Chronic Renal InsufficiencyNCT00323713
Very Low Protein Diet and Renal Death in Chronic Kidney Disease (CKD)-ERIKA Study
A study testing Very low protein diet and Low protein diet in people with Chronic Renal Insufficiency, run by Azienda Sanitaria ASL Avellino 2 at 17 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Insufficiency
- What is being tested?
- Very low protein diet and Low protein diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 17 sitesItaly
- Study dates
- Feb 2005to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Italy17 sites
Nephrology Unit, "Moscati" Hospital
Avellino, AV, 83100
Nephrology Division, Medical School, University of Bari
Bari, BA, 70100
Nephrology Unit, Brindisi Hospital
Brindisi, BR, 72100
Nephrology Unit, Castellammare Hospital
Castellammare di Stabia, 80053
Nephrology Division, Medical School, University of Catanzaro
Catanzaro, CZ, 88100
Nephrology Division, Medical School, University of Foggia
Foggia, FG, 71100
Nephrology Unit, Foggia Hospital
Foggia, FG, 71100
Nephrology Unit, Galatina Hospital
Galatina, LE, 73013
Nephrology Division, Medical School, University "Federico II" of Naples
Naples, 80123
Nephrology Division, Medical School, Second University of Naples
Naples, 80138
Nephrology Unit, Piedimonte Matese Hospital
Piedimonte Matese, CE, 81016
Nephrology Unit, "Curto" Hospital
Polla, SA, 84035
Nephrology Division, "San Carlo" Hospital
Potenza, PZ, 85100
Nephrology Unit, S. Felice a Cancello Hospital
San Felice A Cancello, CE, 81027
Nephrology Unit, San Severo Hospital
San Severo, FG, 71016
Nephrology Unit, S. Angelo dei Lombardi Hospital
Sant'Angelo dei Lombardi, AV, 83054
Nephrology Unit "A. Landolfi" Hospital
Solofra, AV, 83029
About this 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
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).
Read the 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.
- Conditions
- Chronic Renal Insufficiency
- Being tested
- Very low protein diet, Low protein diet
- Keywords
- Chronic renal insufficiency, CKD stage 4, CKD stage 5, Protein intake, Low protein diet, Very low protein diet, Ketoanalogs, Renal death
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low protein dietBehavioural
Also called VLPD
0.3 g of proteins per kilo of body weight per day, supplemented with a mixture of essential aminoacids and chetoacids
Low protein dietBehavioural
Also called LPD
0.6 g of protein per kilo of body weight per day
| Study group | Role | What they receive |
|---|---|---|
| VLPD diet | Experimental | Adavnced CKD patients (stage 4-5) on a very low protein diet Receives: Behavioral: Very low protein diet |
| LPD diet | Active comparator | Adavnced CKD patients (stage 4-5) on a low protein diet Receives: Behavioral: Low protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to renal death, defined as the first event between start of renal replacement therapy or patient death
Measured: Months
Secondary outcomes (5)
Compliance to diet
Measured: Months
Quality of life
Measured: 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
Measured: 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
Measured: Months
Cardiovascular mortality
Measured: Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startFeb 2005
- Primary completionJul 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria ASL Avellino 2
- Sponsor type
- University, hospital or other
- Investigators
- Vincenzo Bellizzi, MD, PhD, Study chair, Nephrology Unit "A. Landolfi" Hospital, Solofra (AV) ItalyGiuseppe Conte, MD, Study chair, Division of Nephrology, Medical School, Second University of Naples, Naples, ItalyCiro Gallo, MD, Study chair, Biostatistics Unit, Medical School, Second University of Naples, Naples, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323713
- Sponsor's protocol ID
- KA1-1425
- Status last verified
- Jun 2011
- First submitted
- 5 May 2006
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1046/j.1523-1755.2003.00282.x.
PubMed 14531817Di 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.
PubMed 14717953Bellizzi 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.
PubMed 17035939Hahn 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.
PubMed 33118160
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Very Low Protein Diet Supplemented With Ketoanalogs on Renal Death in Phase 4/5 Chronic Kidney Disease (CKD) - ERIKA Study
- ClinicalTrials.gov ID
- NCT00323713
- Acronym / sponsor ID
- KA1-1425
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Azienda Sanitaria ASL Avellino 2University, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLPD diet | Experimental | Behavioral: Very low protein dietAdavnced CKD patients (stage 4-5) on a very low protein diet |
| LPD diet | Active comparator | Behavioral: Low protein dietAdavnced CKD patients (stage 4-5) on a low protein diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- Patients already on very low protein diet
- Change of creatinine clearance > 30% within the last 3 months
- Severe undernutrition as indicated by :
- Severe obesity as indicated by BMI > 35 kg/m2
- Pregnancy or feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low protein dietAlso: VLPD0.3 g of proteins per kilo of body weight per day, supplemented with a mixture of essential aminoacids and chetoacids | Behavioural | VLPD diet |
| Low protein dietAlso: LPD0.6 g of protein per kilo of body weight per day | Behavioural | LPD diet |
Primary outcome
Time to renal death, defined as the first event between start of renal replacement therapy or patient death
Time frame: Months
5 secondary outcomes
Compliance to diet
Time frame: Months
Quality of life
Time frame: 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
Time frame: 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
Time frame: Months
Cardiovascular mortality
Time frame: Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- Background: PubMed 14531817Di 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.
- Background: PubMed 14717953Di 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.
- Background: PubMed 17035939Bellizzi 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.
- Derived from this study: PubMed 33118160Hahn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Bellizzi, MD, PhD study chair
Nephrology Unit "A. Landolfi" Hospital, Solofra (AV) Italy
Giuseppe Conte, MD study chair
Division of Nephrology, Medical School, Second University of Naples, Naples, Italy
Ciro Gallo, MD study chair
Biostatistics Unit, Medical School, Second University of Naples, Naples, Italy
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low protein diet and Low protein diet in people with Chronic Renal Insufficiency, run by Azienda Sanitaria ASL Avellino 2 at 17 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to renal death, defined as the first event between start of renal replacement therapy or patient death (time frame: Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00323713, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.