Clinical trial NCT02031224: Supplemented Very Low Protein Diet and the Progression of Chronic Kidney Disease
Official title: Effect of Very Low Protein Diet Supplemented With Ketoanalogues of the Essential Amino Acids on the Progression of Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Restricted protein diets
Nutritional status
Lead sponsor: Anemia Working Group Romania
Sponsor class: OTHER
Collaborators: name: Dr Carol Davila Teaching Hospital of Nephrology Bucharest
First posted: 2014-01-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective single center randomized controlled trial with a total duration of 18 months aiming to evaluate the effectiveness and the safety of a very low protein diet supplemented with ketoanalogues of essential aminoacids in reducing the progression of chronic kidney disease (CKD) in patients with advanced CKD.

Detailed description: All eligible patients who will give informed consent will be screened. Those meeting the selection criteria will be enrolled and will enter a 3-month run-in phase during which a conventional LPD will be prescribed in all patients.

At the end of this phase, the subjects still fulfilling all the selection criteria will be randomized in a 1:1 ratio to receive the KD or to continue the conventional LPD for a total duration of 15 months.

Nineteen blood and urine samplings are scheduled for each patient, to be drawn monthly. The laboratory reports include the nitrogen compounds, calcium-phosphorus metabolism parameters, acid-base balance, biochemical nutritional markers, serum C-reactive protein, hemoglobin, blood cell count, and biochemical safety parameters (sodium, potassium, liver enzymes, and bilirubin).

The anthropometric measurements and subjective global assessment will be evaluated at enrolment, at randomization, and every 3 months thereafter.

The compliance with the prescribed diet (protein and energy intake) will be assessed monthly during the run-in phase, weekly for the first month after randomization, every 4 weeks during the next 6 months, and every 3 months thereafter.

The blood pressure levels, drugs required for the therapy of hypertension, acidosis and mineral metabolism disorders, and occurrence of adverse events will be recorded monthly.

Eligibility criteria: Inclusion Criteria:

* adult non-diabetic patients
* stage 4-5 CKD not on dialysis (estimated glomerular filtration by Modification of Diet in Renal Disease formula \< 30 mL/min per year
* stable renal function at least 12 weeks before enrollment
* well-controlled arterial blood pressure
* proteinuria less than 1 g/g urinary creatinine
* good nutritional status
* declared and anticipated good compliance with the prescribed diet

Exclusion Criteria:

* poorly controlled arterial blood pressure (≥145/85 mm Hg)
* relevant comorbid conditions (diabetes mellitus, heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)
* uremic complications (pericarditis, polyneuropathy)
* feeding inability (anorexia, nausea)

Primary outcomes:
measure: Primary composite endpoint
timeFrame: 15 months after randomization
Secondary outcomes:
measure: Secondary efficacy parameter
timeFrame: months 3-15 after randomization
measure: Secondary outcome measure - nitrogen balance
timeFrame: 15 months after randomization
measure: Secondary efficacy parameter - mineral metabolism
timeFrame: 15 weeks after randomization
measure: Secondary efficacy parameter
timeFrame: 15 weeks after randomization
measure: Secondary efficacy parameter
timeFrame: 15 weeks after randomization
measure: Secondary safety parameter
timeFrame: 18 weeks after enrolment
measure: Secondary safety parameter
timeFrame: 18 weeks after enrolment
measure: Secondary outcome measure - Nutritional status
timeFrame: 18 weeks after enrolment
measure: Secondary safety parameter - anthropometric measures
timeFrame: 18 weeks after enrolment
measure: Nutritional status - biochemical markers
timeFrame: 18 weeks after enrolment
measure: Inflammation
timeFrame: 18 weeks after enrolment
measure: Nutritional status - biochemical marker
timeFrame: 18 weeks after enrolment
measure: Secondary safety parameter
timeFrame: 18 weeks after enrolment
measure: Secondary safety parameter
timeFrame: 18 weeks after enrolment
measure: Safety parameter - adverse events
timeFrame: 18 weeks after enrolment
measure: Secondary safety parameter - withdrawals
timeFrame: 18 weeks after enrolment
Other outcomes:
measure: Compliance - protein intake
timeFrame: 18 months after enrolment
measure: Compliance - energy intake
timeFrame: 18 weeks after enrolment
Locations:
city: Bucharest
country: Romania
facility: "Dr Carol Davila" Teaching Hospital of Nephrology
Study officials:
affiliation: Carol Davila University of Medicine and Pharmacy
name: Gabriel Mircescu, Prof
role: STUDY_CHAIR
References:
citation: Mircescu G, Garneata L, Stancu SH, Capusa C. Effects of a supplemented hypoproteic diet in chronic kidney disease. J Ren Nutr. 2007 May;17(3):179-88. doi: 10.1053/j.jrn.2006.12.012.
citation: 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.