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

Anemia Working Group Romania

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: Very low protein diet supplemented with Ketosteril; Behavioral: Conventional low protein diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02031224

AWG13/2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Keto-diet (KD)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Very low protein diet supplemented with Ketosteril

Low Protein Diet group (LPD)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Conventional low protein diet