N/A
Completed N=19
The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease
Metabolic Bone Disease
Source: ClinicalTrials.gov NCT01002872 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline — -62.96; 9.08 RU/mL — p=0.037
Summary
The aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus binder drug) on c-terminal and on FGF23 levels in patients with Chronic Kidney Disease (CKD).
Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease and patient mortality.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline |
-62.96; 9.08 | 0.037 sig |
| SECONDARY Calcium Mean Change From Baseline |
0.15; 0.04 | 0.721 |
| SECONDARY Serum Phosphate Mean Change From Baseline |
0.18; 0.22 | 0.897 |
| SECONDARY Change From Baseline Serum Parathyroid Hormone |
-18.75; -33.25 | 0.743 |
| SECONDARY 1,25 Dihydroxyvitamin D 3 Mean Change From Baseline |
-1.25; -12.20 | 0.416 |
| SECONDARY 25 Hydroxyvitamin D Mean Change From Baseline |
0.43; 2.00 | 0.672 |
| SECONDARY Serum Alkaline Phosphatase Mean Change From Baseline |
-0.50; -0.40 | 0.955 |
| SECONDARY Serum Osteocalcin Mean Change From Baseline |
— | <0.05 sig |
| SECONDARY 24 Hour Urine Phosphate Mean Change From Baseline |
-148.6; 5.2 | 0.0066 sig |
Eligibility Criteria
Inclusion Criteria
- Males and non-pregnant females ages 18 years of age or older
- Estimated glomerular filtration rate (GFR) between 15-60 ml/min/1.73m
- Serum phosphate > 3.5 mg/dL
- Fibroblast growth factor 2 (FGF2) > 100 relative units per milliliter (RU/mL)
- Corrected serum calcium >8.0mg/dL
Exclusion Criteria
- Current use of a phosphate binder
- Corrected serum calcium <8.0mg/dL
- Current use of prescription-based vitamin D therapy
- Acute kidney injury in last 3 months
- Significant GI disorder
- History of allergic reaction or sensitivity to lanthanum carbonate
- History of non compliance with visits or medications that preclude study compliance in the opinion of the investigator
- Pregnant or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
Data sourced from ClinicalTrials.gov (NCT01002872). 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.