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

September 19, 2023 updated by: Stuart Sprague, NorthShore University HealthSystem

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lanthanum Carbonate (Fosrenol)
Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol)
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
Other Names:
  • Fosrenol
Placebo Comparator: Placebo
Subject will receive placebo
Drug: placebo
Initial dose of placebo will be 1 pill three times a day
Other Names:
  • sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline
Time Frame: Baseline, 60 days
Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days
Baseline, 60 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NorthShore University HealthSystem

Collaborators

Shire

Investigators

  • Principal Investigator: Stuart M Sprague, DO, Northshore University Healthsystem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimated)

October 28, 2009

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH 09-156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be compiled into a manuscript

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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