Status:
COMPLETED
Supplemented Low Protein Diet and Progression of CKD
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Collaborating Sponsors:
Fresenius Kabi
Conditions:
Stage 4 Chronic Kidney Disease
Eligibility:
All Genders
60-80 years
Phase:
NA
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 diabeti...
Detailed Description
Design. A multicenter, controlled, randomized, open label clinical trial was performed in patients with T2DM in CKD stage 3b-4 (GFR \<44 to \>15 mL/min/1.73 m2) treated in hospitals of the Mexican Soc...
Eligibility Criteria
Inclusion
- Patients with diabetic nephropathy in stage 4 chronic kidney disease
- Patients in pre-dialysis
- Patients with signed informed consent forms.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT03818568
Start Date
November 1 2017
End Date
February 1 2021
Last Update
August 12 2021
Active Locations (2)
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1
Unidad de Investigación Médica en Enfermedades Nefrológicas, Instituto Mexicano del Seguro Social
Mexico City, Mexico City, Mexico, 06722
2
Unidad de Investigacion Medica en Enfermedades Nefrologicas, Hospital de Especialidades Centro Medico Nacional Siglo XXI
Mexico City, Mexico, 06720