Supplemented Low Protein Diet and Progression of CKD

NCT03818568 | Completed

• 1 other identifier: 2015-785-038
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 2

Brief Summary

Investigators intend to analyze diets restricted in protein and supplemented with ketoanalogues of essential amino acids, to slow the progress of renal damage and improve nutritional status in diabetic patients over 60 years with stage 4 chronic kidney disease. Evey 2 months, evaluations were performed of renal function (creatinine clearance, serum cysteine, proteinuria) and nutritional status (subjective global evaluation,dominant had pressure strength, body composition by bioelectric impedance, serum transferrin, serum prealbumin and serum aminogram) for a follow-up period of 2 years.

Conditions

Stage 4 Chronic Kidney Disease

Keywords

chronic kidney disease; ketoanalogue; diabetes

Outcome Measures

Primary Outcomes (1)

• glomerular filtration

  Speed of reduction in glomerular filtration measured by cysteine C clearance and the need for dialysis glomerular filtration \<15 mL/min/1.73 m2)

  2 years

Secondary Outcomes (3)

• Comorbidities

  2 years

• Hospitalizations

  2 years

• Mortality

  2 years

Study Arms (2)

ketoanalogues of essential amino acids

EXPERIMENTAL

Patients will receive conventional treatment according to the institution's clinical guidelines, with moderate restriction of proteins 0.6 g protein/kg/day, as recommended to slow renal damage progression), plus ketoanalogues in the established dosage (1 tablet/5 kg weight divided into 3 doses per day).

Dietary Supplement: ketoanalogues of essential amino acids

Control

ACTIVE COMPARATOR

Patients will receive conventional treatment according to the institution's clinical guidelines, with moderate restriction of proteins 0.6 g protein/kg/day, as recommended to slow renal damage progression).

Dietary Supplement: ketoanalogues of essential amino acids

Interventions

ketoanalogues of essential amino acids DIETARY_SUPPLEMENT

Patients will receive conventional treatment according to the institution's clinical guidelines, with moderate restriction of proteins 0.6 g protein/kg/day, as recommended to slow renal damage progression), plus ketoanalogues in the established dosage (1 tablet/5 kg weight divided into 3 doses per day).

Control; ketoanalogues of essential amino acids

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diabetic nephropathy in stage 4 chronic kidney disease
• Patients in pre-dialysis
• Patients with signed informed consent forms.

You may not qualify if:

• Patients who have received Ketosteril previously
• Patients participating in other intervention studies
• Pregnant women
• Patients with background of renal transplant
• Patients with cancer, HIV, seropositive for hepatitis B or C or receiving immunosuppressors, hypercalcemia
• Intolerance of Ketosteril ingredients
• Hereditary disorders in amino acid metabolism

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Fresenius Kabi: collaborator

Study Sites (2)

Unidad de Investigación Médica en Enfermedades Nefrológicas, Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 06722, Mexico

Location

Unidad de Investigacion Medica en Enfermedades Nefrologicas, Hospital de Especialidades Centro Medico Nacional Siglo XXI

Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus

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; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ramon Paniagua, MD, PhD

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief investigator

Model Details: Design. A multicenter, controlled, randomized, open label clinical trial. Group were: Low Protein Diet (LPD) and LPD Supplemented with Ketoanalogs (LPD+KA). The follow-up period was 1 year. Inclusion criteria: Adult patients with Type 2 Diabetes Mellitus, either sex, in stage 3b-4 of CKD. Exclusion criteria: Previous treatment with KA, kidney transplantation, cancer, HIV-AIDS, hepatitis B or C, patients receiving immunosuppressors, hypercalcemia, intolerance to KA or disorders of amino acid metabolism. Intervention. In both groups diet composition was the same: Energy, 35 kcals/kg, Lipids 35% and, Carbohydrate 55-60% of the total energy intake, fiber 20-25 g, NaCl \~5 g, K 50-60, Phosphate 800-1000 mg. Protein intake was 0.6 g/kg/day. Patients in LPD+KA received KA (1 tablet/5 kg/day). Each tablet contains: Keto-analogs of Isoleucine, Leucine, Phenylalanine, and Valine; hydroxyl analog of Methionine, and aminoacids Lysine, Threonine, Tryptophan, Histidine, and Tyrosine.

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: January 28, 2019
• Study Start: November 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: February 1, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)