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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

Tracking Information
First Submitted Date  ICMJE June 7, 2018
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date July 26, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03818568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Comorbidities [ Time Frame: 2 years ]
    measure of frequency and number of comorbidities
  • Hospitalizations [ Time Frame: 2 years ]
    measure of number and length of hospitalizations
  • Mortality [ Time Frame: 2 years ]
    measure of incidence of mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketoanalogues and Stage 4 CKD
Official Title  ICMJE Restriction of Proteins in the Diet and Supplementation With Ketoanalogues to Prevent Disease Progression in Patients With Stage 4 Chronic Kidney Disease
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Stage 4 Chronic Kidney Disease
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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).
    Intervention: Dietary Supplement: ketoanalogues of essential amino acids
  • 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).
    Intervention: Dietary Supplement: ketoanalogues of essential amino acids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03818568
Other Study ID Numbers  ICMJE 2015-785-038
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jose Ramon Paniagua Sierra, Coordinación de Investigación en Salud, Mexico
Study Sponsor  ICMJE Coordinación de Investigación en Salud, Mexico
Collaborators  ICMJE Fresenius Kabi
Investigators  ICMJE Not Provided
PRS Account Coordinación de Investigación en Salud, Mexico
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP