NCT01002872

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Bone Disease

Interventions

Type	Name	Description
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
DRUG	placebo	Initial dose of placebo will be 1 pill three times a day

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-05-01
• Completion: 2012-12-01
• First posted: 2009-10-28
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

1 site across 1 country: United States