Status:
UNKNOWN
Very Low Protein Diet and Renal Death in Chronic Kidney Disease (CKD)-ERIKA Study
Lead Sponsor:
Azienda Sanitaria ASL Avellino 2
Conditions:
Chronic Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
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 (CK...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00323713
Start Date
February 1 2005
End Date
December 1 2012
Last Update
June 27 2011
Active Locations (17)
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1
Nephrology Unit, "Moscati" Hospital
Avellino, AV, Italy, 83100
2
Nephrology Unit, S. Angelo dei Lombardi Hospital
Sant'Angelo dei Lombardi, AV, Italy, 83054
3
Nephrology Unit "A. Landolfi" Hospital
Solofra, AV, Italy, 83029
4
Nephrology Division, Medical School, University of Bari
Bari, BA, Italy, 70100