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

NCT00323713 | Unknown DMC

• 1 other identifier: KA1-1425
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 17

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).

Conditions

Chronic Renal Insufficiency

Keywords

Chronic renal insufficiency; CKD stage 4; CKD stage 5; Protein intake; Low protein diet; Very low protein diet; Ketoanalogs; Renal death

Outcome Measures

Primary Outcomes (1)

• Time to renal death, defined as the first event between start of renal replacement therapy or patient death

  Months

Secondary Outcomes (5)

• Compliance to diet

  Months

• Quality of life

  Months

• 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

  Months

• 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

  Months

• Cardiovascular mortality

  Months

Study Arms (2)

VLPD diet

EXPERIMENTAL

Adavnced CKD patients (stage 4-5) on a very low protein diet

Behavioral: Very low protein diet

LPD diet

ACTIVE COMPARATOR

Adavnced CKD patients (stage 4-5) on a low protein diet

Behavioral: Low protein diet

Interventions

Very low protein diet BEHAVIORAL

0.3 g of proteins per kilo of body weight per day, supplemented with a mixture of essential aminoacids and chetoacids

Also known as: VLPD

VLPD diet

Low protein diet BEHAVIORAL

0.6 g of protein per kilo of body weight per day

Also known as: LPD

LPD diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria ASL Avellino 2: lead

Study Sites (17)

Nephrology Unit, "Moscati" Hospital

Avellino, AV, 83100, Italy

Location

Nephrology Unit, S. Angelo dei Lombardi Hospital

Sant'Angelo dei Lombardi, AV, 83054, Italy

Location

Nephrology Unit "A. Landolfi" Hospital

Solofra, AV, 83029, Italy

Location

Nephrology Division, Medical School, University of Bari

Bari, BA, 70100, Italy

Location

Nephrology Unit, Brindisi Hospital

Brindisi, BR, 72100, Italy

Location

Nephrology Unit, Piedimonte Matese Hospital

Piedimonte Matese, CE, 81016, Italy

Location

Nephrology Unit, S. Felice a Cancello Hospital

San Felice A Cancello, CE, 81027, Italy

Location

Nephrology Division, Medical School, University of Catanzaro

Catanzaro, CZ, 88100, Italy

Location

Nephrology Division, Medical School, University of Foggia

Foggia, FG, 71100, Italy

Location

Nephrology Unit, Foggia Hospital

Foggia, FG, 71100, Italy

Location

Nephrology Unit, San Severo Hospital

San Severo, FG, 71016, Italy

Location

Nephrology Unit, Galatina Hospital

Galatina, LE, 73013, Italy

Location

Nephrology Division, "San Carlo" Hospital

Potenza, PZ, 85100, Italy

Location

Nephrology Unit, "Curto" Hospital

Polla, SA, 84035, Italy

Location

Nephrology Unit, Castellammare Hospital

Castellammare di Stabia, 80053, Italy

Location

Nephrology Division, Medical School, University "Federico II" of Naples

Napoli, 80123, Italy

Location

Nephrology Division, Medical School, Second University of Naples

Napoli, 80138, Italy

Location

Related Publications (4)

• 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. doi: 10.1046/j.1523-1755.2003.00282.x.

  PMID: 14531817 BACKGROUND

• 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. doi: 10.1111/j.1523-1755.2004.404_2.x. No abstract available.

  PMID: 14717953 BACKGROUND

• 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. doi: 10.1038/sj.ki.5001955. Epub 2006 Oct 11.

  PMID: 17035939 BACKGROUND

• Hahn D, Hodson EM, Fouque D. Low protein diets for non-diabetic adults with chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 29;10(10):CD001892. doi: 10.1002/14651858.CD001892.pub5.

  PMID: 33118160 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: February 1, 2005
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2012
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

IT (17)