Clinical trial NCT01128179: Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.


Eligibility 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.

Primary outcomes:
measure: Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)
timeFrame: 12 Weeks
measure: Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)
timeFrame: 12 weeks
measure: Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)
timeFrame: 12 weeks
measure: Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)
timeFrame: 12 weeks
measure: Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)
timeFrame: 12 weeks
measure: Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Saint Ouen
country: France
facility: Dr Pablo Urena Torres
state: Paris
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Urena-Torres P, Prie D, Keddad K, Preston P, Wilde P, Wan H, Copley JB. Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial. BMC Nephrol. 2014 May 5;15:71. doi: 10.1186/1471-2369-15-71.