dietary-nutritional advice or phosphorus-binding drugs in the early stages of chronic kidney disease

Conditions: chronic kidney failure
MedDRA version: 14.1Level: LLTClassification code 10013346Term: Disorders of phosphorus metabolismSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-005107-33-IT

Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Exclusion Criteria

Age <18 and> 80 years. Therapy with diphosphonates, calcitriol, corticosteroid therapy, nephrotic syndrome, chronic and acute inflammatory diseases. Psychiatric illness. Serum calcium> 10.5 mg / dl
Pregnancy or breast-feeding.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Differences in the variation in circulating levels of FGF-23 (T0-T8) in group A and group B;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.;Primary end point(s): Control Mineral Metabolism in the early stages of chronic renal failure;Timepoint(s) of evaluation of this end point: 8 weeks

Secondary Outcome Measures

Name	Time	Method
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