Metabolic Bone DiseaseNCT01002872
The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease
A study testing Lanthanum Carbonate (Fosrenol) in people with Metabolic Bone Disease, run by Endeavor Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Bone Disease
- What is being tested?
- Lanthanum Carbonate (Fosrenol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: 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.
Read the 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
- Being tested
- Lanthanum Carbonate (Fosrenol), placebo
- Keywords
- FGF23, CKD, Fosrenol, Hyperphosphatemia
- Medical subject headings
- Bone Diseases, Metabolic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanthanum Carbonate (Fosrenol)Drug
Also called 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
placeboDrug
Also called sugar pill
Initial dose of placebo will be 1 pill three times a day
| Study group | Role | What they receive |
|---|---|---|
| Lanthanum Carbonate (Fosrenol) | Active comparator | Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Receives: Drug: Lanthanum Carbonate (Fosrenol) |
| Placebo | Placebo comparator | Subject will receive placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 60 days
Secondary outcomes (8)
Calcium Mean Change From Baseline
Mean change from baseline Calcium level at 60 days
Measured: Baseline, 60 days
Serum Phosphate Mean Change From Baseline
Mean change from baseline serum phosphate at 60 days
Measured: Baseline, 60 days
Change From Baseline Serum Parathyroid Hormone
Change from baseline serum parathyroid hormone at 60 days
Measured: Baseline, 60 days
1,25 Dihydroxyvitamin D 3 Mean Change From Baseline
Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days
Measured: Baseline, 60 days
25 Hydroxyvitamin D Mean Change From Baseline
Mean change from baseline 25 hydroxyvitamin D at 60 days
Measured: Baseline, 60 days
Serum Alkaline Phosphatase Mean Change From Baseline
Mean change from baseline serum alkaline phosphatase at 60 days
Measured: Baseline, 60 days
Serum Osteocalcin Mean Change From Baseline
Mean change from baseline serum osteocalcin at 60 days
Measured: Baseline, 60 days
24 Hour Urine Phosphate Mean Change From Baseline
Mean change from baseline 24 hour urine phosphate at 60 days
Measured: Baseline, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metabolic Bone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Stuart Sprague, Endeavor Health
- Investigators
- Stuart M Sprague, DO, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002872
- Sponsor's protocol ID
- EH 09-156
- Status last verified
- Sep 2023
- First submitted
- 27 Oct 2009
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be compiled into a manuscript
Publications
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.
PubMed 19534362Saji 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.
PubMed 19339809Ibrahim 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.
PubMed 18839328Moe 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.
PubMed 18800026Fliser 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.
PubMed 17656479Fukagawa 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.
PubMed 16932898
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01002872
- Acronym / sponsor ID
- EH 09-156
- Conditions
- Metabolic Bone Disease
- Keywords
- FGF23, CKD, Fosrenol, Hyperphosphatemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Oct 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lanthanum Carbonate (Fosrenol) | Active comparator | Drug: Lanthanum Carbonate (Fosrenol)Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) |
| Placebo | Placebo comparator | Drug: placeboSubject will receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lanthanum Carbonate (Fosrenol)Also: FosrenolRandomization 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 | Lanthanum Carbonate (Fosrenol) |
| placeboAlso: sugar pillInitial dose of placebo will be 1 pill three times a day | Drug | Placebo |
Primary outcome
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
8 secondary outcomes
Calcium Mean Change From Baseline
Time frame: Baseline, 60 days
Serum Phosphate Mean Change From Baseline
Time frame: Baseline, 60 days
Change From Baseline Serum Parathyroid Hormone
Time frame: Baseline, 60 days
1,25 Dihydroxyvitamin D 3 Mean Change From Baseline
Time frame: Baseline, 60 days
25 Hydroxyvitamin D Mean Change From Baseline
Time frame: Baseline, 60 days
Serum Alkaline Phosphatase Mean Change From Baseline
Time frame: Baseline, 60 days
Serum Osteocalcin Mean Change From Baseline
Time frame: Baseline, 60 days
24 Hour Urine Phosphate Mean Change From Baseline
Time frame: Baseline, 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19534362Stubbs 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.
- Background: PubMed 19339809Saji 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.
- Background: PubMed 18839328Ibrahim 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.
- Background: PubMed 18800026Moe 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.
- Background: PubMed 17656479Fliser 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.
- Background: PubMed 16932898Fukagawa 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.
- Individual participant dataSharing planned: Yes. Data will be compiled into a manuscript
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart M Sprague, DO principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lanthanum Carbonate (Fosrenol) in people with Metabolic Bone Disease, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline (time frame: Baseline, 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002872, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.