Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Restricted protein diets, Nutritional status
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.
Interventions
BEHAVIORALConventional low protein diet
DIETARY_SUPPLEMENTVery low protein diet supplemented with Ketosteril
Sponsors
Dr Carol Davila Teaching Hospital of Nephrology Bucharest
Anemia Working Group Romania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary composite endpoint | 15 months after randomization | Need for renal replacement therapy or an at least 50% reduction in the estimated glomerular filtration rate compared to randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary safety parameter - withdrawals | 18 weeks after enrolment | number of withdrawals |
| Nutritional status - biochemical marker | 18 weeks after enrolment | Serum total cholesterol |
| Safety parameter - adverse events | 18 weeks after enrolment | Occurrence of any adverse event |
| Secondary efficacy parameter | months 3-15 after randomization | The rate of decline in the estimated Glomerular Filtration Rate |
| Secondary outcome measure - nitrogen balance | 15 months after randomization | variations in serum urea |
| Secondary efficacy parameter - mineral metabolism | 15 weeks after randomization | variations in total serum calcium |
| Secondary safety parameter | 18 weeks after enrolment | Subjective Global Assessment of the nutritional status |
| Secondary outcome measure - Nutritional status | 18 weeks after enrolment | Tricipital skinfold |
| Secondary safety parameter - anthropometric measures | 18 weeks after enrolment | Mid-arm muscular circumference |
| Nutritional status - biochemical markers | 18 weeks after enrolment | serum albumin |
| Inflammation | 18 weeks after enrolment | serum level of C reactive protein |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compliance - energy intake | 18 weeks after enrolment | 3-day food diary to calculate the daily energy intake |
| Compliance - protein intake | 18 months after enrolment | urinary urea nitrogen excretion to calculate the protein intake |
Countries
Romania
Outcome results
None listed