Could Ketoanalogue-supplemented Low Protein Diet Defer Dialysis in Advanced Diabetic Kidney Disease? (K-DDD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-03-31

Brief Summary

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This is a prospective single center open label randomized controlled trial aiming to assess the effectiveness and safety of a low protein diet (0.6 g/kg-day, mainly vegetarian) supplemented with ketoanalogues of essential amino-acids (sLPD) as compared to a mild protein restriction (0.8 g/kg-day, MPD) in reducing Chronic Kidney Disease (CKD) progression, with a planned total duration is of 18 months.

Adult diabetic patients with CKD stage 4+ \[estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease 4-variable (MDRD4) formula \<30 mL/min per year\], with stable renal function (historical reduction of eGFR of \< 10 ml/min-year) , proteinuria \> 3g/g creatininuria and good nutritional status (SGA A) will be enrolled.

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Detailed Description

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Adult diabetic patients with Chronic Kidney Disease (CKD) stage 4+ (estimated GFR using the Modification of Diet in Renal Disease 4-variable, MDRD4, formula \<30 mL/min per year), with stable renal function (historical reduction of eGFR of \< 10 ml/min-year), proteinuria \> 3g/g creatininuria and good nutritional status (SGA A) will be enrolled. Patients with evidence of active kidney disease (except proteinuria), with indication of etiological or pathogenic treatment, those with poor control of diabetes (HbA1c \>8%), those with uncontrolled high blood pressure (≥155/85 mmHg), those with significant co-morbidities (heart failure, active liver disease, malabsorption, active infections, inflammatory diseases requiring corticosteroids), those with uremic symptoms (pericarditis, digestive disorders ) or malnutrition (SGA B or C, serum albumin \< 3.5 g/dl) will be excluded.

Eligible patients will enter a run-in phase (3 mo), when mild protein restriction (0.8g/kg dry ideal bw) will be initiated and compliance will be evaluated twice monthly.

Those who will prove compliant during the run-in phase and still fulfill the selection criteria will be randomized 1:1 (computer-generated numbers) to receive the low protein diet (0.6 g/kg-day, mainly vegetarian) supplemented with ketoanalogues of essential amino-acids (Ketosteril 1 tb/10 kg dry bw) or to continue the mild protein restriction (0.8 g/kg-day).

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

The primary composite endpoint is the need for RRT initiation or a more than 50% reduction in the initial eGFR any time during the assessment phase. The decision to initiate RRT will be made by the Ethical Committee of the Hospital, based on the clinical and laboratory data.

The need for RRT initiation, the quality of life \[assessed by the Short Form-36 (SF-36) Questionnaire\], the decline in GFR and the correction of metabolic complications of CKD \[serum levels of urea, calcium, phosphates, serum parathyroid hormone levels, bicarbonate, potassium\] will be secondary efficacy parameters.

Parameters of nutritional status (SGA, anthropometric and biochemical parameters), compliance to the diet, occurrence of any adverse event and the number of withdrawals will be safety variables.

All the parameters will be assessed at baseline, throughout the intervention phase and at end of the study.

Conditions

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CKD Stage 4

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible patients will enter a run-in phase (3 mo), when mild protein diet (0.8g/kg dry ideal bw) will be initiated and compliance will be evaluated twice monthly.

Those who will prove compliant during the run-in phase and still fulfill the selection criteria will be randomized 1:1 (computer-generated numbers) to receive the low protein diet (0.6 g/kg-day, mainly vegetarian) supplemented with ketoanalogues of essential amino-acids (Ketosteril 1 tb/10 kg dry bw) or to continue the mild protein restriction (0.8 g/kg-day).

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Supplemented low protein diet (sLPD)

Protein restriction to a low level (0.6 g/kg-day, mainly vegetarian) + ketoanalogues of essential amino-acids supplementation (Ketosteril 1 tb/10 kg dry bw)

Group Type ACTIVE_COMPARATOR

Protein restriction

Intervention Type BEHAVIORAL

In both arms the dietary protein intake will be reduced. In the sLPD arm, the protein restriction is more severe and ketoanalogues of the essential aminoacids are offered.

Mild protein restriction diet (MPD)

Mild restriction in dietary protein intake (0.8 g/kg-day)

Group Type ACTIVE_COMPARATOR

Protein restriction

Intervention Type BEHAVIORAL

In both arms the dietary protein intake will be reduced. In the sLPD arm, the protein restriction is more severe and ketoanalogues of the essential aminoacids are offered.

Interventions

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Protein restriction

In both arms the dietary protein intake will be reduced. In the sLPD arm, the protein restriction is more severe and ketoanalogues of the essential aminoacids are offered.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* diabetic patients
* CKD stage 4+ (estimated GFR using the Modification of Diet in Renal Disease 4-variable, MDRD4, formula \<30 mL/min per year)
* stable renal function (historical reduction of eGFR of \< 10 ml/min-year)
* proteinuria \> 3g/g creatininuria
* good nutritional status (SGA A)

Exclusion Criteria

* evidence of active kidney disease (except proteinuria)
* indication for etiological or pathogenic treatment
* poor control of diabetes (HbA1c \>8%)
* uncontrolled high blood pressure (≥155/85 mmHg)
* significant co-morbidities (heart failure, active liver disease, malabsorption, active infections, inflammatory diseases requiring corticosteroids)
* uremic symptoms (pericarditis, digestive disorders
* or malnutrition (SGA B or C, serum albumin \< 3.5 g/dl)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No