Chronic Kidney Disease
Conditions
Interventions
Trade Name: RENVELA TABLETS
Product Name: Renvela
Pharmaceutical Form: Tablet
Sponsors
Mario Negri Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age > 18 years; - estimated GFR by simplified MDRD formula > 15 mL/min/1.73m2; - 24-h urinary protein excretion rate = 0.5 g/24hour; - no concomitant treatment with phosphate binders; - written informed consent 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - serum phosphate level 5.5 mg/dL; - serum PTH levels >250 pg/mL; - serum calcium level 10.5 mg/dL; - history of congestive heart failure, myocardial infarction, cerebrovascular accident within the last 6 months; - cancer and any severe systemic disease or clinical condition that may jeopardize data interpretation or completion of the study; - presence of, or predisposition to, intestinal or ileus obstruction or severe gastrointestinal motility disorder (like severe constipation); - previous major gastrointestinal surgery; - previous kidney transplantation; - previous parathyroidectomy; - concomitant treatment with antiacid and phosphate binders with aluminium, magnesium, calcium or lanthanum; - concomitant treatment for secondary hyperparathyroidism with calcitriol, paracalcitriol and calcimimetic agents; - pregnancy or breastfeeding; - childbearing potential without reliable contraceptive methods during the whole study period; - participation in any clinical trial using an investigational product or device during the 30 days preceding the first protocol visit; - alcohol or drug (excluding tobacco) abuse ; - inability to comply with the study procedures during the whole study period, legal incapacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of 3-month Sevelamer carbonate therapy compared to standard therapy on 24 h urinary protein excretion in patients with CKD and residual proteinuria despite optimized RAS inhibitor therapy;Primary end point(s): 24-h urinary protein excretion (mean of three measurements;Timepoint(s) of evaluation of this end point: At begin and at the end of two treatment periods and at recovery visit. ;Secondary Objective: To assess the effect of the study treatment on office blood pressure; GFR as assessed by iohexol plasma clearance; 24-h urinary phosphate, calcium, magnesium, urea, sodium and albumin excretion; phosphate, calcium, magnesium, urea, sodium and albumin fractional clearance; venous pH and base excess; serum levels of fibroblast growth factor (FGF) 23 (C terminal segment and the intact form) and other biomarkers of mineral metabolism including vitamin 25 OH D, 1-25 Vitamin D, calcium, phosphorous, intact parathyroid hormone (PTH), alkaline phosphatase (ALP); serum levels of markers of inflammation such as high sensitivity C Reactive Protein (hsCRP) and interleukin 6 (IL-6); serum lipids (total, HDL and LDL cholesterol and triglycerides); parameters of arterial stiffness such as pulse wave velocity (PWV) and augmentation index as assessed non invasively via applanation tonometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - office blood pressure; - GFR as assessed by iohexol plasma clearance; - 24-h urinary phosphate, calcium, magnesium, urea, sodium and albumin excretion; - phosphate, calcium, magnesium, urea, sodium and albumin fractional clearance; - venous pH and base excess; - serum levels of FGF 23 (C terminal segment and the intact form) and other biomarkers of mineral metabolism including vitamin 25 OH D, 1-25 Vitamin D, calcium, phosphorous, PTH, ALP; - serum levels of markers of inflammation such as hsCRP and IL-6; - serum lipids (total, HDL and LDL cholesterol and triglycerides); - parameters of arterial stiffness such as PWV and augmentation index as assessed non invasively via applanation tonometry. ;Timepoint(s) of evaluation of this end point: At each visit except during the run-in period. | — |
Countries
Italy
Contacts
Public ContactRegulatory Affairs Clinical Studies
Mario Negri Institute
Outcome results
None listed