Supplemented Very Low Protein Diet and the Progression of Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— KETOPROG  

Official title:

Effect of Very Low Protein Diet Supplemented With Ketoanalogues of the Essential Amino Acids on the Progression of Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031224
• Other study ID #: AWG13/2007
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2014
• Last updated: December 21, 2017
• Start date: March 2008
• Est. completion date: August 2014

Study information

• Verified date: December 2017
• Source: Anemia Working Group Romania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Conventional low protein diet

Dietary Supplement:
• Very low protein diet supplemented with Ketosteril

Locations

Country	Name	City	State
Romania	"Dr Carol Davila" Teaching Hospital of Nephrology	Bucharest

Sponsors (2)

Lead Sponsor	Collaborator
Anemia Working Group Romania	Dr Carol Davila Teaching Hospital of Nephrology Bucharest

Country where clinical trial is conducted

Romania, 

References & Publications (1)

Mircescu G, Gârneata L, Stancu SH, Capusa C. Effects of a supplemented hypoproteic diet in chronic kidney disease. J Ren Nutr. 2007 May;17(3):179-88. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance - protein intake	urinary urea nitrogen excretion to calculate the protein intake	18 months after enrolment
Other	Compliance - energy intake	3-day food diary to calculate the daily energy intake	18 weeks after enrolment
Primary	Primary composite endpoint	Need for renal replacement therapy or an at least 50% reduction in the estimated glomerular filtration rate compared to randomization	15 months after randomization
Secondary	Secondary efficacy parameter	The rate of decline in the estimated Glomerular Filtration Rate	months 3-15 after randomization
Secondary	Secondary outcome measure - nitrogen balance	variations in serum urea	15 months after randomization
Secondary	Secondary efficacy parameter - mineral metabolism	variations in total serum calcium	15 weeks after randomization
Secondary	Secondary efficacy parameter	variations in serum phosphate level	15 weeks after randomization
Secondary	Secondary efficacy parameter	variations in serum bicarbonate	15 weeks after randomization
Secondary	Secondary safety parameter	Subjective Global Assessment of the nutritional status	18 weeks after enrolment
Secondary	Secondary safety parameter	Body Mass Index	18 weeks after enrolment
Secondary	Secondary outcome measure - Nutritional status	Tricipital skinfold	18 weeks after enrolment
Secondary	Secondary safety parameter - anthropometric measures	Mid-arm muscular circumference	18 weeks after enrolment
Secondary	Nutritional status - biochemical markers	serum albumin	18 weeks after enrolment
Secondary	Inflammation	serum level of C reactive protein	18 weeks after enrolment
Secondary	Nutritional status - biochemical marker	Serum total cholesterol	18 weeks after enrolment
Secondary	Secondary safety parameter	Serum potassium level	18 weeks after enrolment
Secondary	Secondary safety parameter	liver enzymes: Aspartate Aminotransferase, Alanine Transaminase	18 weeks after enrolment
Secondary	Safety parameter - adverse events	Occurrence of any adverse event	18 weeks after enrolment
Secondary	Secondary safety parameter - withdrawals	number of withdrawals	18 weeks after enrolment