Very Low Protein Diet and Renal Death in Chronic Kidney Disease (CKD)-ERIKA Study

Chronic Renal Insufficiency Clinical Trial

Official title:

Effects of Very Low Protein Diet Supplemented With Ketoanalogs on Renal Death in Phase 4/5 Chronic Kidney Disease (CKD) - ERIKA Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00323713
• Other study ID #: KA1-1425
• Status: Active, not recruiting
• Phase: N/A
• First received: May 5, 2006
• Last updated: June 23, 2011
• Start date: February 2005
• Est. completion date: December 2012

Study information

• Verified date: June 2011
• Source: Azienda Sanitaria ASL Avellino 2
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: December 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients already on very low protein diet

• Change of creatinine clearance > 30% within the last 3 months

• Severe undernutrition as indicated by :

1. BMI < 20 kg/m2 in presence of serum albumin < 3.0 g/dl, or BMI < 17.5 kg/m2 whatever albumin value

2. body weight reduction > 7.5% within the last 3 months

• Severe obesity as indicated by BMI > 35 kg/m2

• 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

• Chronic obstructive respiratory diseases needing oxygen treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Very low protein diet
0.3 g of proteins per kilo of body weight per day, supplemented with a mixture of essential aminoacids and chetoacids
• Low protein diet
0.6 g of protein per kilo of body weight per day

Locations

Country	Name	City	State
Italy	Nephrology Unit, "Moscati" Hospital	Avellino	AV
Italy	Nephrology Division, Medical School, University of Bari	Bari	BA
Italy	Nephrology Unit, Brindisi Hospital	Brindisi	BR
Italy	Nephrology Unit, Castellammare Hospital	Castellammare di Stabia
Italy	Nephrology Division, Medical School, University of Catanzaro	Catanzaro	CZ
Italy	Nephrology Division, Medical School, University of Foggia	Foggia	FG
Italy	Nephrology Unit, Foggia Hospital	Foggia	FG
Italy	Nephrology Unit, Galatina Hospital	Galatina	LE
Italy	Nephrology Division, Medical School, Second University of Naples	Napoli
Italy	Nephrology Division, Medical School, University "Federico II" of Naples	Napoli
Italy	Nephrology Unit, Piedimonte Matese Hospital	Piedimonte Matese	CE
Italy	Nephrology Unit, "Curto" Hospital	Polla	SA
Italy	Nephrology Division, "San Carlo" Hospital	Potenza	PZ
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, S. Angelo dei Lombardi Hospital	Sant' Angelo dei Lombardi	AV
Italy	Nephrology Unit "A. Landolfi" Hospital	Solofra	AV

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria ASL Avellino 2

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Bellizzi V, Di Iorio BR, De Nicola L, Minutolo R, Zamboli P, Trucillo P, Catapano F, Cristofano C, Scalfi L, Conte G; ERIKA Study-group. Very low protein diet supplemented with ketoanalogs improves blood pressure control in chronic kidney disease. Kidney Int. 2007 Feb;71(3):245-51. Epub 2006 Oct 11. — View Citation

Di Iorio BR, Bellizzi V, Minutolo R, De Nicola L, Iodice C, Conte G. Supplemented very low-protein diet in advanced CRF: is it money saving? Kidney Int. 2004 Feb;65(2):742. — View Citation

Di Iorio BR, Minutolo R, De Nicola L, Bellizzi V, Catapano F, Iodice C, Rubino R, Conte G. Supplemented very low protein diet ameliorates responsiveness to erythropoietin in chronic renal failure. Kidney Int. 2003 Nov;64(5):1822-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to renal death, defined as the first event between start of renal replacement therapy or patient death		Months	Yes
Secondary	Compliance to diet		Months	No
Secondary	Quality of life		Months	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Cardiovascular mortality		Months	Yes