Clinical trial NCT01002872: The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease
Official title: The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Bone Disease
Keywords: FGF23
CKD
Fosrenol
Hyperphosphatemia
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2009-10-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This is a double blind randomized placebo controlled pilot study. Subjects with Chronic Kidney Disease ( CKD) stages 3-5 who are not undergoing renal replacement therapy and have not been started on phosphate binders will be randomized to either lanthanum carbonate 1500 mg daily or placebo for a 60 day treatment period. Patient doses will be increased up to a maximum dose of 3000 mg if the serum phosphate is greater than 5.5 mg/dL.

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

Primary outcomes:
measure: Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline
timeFrame: Baseline, 60 days
Secondary outcomes:
measure: Calcium Mean Change From Baseline
timeFrame: Baseline, 60 days
measure: Serum Phosphate Mean Change From Baseline
timeFrame: Baseline, 60 days
measure: Change From Baseline Serum Parathyroid Hormone
timeFrame: Baseline, 60 days
measure: 1,25 Dihydroxyvitamin D 3 Mean Change From Baseline
timeFrame: Baseline, 60 days
measure: 25 Hydroxyvitamin D Mean Change From Baseline
timeFrame: Baseline, 60 days
measure: Serum Alkaline Phosphatase Mean Change From Baseline
timeFrame: Baseline, 60 days
measure: Serum Osteocalcin Mean Change From Baseline
timeFrame: Baseline, 60 days
measure: 24 Hour Urine Phosphate Mean Change From Baseline
timeFrame: Baseline, 60 days
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Stuart M Sprague, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stubbs JR, Quarles LD. Fibroblast growth factor 23: uremic toxin or innocent bystander in chronic kidney disease? Nephrol News Issues. 2009 May;23(6):33-4, 36-7.
citation: Saji F, Shiizaki K, Shimada S, Okada T, Kunimoto K, Sakaguchi T, Hatamura I, Shigematsu T. Regulation of fibroblast growth factor 23 production in bone in uremic rats. Nephron Physiol. 2009;111(4):p59-66. doi: 10.1159/000210389. Epub 2009 Apr 1.
citation: Ibrahim S, Rashed L. Serum fibroblast growth factor-23 levels in chronic haemodialysis patients. Int Urol Nephrol. 2009;41(1):163-9. doi: 10.1007/s11255-008-9466-0. Epub 2008 Oct 7.
citation: Moe SM, Chen NX, Seifert MF, Sinders RM, Duan D, Chen X, Liang Y, Radcliff JS, White KE, Gattone VH 2nd. A rat model of chronic kidney disease-mineral bone disorder. Kidney Int. 2009 Jan;75(2):176-84. doi: 10.1038/ki.2008.456. Epub 2008 Sep 17.
citation: Fliser D, Kollerits B, Neyer U, Ankerst DP, Lhotta K, Lingenhel A, Ritz E, Kronenberg F; MMKD Study Group; Kuen E, Konig P, Kraatz G, Mann JF, Muller GA, Kohler H, Riegler P. Fibroblast growth factor 23 (FGF23) predicts progression of chronic kidney disease: the Mild to Moderate Kidney Disease (MMKD) Study. J Am Soc Nephrol. 2007 Sep;18(9):2600-8. doi: 10.1681/ASN.2006080936. Epub 2007 Jul 26.
citation: Fukagawa M, Kazama JJ. FGF23: its role in renal bone disease. Pediatr Nephrol. 2006 Dec;21(12):1802-6. doi: 10.1007/s00467-006-0230-3. Epub 2006 Aug 24.