Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Azienda Sanitaria ASL Avellino 2.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Azienda Sanitaria ASL Avellino 2
ClinicalTrials.gov Identifier:
NCT00323713
First received: May 5, 2006
Last updated: June 23, 2011
Last verified: June 2011

May 5, 2006
June 23, 2011
February 2005
July 2011   (final data collection date for primary outcome measure)
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 ]
Time to renal death, defined as the first event between start of renal replacement therapy or patient death
Complete list of historical versions of study NCT00323713 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Compliance to diet
  • Quality of life
  • Cardiovascular morbidity, defined by left ventricular mass, blood pressure, lipid profile, calcium/phosphorus/parathormone status and Charlson comorbidity index, at the start of dialysis
  • 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
  • Cardiovascular mortality
Not Provided
Not Provided
 
Very Low Protein Diet and Renal Death in Chronic Kidney Disease (CKD)-ERIKA Study
Effects of Very Low Protein Diet Supplemented With Ketoanalogs on Renal Death in Phase 4/5 Chronic Kidney Disease (CKD) - ERIKA Study

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Renal Insufficiency
  • 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
  • Behavioral: Low protein diet
    0.6 g of protein per kilo of body weight per day
    Other Name: LPD
  • Experimental: VLPD diet
    Adavnced CKD patients (stage 4-5) on a very low protein diet
    Intervention: Behavioral: Very low protein diet
  • Active Comparator: LPD diet
    Adavnced CKD patients (stage 4-5) on a low protein diet
    Intervention: Behavioral: Low protein diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
360
December 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00323713
KA1-1425
Yes
Dr Vincenzo Bellizzi, ASL_AV 2 - Avellino - Italy
Azienda Sanitaria ASL Avellino 2
Not Provided
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
Azienda Sanitaria ASL Avellino 2
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP