Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323713
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2006-05-05
Brief Title:
Very Low Protein Diet and Renal Death in Chronic Kidney Disease CKD-ERIKA Study
Sponsor:
Azienda Sanitaria ASL Avellino 2
Organization:
Azienda Sanitaria ASL Avellino 2
Study Overview
Official Title:
Effects of Very Low Protein Diet Supplemented With Ketoanalogs on Renal Death in Phase 45 Chronic Kidney Disease CKD - ERIKA Study
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 02 gkgday 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
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 02 gkgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None