Chronic Kidney DiseasePhase 2NCT01128179

Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD

A Phase 2 study testing Lanthanum carbonate in people with Chronic Kidney Disease, run by Shire at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Lanthanum carbonate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 1 siteFrance
Study dates: 6 Dec 2010to 16 Apr 2012
Phase: Phase 2
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

Subjects meeting all of the criteria listed below may be included in the study:
≥18 years old.
Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
Been in the care of a physician for CKD for >2 months, and are not expected to begin dialysis for at least 6 months.
Screening serum c-terminal FGF23 > 50.0RU/mL.
Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.

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Normal serum phosphate (0.808-1.55mmol/L).
Endogenous 25-hydroxy Vitamin D levels >20ng/mL.
Adequate protein diet (includes 2-3 portions of protein-rich food per day).
An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Ability to provide written, signed, and dated (personally) informed consent to participate in the study.

Who cannot join

Vitamin D supplementation required.
Compounds containing calcium, phosphate, aluminium or magnesium required.
Acute renal failure.
Rapidly progressing glomerulonephritis.
Vegetarian diet.
Known allergy to iodine.

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Clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study.
Cirrhosis or other clinically significant liver disease (aspartate transaminase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal or bilirubin >2 times the upper limit of normal).
Past (treated within the last 5 years) or present GI disorders including uncontrolled peptic ulcer, Crohn's disease (or other conditions where the integrity of the GI tract may be compromised), malignancy, or GI bleed within the last 6 months.
Life-threatening malignancy or current multiple myeloma.
Known to be Human Immunodeficiency Virus (HIV) positive.
History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol.
History of alcohol or other substance abuse within 6 months prior to screening.
Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment.
Subjects who have previously been enrolled into this study and subsequently withdrawn.

Trial locations and contacts

1 site in 1 country.

France1 site

Dr Pablo Urena Torres
Saint-Ouen, Paris, 93400

Other trials in France

About this study

Official title: A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo-controlled Study to Assess the Effect of Lanthanum Carbonate on Intact FGF23 in Normo-phosphataemic Subjects With Stage 3 Chronic Kidney Disease

To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.

Conditions: Chronic Kidney Disease
Being tested: Lanthanum carbonate, Placebo
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lanthanum carbonateDrug
Also called Fosrenol/Foznol
1000 mg in chewable tablets administered three times a day (for a total of 3000 mg/day) for 12 weeks
PlaceboDrug
Matching placebo chewable tablets administered 3 times a day for 12 weeks

Study groups in NCT01128179
Study group	Role	What they receive
Lanthanum carbonate	Experimental	Not described Receives: Drug: Lanthanum carbonate
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)
FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.
Measured: 12 Weeks

Secondary outcomes (6)

Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)
Measured: 12 Weeks
Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)
Measured: 12 weeks
Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)
Measured: 12 weeks
Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)
Measured: 12 weeks
Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)
Measured: 12 weeks
Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 201016 Apr 2012

First posted21 May 2010 (estimated)
Study start6 Dec 2010
Primary completion16 Apr 2012
Study completion16 Apr 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 (2)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01128179
Sponsor's protocol ID: SPD405-703
Other IDs: 2009-016531-35, 2009
Status last verified: May 2021
First submitted: 20 May 2010
Last updated: 9 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Urena-Torres P, Prie D, Keddad K, Preston P, Wilde P, Wan H, Copley JB. Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial. BMC Nephrol. 2014 May 5;15:71. doi: 10.1186/1471-2369-15-71.
PubMed 24885942
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo-controlled Study to Assess the Effect of Lanthanum Carbonate on Intact FGF23 in Normo-phosphataemic Subjects With Stage 3 Chronic Kidney Disease
ClinicalTrials.gov ID: NCT01128179
Acronym / sponsor ID: SPD405-703
Conditions: Chronic Kidney Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 6 Dec 2010 (actual)
Primary completion: 16 Apr 2012 (actual)
Study completion: 16 Apr 2012 (actual)
First posted: 21 May 2010 (estimated)
Results: Posted 22 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lanthanum carbonate	Experimental	Drug: Lanthanum carbonate
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

≥18 years old.
Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
Been in the care of a physician for CKD for >2 months, and are not expected to begin dialysis for at least 6 months.
Screening serum c-terminal FGF23 > 50.0RU/mL.
Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.

Key exclusion criteria (15 listed)

Vitamin D supplementation required.
Compounds containing calcium, phosphate, aluminium or magnesium required.
Acute renal failure.
Rapidly progressing glomerulonephritis.
Vegetarian diet.

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 carbonateAlso: Fosrenol/Foznol1000 mg in chewable tablets administered three times a day (for a total of 3000 mg/day) for 12 weeks	Drug	Lanthanum carbonate
PlaceboMatching placebo chewable tablets administered 3 times a day for 12 weeks	Drug	Placebo

Primary outcome

Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)
Time frame: 12 Weeks
FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.

6 secondary outcomes

Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)
Time frame: 12 Weeks
Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)
Time frame: 12 weeks
Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)
Time frame: 12 weeks
Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)
Time frame: 12 weeks
Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)
Time frame: 12 weeks
Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 22 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lanthanum Carbonate	23	21
Placebo	12	12

Primary outcome: Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)

Time frame: 12 Weeks. Least squares mean (Standard Error). Unit: pg/ml

Measure	Lanthanum Carbonate n = 17	Placebo n = 12
Value	4.0089 (0.0709)	4.1210 (0.0844)

Lanthanum Carbonate vs Placebo: Mean Difference (Final Values): -0.1121 (95% CI -0.3389 to 0.1146), p = 0.3186, ANCOVA

Population analysed: Per-protocol (PP) set are subjects who received at least 1 dose of investigational product and who had primary data assessment available from Week 2 or later and who did not have pre-defined major protocol deviations that could have affected the primary variable.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lanthanum Carbonate	2 of 23 (8.7%)	2 of 23 (8.7%)	Not reported
Placebo	0 of 12 (0%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24885942Urena-Torres P, Prie D, Keddad K, Preston P, Wilde P, Wan H, Copley JB. Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial. BMC Nephrol. 2014 May 5;15:71. doi: 10.1186/1471-2369-15-71.
Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

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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.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lanthanum carbonate in people with Chronic Kidney Disease, run by Shire at 1 site in France.

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 11 inclusion and 15 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 9 Jun 2021. 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 France. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2013). 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?

Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF) (time frame: 12 Weeks). 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 NCT01128179, which also lists 2 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 9 Jun 2021.