An open, phase II, clinical trial to evaluate the effectiveness of decreased intestinal absorption of phosphorus in the progression of renal disease in patients with metabolic syndrome

Phase 1

• Conditions: Chronic kidney disease and metabolic syndrome; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-000619-42-ES
• Lead Sponsor: FIBICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-03
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 99

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 <40 mg / dL, women <50 mg / dL) or use of specific medication
(4) impaired fasting glucose (?100 mg / dL) or use of antidiabetic medication
(5) hypertension (systolic blood pressure ?130 or diastolic ?85 mm Hg or respectively) or use of antihypertensive medication.
4. Glomerular filtration rate estimated by the formula CKD-EPI, between 30 and 90 ml / min / 1.73m2. (stages 2 and 3 of the classification of chronic kidney disease)
5. Patient able to understand the study procedures and granted their informed consent trial participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 99
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br> - Parameters of cardiovascular function: Endothelial function, pulse wave velocity.<br> - Parameters related to the metabolic syndrome and inflammation.<br> - Detection of predictive biomarkers of kidney damage.<br> -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.<br> ? 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 Outcome Measures

Name	Time	Method
Secondary end point(s): cardiovascular function parameters: Endothelial function, pulse wave velocity.<br> - Parameters related to the metabolic syndrome and inflammation.<br> - Detection of predictive biomarkers of kidney damage.<br> -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)