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

Sponsored by:	Azienda Sanitaria ASL Avellino 2
Information provided by:	Azienda Sanitaria ASL Avellino 2
ClinicalTrials.gov Identifier:	NCT00323713

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

Drug Information available for: Amino acids, branched-chain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Very Low Protein Diet Supplemented With Ketoanalogs on Renal Death in Phase 4/5 Chronic Kidney Disease (CKD) - ERIKA Study

Further study details as provided by Azienda Sanitaria ASL Avellino 2:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator Low protein diet	Behavioral: Low protein diet 0.6 g of protein per kilo of body weight per day

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323713

Contacts

Contact: Paolo Chiodini, MSc

++39 081 5666021

paolo.chiodini@unina2.it

Locations

Italy
Nephrology Division, Medical School, Second University of Naples	Recruiting
Napoli, Italy, 80138
Contact: Paolo Trucillo, MD ++39 081 2549426 pa.trucillo@hotmail.it
Principal Investigator: Giuseppe Conte, MD
Sub-Investigator: Paolo Trucillo, MD
Nephrology Unit, Castellammare Hospital	Recruiting
Castellammare di Stabia, Italy, 80053
Contact: Giovanni Somma, MD ++39 081 8729437 giosomma@aliceposta.it
Principal Investigator: Giovanni Somma, MD
Nephrology Division, Medical School, University "Federico II" of Naples	Recruiting
Napoli, Italy, 80123
Contact: Bruno Cianciaruso, MD ++39 081 7462023 cianciar@unina.it
Principal Investigator: Bruno Cianciaruso, MD
Italy, AV
Nephrology Unit "A. Landolfi" Hospital	Recruiting
Solofra, AV, Italy, 83029
Contact: Vincenzo Bellizzi, MD, PhD ++39 0825 530360 vibelliz@tin.it
Principal Investigator: Vincenzo Bellizzi, MD, PhD
Nephrology Unit, S. Angelo dei Lombardi Hospital	Recruiting
Sant' Angelo dei Lombardi, AV, Italy, 83054
Contact: Paolo Romano, MD ++39 0827 277356 mannirom@tiscali.it
Principal Investigator: Paolo Romano, MD
Nephrology Unit, "Moscati" Hospital	Recruiting
Avellino, AV, Italy, 83100
Contact: Bruno Zito, MD ++39 0825 203254 brunozito@virgilio.it
Principal Investigator: Bruno Zito, MD
Italy, BA
Nephrology Division, Medical School, University of Bari	Recruiting
Bari, BA, Italy, 70100
Contact: Francesco P Schena, MD ++39 080 5478878 fp.schena@nephro.uniba.it
Principal Investigator: Francesco P Schena, MD
Sub-Investigator: Carlo Manno, MD
Italy, BR
Nephrology Unit, Brindisi Hospital	Recruiting
Brindisi, BR, Italy, 72100
Contact: Angelo Pastore, MD ++39 0831 537355 angelo.pastore@inwind.it
Principal Investigator: Paolo Strippoli, MD
Sub-Investigator: Angelo Pastore, MD
Italy, CE
Nephrology Unit, S. Felice a Cancello Hospital	Recruiting
San Felice a Cancello, CE, Italy, 81027
Contact: Vincenzo Apperti, MD ++39 0823 803325 appertiv@yahoo.it
Principal Investigator: Vincenzo Apperti, MD
Nephrology Unit, Piedimonte Matese Hospital	Recruiting
Piedimonte Matese, CE, Italy, 81016
Contact: Salvatore Coppola, MD ++39 0823 544203 uro.net@libero.it
Principal Investigator: Salvatore Coppola, MD
Italy, CZ
Nephrology Division, Medical School, University of Catanzaro	Recruiting
Catanzaro, CZ, Italy, 88100
Contact: Giuseppe Mazza, MD ++39 0961 712457 mazzagiuseppe@hotmail.it
Principal Investigator: Giorgio Fuiano, MD
Sub-Investigator: Giuseppe Mazza, MD
Italy, FG
Nephrology Division, Medical School, University of Foggia	Recruiting
Foggia, FG, Italy, 71100
Contact: Loreto Gesualdo, MD ++39 0881 736034 l.gesualdo@unifg.it
Principal Investigator: Loreto Gesualdo, MD
Nephrology Unit, San Severo Hospital	Recruiting
San Severo, FG, Italy, 71016
Contact: Lello Dell'Aquila, MD ++39 0882 200283 lelloaquila@yahoo.it
Principal Investigator: Lello Dell'Aquila, MD
Nephrology Unit, Foggia Hospital	Recruiting
Foggia, FG, Italy, 71100
Contact: Deni Procaccini, MD ++39 0881 732051 procaccininefro@ospedaliriunitifoggia.it
Principal Investigator: Deni Procaccini, MD
Sub-Investigator: Mario Querques, MD
Italy, LE
Nephrology Unit, Galatina Hospital	Recruiting
Galatina, LE, Italy, 73013
Contact: Biagio Gigante, MD ++39 0836 529761 nefgal@libero.it
Sub-Investigator: Elio Montagna, MD
Principal Investigator: Biagio Gigante, MD
Italy, PZ
Nephrology Division, "San Carlo" Hospital	Recruiting
Potenza, PZ, Italy, 85100
Contact: Mario Procida, MD ++39 0971 613386 maprocid@ospedalesancarlo.it
Principal Investigator: Mario Procida, MD
Sub-Investigator: Maria T Lauria, MD
Italy, SA
Nephrology Unit, "Curto" Hospital	Recruiting
Polla, SA, Italy, 84035
Contact: Vincenzo Terracciano, MD ++39 0975 373368 papiter@aliceposta.it
Principal Investigator: Vincenzo Terracciano, MD

Sponsors and Collaborators

Azienda Sanitaria ASL Avellino 2

Investigators

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:

Di Iorio BR, Minutolo R, De Nicola L, Bellizzi V, Catapano F, Iodice C, Rubino R, Conte G. Supplemented very low protein diet ameliorates responsiveness to erythropoietin in chronic renal failure. Kidney Int. 2003 Nov;64(5):1822-8.

Di Iorio BR, Bellizzi V, Minutolo R, De Nicola L, Iodice C, Conte G. Supplemented very low-protein diet in advanced CRF: is it money saving? Kidney Int. 2004 Feb;65(2):742. No abstract available.

Bellizzi V, Di Iorio BR, De Nicola L, Minutolo R, Zamboli P, Trucillo P, Catapano F, Cristofano C, Scalfi L, Conte G; ERIKA Study-group. Very low protein diet supplemented with ketoanalogs improves blood pressure control in chronic kidney disease. Kidney Int. 2007 Feb;71(3):245-51. Epub 2006 Oct 11.

Responsible Party:	ASL_AV 2 - Avellino - Italy ( Dr Vincenzo Bellizzi )
Study ID Numbers:	KA1-1425
Study First Received:	May 5, 2006
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00323713
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

Study placed in the following topic categories:

Death
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 14, 2009