Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD

Inclusion criteria

Subjects meeting all of the criteria listed below may be included in the study:

• ≥18 years old.
• Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
• Been in the care of a physician for CKD for >2 months, and are not expected to begin dialysis for at least 6 months.
• Screening serum c-terminal FGF23 > 50.0RU/mL.
• Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.
• Normal serum phosphate (0.808-1.55mmol/L).
• Endogenous 25-hydroxy Vitamin D levels >20ng/mL.
• Adequate protein diet (includes 2-3 portions of protein-rich food per day).
• An understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Ability to provide written, signed, and dated (personally) informed consent to participate in the study.

Exclusion criteria

• Vitamin D supplementation required.
• Compounds containing calcium, phosphate, aluminium or magnesium required.
• Acute renal failure.
• Rapidly progressing glomerulonephritis.
• Vegetarian diet.
• Known allergy to iodine.
• Clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study.
• Cirrhosis or other clinically significant liver disease (aspartate transaminase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal or bilirubin >2 times the upper limit of normal).
• Past (treated within the last 5 years) or present GI disorders including uncontrolled peptic ulcer, Crohn's disease (or other conditions where the integrity of the GI tract may be compromised), malignancy, or GI bleed within the last 6 months.
• Life-threatening malignancy or current multiple myeloma.
• Known to be Human Immunodeficiency Virus (HIV) positive.
• History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol.
• History of alcohol or other substance abuse within 6 months prior to screening.
• Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment.
• Subjects who have previously been enrolled into this study and subsequently withdrawn.