dietary nutritional counseling or phosphate binders in the early stages of chronic kidney disease: effects on FGF 23

INTERVENTION: Trade Name: RENVELA*FL 30CPR RIV 800MG Pharmaceutical Form: Coated tablet INN or Proposed INN: SEVELAMER CARBONATE CAS Number: 845273‐93‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800‐ CONDITION: chronic kidney failure ; MedDRA version: 14.1 Level: LLT Classification code 10013346 Term: Disorders of phosphorus metabolism System Organ Class: 10027433 ‐ Metabolism and nutrition disorders Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] PRIMARY OUTCOME: Main Objective: Differences in the variation in circulating levels of FGF‐23 (T0‐T8) in group A and group B Primary end point(s): Control Mineral Metabolism in the early stages of chronic renal failure Secondary Objective: Effects of administration of a chelating phosphorus or counseling on diet and nutritional levels of Vit D, PTH, inflammation, bicarbonatemia, Klotho.Relation between phosphorus content of the diet and levels of FGF‐23. Timepoint(s) of evaluation of this end point: 8 weeks SECONDARY OUTCOME: Secondary end point(s): effects of administration of a chelating phosphorus dietary‐nutritional counseling on FGF 23 levels Timepoint(s) of evaluation of this end point: 8 weeks INCLUSION CRITERIA: Patients with CKD stage 2 and 3 with phosphorus> 3.5 mg / dl. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14