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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01128179
• Date of registration: 20/05/2010
• Primary sponsor: Shire Development LLC
• Public title: Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD
• Scientific title: 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
• Date of first enrolment: November 2010
• Target sample size: 33
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01128179
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

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

1. =18 years old.

2. Male, or non-pregnant, non-lactating females who agree to comply with any applicable
contraceptive requirements of the protocol.

3. Been in the care of a physician for CKD for >2 months, and are not expected to begin
dialysis for at least 6 months.

4. Screening serum c-terminal FGF23 > 50.0RU/mL.

5. Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the
MDRD formula.

6. Normal serum phosphate (0.808-1.55mmol/L).

7. Endogenous 25-hydroxy Vitamin D levels >20ng/mL.

8. Adequate protein diet (includes 2-3 portions of protein-rich food per day).

9. An understanding, ability, and willingness to fully comply with study procedures and
restrictions.

10. Ability to provide written, signed, and dated (personally) informed consent to
participate in the study.

Exclusion Criteria

1. Vitamin D supplementation required.

2. Compounds containing calcium, phosphate, aluminium or magnesium required.

3. Acute renal failure.

4. Rapidly progressing glomerulonephritis.

5. Vegetarian diet.

6. Known allergy to iodine.

7. 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.

8. 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).

9. 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.

10. Life-threatening malignancy or current multiple myeloma.

11. Known to be Human Immunodeficiency Virus (HIV) positive.

12. History of poor compliance with diet or medication that in the Investigator's opinion
may interfere with adherence to the protocol.

13. History of alcohol or other substance abuse within 6 months prior to screening.

14. Subjects must not have used another investigational medicinal product or taken part
in a clinical trial within the last 30 days prior to enrolment.

15. Subjects who have previously been enrolled into this study and subsequently
withdrawn.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease

Intervention(s)

Drug: Lanthanum carbonate

Drug: Placebo

Primary Outcome(s)

FGF-23 Levels [Time Frame: 12 Weeks]

Secondary Outcome(s)

PTH, serum phosphorus, serum calcium levels and urinary fractional excretion of phosphate [Time Frame: 12 Weeks]

Secondary ID(s)

SPD405-703

Source(s) of Monetary Support

Please refer to primary and secondary sponsors