Chronic kidney disease and metabolic syndrome
Conditions
Interventions
Trade Name: Fosrenol
Pharmaceutical Form: Powder for oral solution in sachet
INN or Proposed INN: Fosrenol 750 mg Powder for oral solution in sachet
CAS Number: 54451-24-0
Current Sponsor code: V03A E
Sponsors
FIBICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have previously participated in the study entitled "Influence of phosphorus excretion on the progression of renal damage: Mechanisms and clinical studies" and belonging to the group formed by tertile 2 + 3, according to the ratio between urinary excretion of phosphorus and creatinine (P / Cr). 2. Subjects of both sexes with age range between 18 and 85 years. 3. Patients with metabolic syndrome, defined by the presence of three or more of the diagnostic criteria established in the Joint Interim Statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity (Alberti et al Circulation 2009; 120:.. 1640-1645): (1) high waist circumference (women ?88 cm, man ?102 cm) (2) elevated triglycerides (?150 mg / dL) or use of specific medication (3) reduced HDL (men =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. hyperphosphataemic defined as phosphorus concentration greater than 5 mg / dl. 2. Patients with clinical signs of congestive heart failure. 3. Active infections within 30 days prior to baseline. 4. Patients with systemic inflammatory disease. 5. HIV infection, Hepatitis C and Hepatitis B. 6. History of cancer within the previous five years. 7. Chronic liver disease. 8. immunosuppressive therapy. 9. Pregnant women, breastfeeding, or planning to become pregnant. 10. Addiction to drugs or alcohol in the investigator's opinion, may interfere with the fulfillment of study requirements. 11. Inability or unwillingness of the individual or legal guardian or representative to give written informed consent. 12. Changes 5% higher glomerular filtration regarding renal function available prior to inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate that decreased urinary excretion of phosphorus, by administration of a phosphate binder (lanthanum carbonate) reduces the progression of chronic kidney disease CKD patients diagnosed with stage 2-3 and metabolic syndrome.;Secondary Objective: Evaluate the effectiveness of decreased phosphorus excretion of: - Parameters of cardiovascular function: Endothelial function, pulse wave velocity. - Parameters related to the metabolic syndrome and inflammation. - Detection of predictive biomarkers of kidney damage. -parameters of mineral metabolism: PTH, FGF23, Klotho, Vit D (1,25 (OH) D, 25 (OH) D) serum calcium and phosphorus, urinary calcium excretion, urinary excretion of phosphorus. ? To assess the safety of medication research;Primary end point(s): GFR measured by creatinine clearance (formula MDR / CKD-EPI ml / min / 1.73m2);Timepoint(s) of evaluation of this end point: Every three months for 12 months and every 6 months for 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): cardiovascular function parameters: Endothelial function, pulse wave velocity. - Parameters related to the metabolic syndrome and inflammation. - Detection of predictive biomarkers of kidney damage. -parameters of mineral metabolism: PTH, FGF23, Klotho, Vit D (1,25 (OH) D, 25 (OH) D) serum calcium and phosphorus, urinary calcium excretion, urinary excretion of phosphorus.;Timepoint(s) of evaluation of this end point: GFR measured by creatinine clearance (formula MDR / CKD-EPI ml / min / 1.73m2) | — |
Countries
Spain
Contacts
Public ContactBlanca Quijano Ruíz
FIBICO
Outcome results
None listed