Phase 2
Completed N=35
Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD
Source: ClinicalTrials.gov NCT01128179 ↗Enrolled (actual)
35
Serious AEs
5.7%
Results posted
May 2013
Primary outcomePrimary: Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF) — 4.0089; 4.1210 pg/ml — p=0.3186
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF) |
4.0089; 4.1210 | 0.3186 |
| SECONDARY Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF) |
1.67; -4.87 | 0.2995 |
| SECONDARY Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF) |
-1.75; -6.86 | 0.3252 |
| SECONDARY Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF) |
-5.9; -2.2 | 0.1459 |
| SECONDARY Change From Baseline in Serum Phosphate Values at Week 12 (LOCF) |
0.0053; 0.0350 | 0.6134 |
| SECONDARY Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF) |
0.0242; -0.0052 | 0.5636 |
| SECONDARY Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF) |
0.0581; 0.0710 | 0.9220 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01128179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.