Chronic Kidney Disease MedDRA version: 12.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease
Conditions
Interventions
Trade Name: Fosrenol (Lanthanum Carbonate)
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: lanthanum (III) carbonate hydrate
CAS Number: 54451240
Other descriptive name: LANTHANUM CARBONATE
Sponsors
Shire Pharmaceutical Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female subjects =18 years old, who have been in the care of a physician for CKD for >2 months, and are not expected to begin dialysis for at least 6 months 2) Screening c-terminal FGF23 > 50RU/mL 3) Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the formula derived from the Modification of Diet in Renal Disease (MDRD) 4) Screening normal serum phosphate (0.808-1.55mmol/L) and endogenous 25-hydroxy Vitamin D levels >20ng/mL 5) Adequate protein diet (includes 2-3 portions of protein rich food per day). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Subjects who require Vitamin D supplementation, or compounds containing calcium, phosphate, aluminium or magnesium, subjects with acute renal failure, and subjects with rapidly progressing glomerulonephritis 2) Vegetarian diet 3) Known allergy to iodine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels;Secondary Objective: 1. To assess the effects of lanthanum carbonate treatment on serum intact parathyroid hormone (iPTH) and 1,25-dihydroxy Vitamin D. 2. To assess the urinary fractional excretion of phosphate following treatment with lanthanum carbonate. 3. To assess serum phosphate, serum total calcium, and calcium-phosphate product following treatment with lanthanum carbonate. 4. To monitor the safety and tolerability of lanthanum carbonate compared with placebo in Stage 3 Chronic Kidney Disease (CKD) subjects. ;Primary end point(s): Serum intact FGF23 level at week 12 | — |
Countries
France
Outcome results
None listed