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

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ClinicalTrials.gov Identifier: NCT00323713
Recruitment Status : Unknown
Verified June 2011 by Azienda Sanitaria ASL Avellino 2.
Recruitment status was:  Active, not recruiting
First Posted : May 9, 2006
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Azienda Sanitaria ASL Avellino 2

Study Description
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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).

Condition or disease Intervention/treatment Phase
Chronic Renal Insufficiency Behavioral: Very low protein diet Behavioral: Low protein diet Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2005
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to renal death, defined as the first event between start of renal replacement therapy or patient death [ Time Frame: Months ]

Secondary Outcome Measures :
  1. Compliance to diet [ Time Frame: Months ]
  2. Quality of life [ Time Frame: Months ]
  3. 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 ]
  4. 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 ]
  5. Cardiovascular mortality [ Time Frame: Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323713


Locations
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Sponsors and Collaborators
Azienda Sanitaria ASL Avellino 2
Investigators
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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
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Vincenzo Bellizzi, ASL_AV 2 - Avellino - Italy
ClinicalTrials.gov Identifier: NCT00323713    
Other Study ID Numbers: KA1-1425
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases