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

NCT03415074 | Unknown DMC

• 1 other identifier: AnemiaWGRomania
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

CKD Stage 4

Keywords

low protein diet; Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• CKD progression

  Percentage of patients requiring RRT initiation or a more than 50% reduction in the initial eGFR at anytime during the study

  15 months

Secondary Outcomes (18)

• Need for renal replacement therapy (RRT)

  15 months

• Patients' Quality of life

  at baseline and than every 3 months up to 15 months

• Decline in eGFR

  monthly up to 15 months

• Correction of nitrogen balance

  monthly up to 15 months

• Correction of metabolic acidosis

  monthly up to 15 months

Study Arms (2)

Supplemented low protein diet (sLPD)

ACTIVE COMPARATOR

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)

Behavioral: Protein restriction

Mild protein restriction diet (MPD)

ACTIVE COMPARATOR

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

Behavioral: Protein restriction

Interventions

Protein restriction 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); Supplemented low protein diet (sLPD)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Anemia Working Group Romania: lead

Study Sites (1)

"Dr Carol Davila" Teaching Hospital of Nephrology

Bucharest, 010731, Romania

RECRUITING

Related Publications (1)

• Mihalache A, Garneata L, Mocanu CA, Simionescu TP, Mircescu G. Low-salt low-protein diet and blood pressure control in patients with advanced diabetic kidney disease and heavy proteinuria. Int Urol Nephrol. 2021 Jun;53(6):1197-1207. doi: 10.1007/s11255-020-02717-2. Epub 2021 Jan 2.

  PMID: 33389459 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Gabriel Mircescu, Prof

  Carol Davila University of Medicine and Pharmacy

  STUDY CHAIR

Central Study Contacts

Liliana Garneata, Assoc Prof

CONTACT

+40722619358; lilianagarna@yahoo.com

Gabriel Stefan, MD

CONTACT

+40724906188; gabriel_stefan@rocketmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 30, 2017
• First Posted: January 30, 2018
• Study Start: October 1, 2019
• Primary Completion: September 30, 2022
• Study Completion: March 31, 2023
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: March 2022

Locations

RO (1)