Very Low Protein Diet and Renal Death in Chronic Kidney Disease (CKD)-ERIKA Study
Recruitment status was Active, not recruiting
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Chronic Renal Insufficiency |
Behavioral: Very low protein diet Behavioral: Low protein diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Very Low Protein Diet Supplemented With Ketoanalogs on Renal Death in Phase 4/5 Chronic Kidney Disease (CKD) - ERIKA Study |
- Time to renal death, defined as the first event between start of renal replacement therapy or patient death [ Time Frame: Months ] [ Designated as safety issue: Yes ]
- Compliance to diet [ Time Frame: Months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Months ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Months ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: Months ] [ Designated as safety issue: Yes ]
- Cardiovascular mortality [ Time Frame: Months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 360 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: VLPD diet
Adavnced CKD patients (stage 4-5) on a very low protein diet
|
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
Other Name: VLPD
|
|
Active Comparator: LPD diet
Adavnced CKD patients (stage 4-5) on a low protein diet
|
Behavioral: Low protein diet
0.6 g of protein per kilo of body weight per day
Other Name: LPD
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 :
- 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
- 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
Contacts and Locations| Italy | |
| Nephrology Unit, "Moscati" Hospital | |
| Avellino, AV, Italy, 83100 | |
| Nephrology Unit, S. Angelo dei Lombardi Hospital | |
| Sant' Angelo dei Lombardi, AV, Italy, 83054 | |
| Nephrology Unit "A. Landolfi" Hospital | |
| Solofra, AV, Italy, 83029 | |
| Nephrology Division, Medical School, University of Bari | |
| Bari, BA, Italy, 70100 | |
| Nephrology Unit, Brindisi Hospital | |
| Brindisi, BR, Italy, 72100 | |
| Nephrology Unit, Piedimonte Matese Hospital | |
| Piedimonte Matese, CE, Italy, 81016 | |
| Nephrology Unit, S. Felice a Cancello Hospital | |
| San Felice a Cancello, CE, Italy, 81027 | |
| Nephrology Division, Medical School, University of Catanzaro | |
| Catanzaro, CZ, Italy, 88100 | |
| Nephrology Division, Medical School, University of Foggia | |
| Foggia, FG, Italy, 71100 | |
| Nephrology Unit, Foggia Hospital | |
| Foggia, FG, Italy, 71100 | |
| Nephrology Unit, San Severo Hospital | |
| San Severo, FG, Italy, 71016 | |
| Nephrology Unit, Galatina Hospital | |
| Galatina, LE, Italy, 73013 | |
| Nephrology Division, "San Carlo" Hospital | |
| Potenza, PZ, Italy, 85100 | |
| Nephrology Unit, "Curto" Hospital | |
| Polla, SA, Italy, 84035 | |
| Nephrology Unit, Castellammare Hospital | |
| Castellammare di Stabia, Italy, 80053 | |
| Nephrology Division, Medical School, Second University of Naples | |
| Napoli, Italy, 80138 | |
| Nephrology Division, Medical School, University "Federico II" of Naples | |
| Napoli, Italy, 80123 | |
| Study Chair: | Vincenzo Bellizzi, MD, PhD | Nephrology Unit "A. Landolfi" Hospital, Solofra (AV) Italy |
| Study Chair: | Giuseppe Conte, MD | Division of Nephrology, Medical School, Second University of Naples, Naples, Italy |
| Study Chair: | Ciro Gallo, MD | Biostatistics Unit, Medical School, Second University of Naples, Naples, Italy |
More Information
Publications:
| Responsible Party: | Dr Vincenzo Bellizzi, ASL_AV 2 - Avellino - Italy |
| ClinicalTrials.gov Identifier: | NCT00323713 History of Changes |
| Other Study ID Numbers: | KA1-1425 |
| Study First Received: | May 5, 2006 |
| Last Updated: | June 23, 2011 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Azienda Sanitaria ASL Avellino 2:
|
Chronic renal insufficiency CKD stage 4 CKD stage 5 Protein intake |
Low protein diet Very low protein diet Ketoanalogs Renal death |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Renal Insufficiency Urologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013