Status:
UNKNOWN
Could Ketoanalogue-supplemented Low Protein Diet Defer Dialysis in Advanced Diabetic Kidney Disease? (K-DDD)
Lead Sponsor:
Anemia Working Group Romania
Conditions:
CKD Stage 4
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 ketoa...
Detailed Description
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 fu...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03415074
Start Date
October 1 2019
End Date
March 31 2023
Last Update
February 24 2020
Active Locations (1)
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1
"Dr Carol Davila" Teaching Hospital of Nephrology
Bucharest, Romania, 010731