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

NCT02031224 | Completed Phase 4 DMC

• 1 other identifier: AWG13/2007
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Restricted protein diets; Nutritional status

Outcome Measures

Primary Outcomes (1)

• Primary composite endpoint

  Need for renal replacement therapy or an at least 50% reduction in the estimated glomerular filtration rate compared to randomization

  15 months after randomization

Secondary Outcomes (16)

• Secondary efficacy parameter

  months 3-15 after randomization

• Secondary outcome measure - nitrogen balance

  15 months after randomization

• Secondary efficacy parameter - mineral metabolism

  15 weeks after randomization

• Secondary efficacy parameter

  15 weeks after randomization

• Secondary efficacy parameter

  15 weeks after randomization

Other Outcomes (2)

• Compliance - protein intake

  18 months after enrolment

• Compliance - energy intake

  18 weeks after enrolment

Study Arms (2)

Keto-diet (KD)

EXPERIMENTAL

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

Low Protein Diet group (LPD)

ACTIVE COMPARATOR

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

Interventions

Conventional low protein diet BEHAVIORAL

Also known as: LPD, Hypoproteic diet

Low Protein Diet group (LPD)

Very low protein diet supplemented with Ketosteril DIETARY_SUPPLEMENT

Also known as: SVLPD, Keto-diet

Keto-diet (KD)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Anemia Working Group Romania: lead
• Dr Carol Davila Teaching Hospital of Nephrology Bucharest: collaborator

Study Sites (1)

"Dr Carol Davila" Teaching Hospital of Nephrology

Bucharest, 010731, Romania

Location

Related Publications (2)

• Mircescu G, Garneata L, Stancu SH, Capusa C. Effects of a supplemented hypoproteic diet in chronic kidney disease. J Ren Nutr. 2007 May;17(3):179-88. doi: 10.1053/j.jrn.2006.12.012.

  PMID: 17462550 RESULT

• Hahn D, Hodson EM, Fouque D. Low protein diets for non-diabetic adults with chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 29;10(10):CD001892. doi: 10.1002/14651858.CD001892.pub5.

  PMID: 33118160 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

ketosteril; Diet, Ketogenic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Gabriel Mircescu, Prof

  Carol Davila University of Medicine and Pharmacy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nephrology, MD, PhD

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: March 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

RO (1)