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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Anemia Working Group Romania
Sponsor:
Collaborator:
Dr Carol Davila Teaching Hospital of Nephrology Bucharest
Information provided by (Responsible Party):
Liliana Garneata, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT02031224
First received: January 7, 2014
Last updated: August 23, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Behavioral: Conventional low protein diet
Dietary Supplement: Very low protein diet supplemented with Ketosteril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Very Low Protein Diet Supplemented With Ketoanalogues of the Essential Amino Acids on the Progression of Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Anemia Working Group Romania:

Primary Outcome Measures:
  • Primary composite endpoint [ Time Frame: 15 months after randomization ] [ Designated as safety issue: No ]
    Need for renal replacement therapy or an at least 50% reduction in the estimated glomerular filtration rate compared to randomization


Secondary Outcome Measures:
  • Secondary efficacy parameter [ Time Frame: months 3-15 after randomization ] [ Designated as safety issue: No ]
    The rate of decline in the estimated Glomerular Filtration Rate

  • Secondary outcome measure - nitrogen balance [ Time Frame: 15 months after randomization ] [ Designated as safety issue: No ]
    variations in serum urea

  • Secondary efficacy parameter - mineral metabolism [ Time Frame: 15 weeks after randomization ] [ Designated as safety issue: No ]
    variations in total serum calcium

  • Secondary efficacy parameter [ Time Frame: 15 weeks after randomization ] [ Designated as safety issue: No ]
    variations in serum phosphate level

  • Secondary efficacy parameter [ Time Frame: 15 weeks after randomization ] [ Designated as safety issue: No ]
    variations in serum bicarbonate

  • Secondary safety parameter [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    Subjective Global Assessment of the nutritional status

  • Secondary safety parameter [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    Body Mass Index

  • Secondary outcome measure - Nutritional status [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    Tricipital skinfold

  • Secondary safety parameter - anthropometric measures [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    Mid-arm muscular circumference

  • Nutritional status - biochemical markers [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    serum albumin

  • Inflammation [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    serum level of C reactive protein

  • Nutritional status - biochemical marker [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    Serum total cholesterol

  • Secondary safety parameter [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    Serum potassium level

  • Secondary safety parameter [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    liver enzymes: Aspartate Aminotransferase, Alanine Transaminase

  • Safety parameter - adverse events [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    Occurrence of any adverse event

  • Secondary safety parameter - withdrawals [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    number of withdrawals


Other Outcome Measures:
  • Compliance - protein intake [ Time Frame: 18 months after enrolment ] [ Designated as safety issue: Yes ]
    urinary urea nitrogen excretion to calculate the protein intake

  • Compliance - energy intake [ Time Frame: 18 weeks after enrolment ] [ Designated as safety issue: Yes ]
    3-day food diary to calculate the daily energy intake


Estimated Enrollment: 250
Study Start Date: March 2008
Estimated Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Keto-diet (KD)
Patients in the intervention arm (KD group) will receive a vegetarian very low protein diet (0.3 g proteins/kg ideal body weight per day) supplemented with ketoanalogues of essential amino acids (Ketosteril®, Fresenius Kabi, Bad Homburg, Germany), 1 capsule for every 5 kg of ideal dry body weight per day.
Dietary Supplement: Very low protein diet supplemented with Ketosteril
Other Name: SVLPD, Keto-diet
Active Comparator: Low Protein Diet group (LPD)

The patients in the control arm (LPD group) will continue their conventional low protein diet, with 0.6 g/kg per day (including high biological value proteins).

The total recommended energy intake is of 30 kcal/kg of ideal dry body weight per day in both arms.

Behavioral: Conventional low protein diet
Other Names:
  • LPD
  • Hypoproteic diet

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031224

Contacts
Contact: Liliana Garneata, MD, PhD +40722619358 lilianagarna@yahoo.com

Locations
Romania
"Dr Carol Davila" Teaching Hospital of Nephrology Recruiting
Bucharest, Romania, 010731
Contact: Liliana Garneata, MD, PhD    +40722619358    lilianagarna@yahoo.com   
Sub-Investigator: Liliana Garneata, MD, PhD         
Principal Investigator: Gabriel Mircescu, Professor, MD, PhD         
Sub-Investigator: Alexandra Corbu Stancu, MD         
Sub-Investigator: Diana Ramona Dragomir, MD         
Sponsors and Collaborators
Anemia Working Group Romania
Dr Carol Davila Teaching Hospital of Nephrology Bucharest
  More Information

Publications:
Responsible Party: Liliana Garneata, Assistant Professor of Nephrology, MD, PhD, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT02031224     History of Changes
Other Study ID Numbers: AWG13/2007
Study First Received: January 7, 2014
Last Updated: August 23, 2014
Health Authority: Romania: Ethics Committee

Keywords provided by Anemia Working Group Romania:
Chronic Kidney Disease
Restricted protein diets
Nutritional status

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014