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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005107-33-IT
Enrollment
Unknown
Registered
2012-03-07
Start date
2012-01-13
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Age 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Italy

Contacts

Public Contactprof. S.Mazzaferro

azienda universitaria policlinico umberto I roma

sandro.mazzaferro@uniroma1.it3358417818

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026