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

Primary Purpose

Metabolic Bone Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lanthanum Carbonate (Fosrenol)
placebo
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Bone Disease focused on measuring FGF23, CKD, Fosrenol, Hyperphosphatemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and non-pregnant females ages 18 years of age or older
  • Estimated GFR between 15-60 ml/min/1.73m
  • Serum phosphate > 3.5 mg/dL
  • FGF2 > 100RU/mL
  • Corrected serum clacium >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

Sites / Locations

  • NorthShore University HealthSystem

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lanthanum Carbonate (Fosrenol)

Placebo

Arm Description

Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol)

Subject will receive placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Calcium Mean Change From Baseline
Mean change from baseline Calcium level at 60 days
Serum Phosphate Mean Change From Baseline
Mean change from baseline serum phosphate at 60 days
Change From Baseline Serum Parathyroid Hormone
Change from baseline serum parathyroid hormone at 60 days
1,25 Dihydroxyvitamin D 3 Mean Change From Baseline
Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days
25 Hydroxyvitamin D Mean Change From Baseline
Mean change from baseline 25 hydroxyvitamin D at 60 days
Serum Alkaline Phosphatase Mean Change From Baseline
Mean change from baseline serum alkaline phosphatase at 60 days
Serum Osteocalcin Mean Change From Baseline
Mean change from baseline serum osteocalcin at 60 days
24 Hour Urine Phosphate Mean Change From Baseline
Mean change from baseline 24 hour urine phosphate at 60 days

Full Information

First Posted
October 27, 2009
Last Updated
September 19, 2023
Sponsor
NorthShore University HealthSystem
Collaborators
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01002872
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Bone Disease
Keywords
FGF23, CKD, Fosrenol, Hyperphosphatemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lanthanum Carbonate (Fosrenol)
Arm Type
Active Comparator
Arm Description
Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subject will receive placebo
Intervention Type
Drug
Intervention Name(s)
Lanthanum Carbonate (Fosrenol)
Other Intervention Name(s)
Fosrenol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pill
Intervention Description
Initial dose of placebo will be 1 pill three times a day
Primary Outcome Measure Information:
Title
Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline
Description
Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days
Time Frame
Baseline, 60 days
Secondary Outcome Measure Information:
Title
Calcium Mean Change From Baseline
Description
Mean change from baseline Calcium level at 60 days
Time Frame
Baseline, 60 days
Title
Serum Phosphate Mean Change From Baseline
Description
Mean change from baseline serum phosphate at 60 days
Time Frame
Baseline, 60 days
Title
Change From Baseline Serum Parathyroid Hormone
Description
Change from baseline serum parathyroid hormone at 60 days
Time Frame
Baseline, 60 days
Title
1,25 Dihydroxyvitamin D 3 Mean Change From Baseline
Description
Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days
Time Frame
Baseline, 60 days
Title
25 Hydroxyvitamin D Mean Change From Baseline
Description
Mean change from baseline 25 hydroxyvitamin D at 60 days
Time Frame
Baseline, 60 days
Title
Serum Alkaline Phosphatase Mean Change From Baseline
Description
Mean change from baseline serum alkaline phosphatase at 60 days
Time Frame
Baseline, 60 days
Title
Serum Osteocalcin Mean Change From Baseline
Description
Mean change from baseline serum osteocalcin at 60 days
Time Frame
Baseline, 60 days
Title
24 Hour Urine Phosphate Mean Change From Baseline
Description
Mean change from baseline 24 hour urine phosphate at 60 days
Time Frame
Baseline, 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart M Sprague, DO
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be compiled into a manuscript
Citations:
PubMed Identifier
19534362
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.
Results Reference
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PubMed Identifier
19339809
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.
Results Reference
background
PubMed Identifier
18839328
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.
Results Reference
background
PubMed Identifier
18800026
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.
Results Reference
background
PubMed Identifier
17656479
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.
Results Reference
background
PubMed Identifier
16932898
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.
Results Reference
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The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease

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