by high cardiovascular risk, it is associated with a very high morbidity and mortality and it determines enormous costs for the community.
The improvement in the management of metabolic and cardiovascular complication associated to chronic kidney disease (CKD) since the early stages of the disease becomes mandatory in order to delay the start of dialysis and to ameliorate the whole patient outcome.
Dietary protein restriction represents a basic therapeutic approach in CKD, by reducing the accumulation of nitrogen catabolic substances, the phosphorus retention and the consequent hyperparathyroidism, the metabolic acidosis, the salt intake and the consequent hypertension, the proteinuria, and by improving the anemia and the glycemic tolerance, but the effects of the low protein diet on renal failure progression rate have not been definitely demonstrated.
Dietary effective reduction of just 0.2 g/kg/day of proteins is effective in ameliorating blood urea nitrogen, metabolic acidosis and hyperphosphoremia, and the very low protein diet (VLPD) allows a further improving of the metabolic control of uremia, it is safe, not affecting the nutritional status, and it is cost saving. VLPD has been suggested to delay the start of renal replacement therapy with respect to standard low protein diet, by mean of either secondary analysis of clinical trials or retrospective analysis.
Large randomized clinical trials (RCT) on this issue lack, and the effect of VLPD on renal death remain to be addressed. As well, information on patients' compliance to VLPD prescription and on the impact of VLPD on the quality of life are needed. Finally, also the effects of VLPD on both cardiovascular risk factors and mortality remain to be completely evaluated.
The primary aim of this study is to evaluate, by mean of a RCT, the effect of the very low protein diet on the renal death in renal patients affected by chronic renal insufficiency of moderate to advanced degree (CKD stages 4 and 5). Secondary aims are to evaluate the effect of VLPD on cardiovascular risk factors, morbidity and mortality, the adherence to VLPD, and the relationship between VLPD and quality of life.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 360
- Patients with chronic renal insufficiency in stage CKD 4 and 5 (GFR < 30 ml/min/1.73m2, estimated by the 24-hours creatinine clearance) receiving conservative treatment for CKD
- Incident patients with chronic renal insufficiency in stage CKD 4 and 5 (GFR < 30 ml/min/1.73m2, estimated by the 24-hours creatinine clearance), provided stable renal function determined by two 24-hour measurements of creatinine clearance 2 weeks a part
-
Patients already on very low protein diet
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Change of creatinine clearance > 30% within the last 3 months
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Severe undernutrition as indicated by :
- BMI < 20 kg/m2 in presence of serum albumin < 3.0 g/dl, or BMI < 17.5 kg/m2 whatever albumin value
- body weight reduction > 7.5% within the last 3 months
-
Severe obesity as indicated by BMI > 35 kg/m2
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Pregnancy or feeding
-
Chronic treatment with steroid or cytotoxic drugs
-
Fast progressing glomerulonephritis
-
Active SLE and vasculitis
-
Cardiac failure stage IV NYHA
-
Advanced liver cirrhosis
-
Active cancer diseases
-
Severe encephalopathy associated with lack of spontaneous feeding
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Chronic obstructive respiratory diseases needing oxygen treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VLPD diet Very low protein diet Adavnced CKD patients (stage 4-5) on a very low protein diet LPD diet Low protein diet Adavnced CKD patients (stage 4-5) on a low protein diet
- Primary Outcome Measures
Name Time Method Time to renal death, defined as the first event between start of renal replacement therapy or patient death Months
- Secondary Outcome Measures
Name Time Method Compliance to diet Months Quality of life Months Cardiovascular morbidity, defined by angina, heart failure, myocardial infarction, left ventricular mass, stroke, blood pressure, lipid profile, calcium/phosphorus/parathormone status and Charlson comorbidity index, at the start of dialysis Months Nutritional status, defined by anthropo-plicometry, biochemistry, body bioimpedance analysis (BIA), subjective global nutritional assessment (SGA), at the start and during the 1st year of dialysis Months Cardiovascular mortality Months
Trial Locations
- Locations (17)
Nephrology Unit, "Moscati" Hospital
🇮🇹Avellino, AV, Italy
Nephrology Unit, S. Angelo dei Lombardi Hospital
🇮🇹Sant' Angelo dei Lombardi, AV, Italy
Nephrology Unit "A. Landolfi" Hospital
🇮🇹Solofra, AV, Italy
Nephrology Division, Medical School, University of Bari
🇮🇹Bari, BA, Italy
Nephrology Unit, Brindisi Hospital
🇮🇹Brindisi, BR, Italy
Nephrology Unit, Piedimonte Matese Hospital
🇮🇹Piedimonte Matese, CE, Italy
Nephrology Unit, S. Felice a Cancello Hospital
🇮🇹San Felice a Cancello, CE, Italy
Nephrology Unit, San Severo Hospital
🇮🇹San Severo, FG, Italy
Nephrology Unit, Foggia Hospital
🇮🇹Foggia, FG, Italy
Nephrology Unit, Galatina Hospital
🇮🇹Galatina, LE, Italy
Nephrology Unit, "Curto" Hospital
🇮🇹Polla, SA, Italy
Nephrology Division, "San Carlo" Hospital
🇮🇹Potenza, PZ, Italy
Nephrology Division, Medical School, University "Federico II" of Naples
🇮🇹Napoli, Italy
Nephrology Division, Medical School, Second University of Naples
🇮🇹Napoli, Italy
Nephrology Division, Medical School, University of Foggia
🇮🇹Foggia, FG, Italy
Nephrology Unit, Castellammare Hospital
🇮🇹Castellammare di Stabia, Italy
Nephrology Division, Medical School, University of Catanzaro
🇮🇹Catanzaro, CZ, Italy