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Ketoanalogues and Stage 4 CKD

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ClinicalTrials.gov Identifier: NCT03818568
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
Jose Ramon Paniagua Sierra, Coordinación de Investigación en Salud, Mexico

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 will be 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.


Condition or disease Intervention/treatment Phase
Stage 4 Chronic Kidney Disease Dietary Supplement: ketoanalogues of essential amino acids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Restriction of Proteins in the Diet and Supplementation With Ketoanalogues to Prevent Disease Progression in Patients With Stage 4 Chronic Kidney Disease
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: ketoanalogues of essential amino acids
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
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).

Active Comparator: Control
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
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).




Primary Outcome Measures :
  1. glomerular filtration [ Time Frame: 2 years ]
    Speed of reduction in glomerular filtration measured by cysteine C clearance and the need for dialysis glomerular filtration <15 mL/min/1.73 m2)


Secondary Outcome Measures :
  1. Comorbidities [ Time Frame: 2 years ]
    measure of frequency and number of comorbidities

  2. Hospitalizations [ Time Frame: 2 years ]
    measure of number and length of hospitalizations

  3. Mortality [ Time Frame: 2 years ]
    measure of incidence of mortality



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818568


Locations
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Mexico
Unidad de Investigación Médica en Enfermedades Nefrológicas, Instituto Mexicano del Seguro Social Recruiting
Mexico City, DF, Mexico, 06722
Contact: Jose Ramon Paniagua, PhD    56276900 ext 21371    jramonpaniaguas@gmail.com   
Contact: Maria de Jesus Ventura-Garcia, MSc    56276900 ext 21371    maria.ventuga@gmail.com   
Principal Investigator: Ramon Paniagua, MD, PhD         
Sub-Investigator: Catarina Munguia-Miranda, MD         
Sub-Investigator: Maria de Jesus Ventura-Garcia, MSc         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Fresenius Kabi

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Responsible Party: Jose Ramon Paniagua Sierra, Chief investigator, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03818568     History of Changes
Other Study ID Numbers: 2015-785-038
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Ramon Paniagua Sierra, Coordinación de Investigación en Salud, Mexico:
chronic kidney disease
ketoanalogue
diabetes
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency