A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo controlled Study to Assess the Effect of Lanthanum Carbonate on intact FGF23 in Normo-phosphataemic Subjects with Stage 3 Chronic Kidney Disease

Phase 1

• Conditions: Chronic Kidney Disease; MedDRA version: 12.1Level: LLTClassification code 10064848Term: Chronic kidney disease

• Registration Number: EUCTR2009-016531-35-FR
• Lead Sponsor: Shire Pharmaceutical Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-29
• Study Completion: 2012-04-16
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

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

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.

Study & Design

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