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Sponsored by: |
Azienda Sanitaria ASL Avellino 2 |
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Information provided by: | Azienda Sanitaria ASL Avellino 2 |
ClinicalTrials.gov Identifier: | NCT00323713 |
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 |
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Chronic Renal Insufficiency |
Behavioral: Very low protein diet Behavioral: Low protein diet |
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 |
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 |
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1: Experimental
Very low protein diet
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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
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2: Active Comparator
Low protein diet
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Behavioral: Low protein diet
0.6 g of protein per kilo of body weight per day
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Severe undernutrition as indicated by :
Contact: Paolo Chiodini, MSc | ++39 081 5666021 | paolo.chiodini@unina2.it |
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 |
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 |
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 History of Changes |
Health Authority: | Italy: Ministry of Health |
Chronic renal insufficiency CKD stage 4 CKD stage 5 Protein intake |
Low protein diet Very low protein diet Ketoanalogs Renal death |
Death Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |