The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease

Metabolic Bone Disease Clinical Trial

Official title:

The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002872
• Other study ID #: EH 09-156
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: September 2023
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Kidney Diseases
• Metabolic Bone Disease
• Renal Insufficiency, Chronic

Intervention

Drug:
• Lanthanum Carbonate (Fosrenol)
Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill three times a day (TID) Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus <3.5mg/dL Reduce to 1 pill twice a day (BID). If Phosphorus >5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is <3.5mg/dL Reduce to 1 pill daily. If phosphorus >5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus <3.5mg/dL stop the drug If phosphorus is >5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner
• placebo
Initial dose of placebo will be 1 pill three times a day

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
NorthShore University HealthSystem	Shire

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline	Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days	Baseline, 60 days
Secondary	Calcium Mean Change From Baseline	Mean change from baseline Calcium level at 60 days	Baseline, 60 days
Secondary	Serum Phosphate Mean Change From Baseline	Mean change from baseline serum phosphate at 60 days	Baseline, 60 days
Secondary	Change From Baseline Serum Parathyroid Hormone	Change from baseline serum parathyroid hormone at 60 days	Baseline, 60 days
Secondary	1,25 Dihydroxyvitamin D 3 Mean Change From Baseline	Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days	Baseline, 60 days
Secondary	25 Hydroxyvitamin D Mean Change From Baseline	Mean change from baseline 25 hydroxyvitamin D at 60 days	Baseline, 60 days
Secondary	Serum Alkaline Phosphatase Mean Change From Baseline	Mean change from baseline serum alkaline phosphatase at 60 days	Baseline, 60 days
Secondary	Serum Osteocalcin Mean Change From Baseline	Mean change from baseline serum osteocalcin at 60 days	Baseline, 60 days
Secondary	24 Hour Urine Phosphate Mean Change From Baseline	Mean change from baseline 24 hour urine phosphate at 60 days	Baseline, 60 days