Chronic Kidney Disease, Stage 5Phase 3NCT00441545
Head to Head Study Against Sevelamer Hydrochloride
A Phase 3 study testing Fosrenol (Lanthanum Carbonate) and Sevelamer hydrochloride in people with Chronic Kidney Disease, Stage 5, run by Shire at 44 sites in 4 countries.
Trial summary
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Stage 5
- What is being tested?
- Fosrenol (Lanthanum Carbonate) and Sevelamer hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 44 sitesin 4 countries
- Study dates
- 5 Jan 2007to 31 Jul 2008
- Phase
- Phase 3
- 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
- Adults with end stage renal disease who are receiving dialysis
Who cannot join
- Subjects with significant gastrointestinal disorders
- Subjects who are pregnant or nursing
- Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride
- Subjects who are HIV positive
- Subjects with clinical significant liver disease
Trial locations and contacts
44 sites in 4 countries.
44 sites in 4 countries
United States34 sites
Alexandria Kidney
Alexandria, Virginia, 22304
Kidney Care Associates, LLC
Augusta, Georgia, 30901
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70809
Hypertension and Nephrology, Associates
Eatontown, New Jersey, 07724
South Valley Dialysis Center
Encino, California, 91316
Evanston Northwestern Hospital
Evanston, Illinois, 60201
Research by Design, LLC
Evergreen Park, Illinois, 60805
Clinical Research & Consulting Center, LLC
Fairfax, Virginia, 22030
Shands University of Florida Outpatient Dialysis
Gainesville, Florida, 32608
Carolina Nephrology, PA
Greenville, South Carolina, 29605
Clinical Research Connections
Jonesboro, Arkansas, 72401
VA Greater Los Angeles Health Care System, West LA
Los Angeles, California, 90073
Renal Physicians of Georgia
Macon, Georgia, 31217
DSI Renal Inc.
Mesa, Arizona, 85202
Winthrop Dialysis Center
Mineola, New York, 11501
Nephrology Inc.
Mishawaka, Indiana, 46545
VA Tennessee Valley Healthcare System
Nashville, Tennessee, 37212
Discovery Medical Research Group
Ocala, Florida, 34471
Creighton University Medical Center
Omaha, Nebraska, 68131
Pines Clinical Research
Pembroke Pines, Florida, 33028
AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85012
Northwest Renal Clinic
Portland, Oregon, 97210
Wake Nephrology Associates
Raleigh, North Carolina, 27609
Apex Research of Riverside
Riverside, California, 92505
Rosa Verde Tower
San Antonio, Texas, 78205
University of Texas Health Science Center at San Antonio Medicine/Nephrology
San Antonio, Texas, 78229
SUNY at Stony Brook NY
Stony Brook, New York, 11794
Southwest Kidney Institute, PLC
Tempe, Arizona, 85284
Study site
Tempe, Arizona, 85284
Western Nephrology & Metabolic Bone Disease, PC
Thornton, Colorado, 80260
University of Arizona Health Service Center
Tucson, Arizona, 85724
Clinical Research Center of Indian River Medical Center
Vero Beach, Florida
Southeastern Nephrology Associates
Wilmington, North Carolina, 28401
North Valley Nephrology
Yuba City, California, 95991
Germany8 sites
KfH Nierenzentrum/Bad/Konig
Bad König, 64732
KfH Nierenzentrum
Berlin, 10559
KfH Dialysezentrum/Berlin
Berlin, 12045
KfH Nierenzentrum/Dulmen
Dülmen, 48249
Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie
Göttingen, 37075
Dialysezentrum Barmbeck
Hamburg, 22297
KfH-Nierenzentrum/Jena
Jena, 07751
KfH-Dialysezentrum/Rosenheim
Rosenheim, 83022
United Kingdom1 site
Churchill Hospital Oxford Kidney Unit
Oxford, OX3 7LJ
About this study
Official title: A Prospective, Multicenter, Open-label, Randomized, Cross-over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
Read the detailed description
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
- Conditions
- Chronic Kidney Disease, Stage 5
- Being tested
- Fosrenol (Lanthanum Carbonate), Sevelamer hydrochloride
- 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.
Fosrenol (Lanthanum Carbonate)Drug
Also called FOSRENOL
The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
Sevelamer hydrochlorideDrug
The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fosrenol (Lanthanum carbonate) Receives: Drug: Fosrenol (Lanthanum Carbonate) |
| 2 | Active comparator | Sevelamer hydrochloride Receives: Drug: Sevelamer hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Serum Phosphorus Levels at 4 Weeks
Measured: 4 weeks
Secondary outcomes (3)
Change From Baseline in Serum Calcium Levels at 4 Weeks
Measured: 4 weeks
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
Measured: Baseline and 4 weeks
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study start5 Jan 2007
- Primary completion31 Jul 2008
- Study completion31 Jul 2008
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 Disease, Stage 5Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441545
- Sponsor's protocol ID
- SPD405-319
- Other IDs
- 2006-004959-38
- Status last verified
- Jun 2021
- First submitted
- 27 Feb 2007
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Sprague SM, Ross EA, Nath SD, Zhang P, Pratt RD, Krause R. Lanthanum carbonate vs. sevelamer hydrochloride for the reduction of serum phosphorus in hemodialysis patients: a crossover study. Clin Nephrol. 2009 Oct;72(4):252-8. doi: 10.5414/cnp72252.
PubMed 19825330Natale 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label, Randomized, Cross-over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT00441545
- Acronym / sponsor ID
- SPD405-319
- Conditions
- Chronic Kidney Disease, Stage 5
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2007 (actual)
- Primary completion
- 31 Jul 2008 (actual)
- Study completion
- 31 Jul 2008 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Posted 13 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
Detailed description
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fosrenol (Lanthanum Carbonate)Fosrenol (Lanthanum carbonate) |
| 2 | Active comparator | Drug: Sevelamer hydrochlorideSevelamer hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with end stage renal disease who are receiving dialysis
Key exclusion criteria (5 listed)
- Subjects with significant gastrointestinal disorders
- Subjects who are pregnant or nursing
- Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride
- Subjects who are HIV positive
- Subjects with clinical significant liver disease
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 |
|---|---|---|
| Fosrenol (Lanthanum Carbonate)Also: FOSRENOLThe starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets. | Drug | 1 |
| Sevelamer hydrochlorideThe starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals. | Drug | 2 |
Primary outcome
Change From Baseline in Serum Phosphorus Levels at 4 Weeks
Time frame: 4 weeks
3 secondary outcomes
Change From Baseline in Serum Calcium Levels at 4 Weeks
Time frame: 4 weeks
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
Time frame: Baseline and 4 weeks
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19825330Sprague SM, Ross EA, Nath SD, Zhang P, Pratt RD, Krause R. Lanthanum carbonate vs. sevelamer hydrochloride for the reduction of serum phosphorus in hemodialysis patients: a crossover study. Clin Nephrol. 2009 Oct;72(4):252-8. doi: 10.5414/cnp72252.
- 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.
- FDA recall informationLink provided by the sponsor.
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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
44 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fosrenol (Lanthanum Carbonate) and Sevelamer hydrochloride in people with Chronic Kidney Disease, Stage 5, run by Shire at 44 sites in 4 countries.
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 1 inclusion and 5 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 11 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 44 sites in United States, Germany, Puerto Rico, United Kingdom. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 Aug 2009). 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?
Change From Baseline in Serum Phosphorus Levels at 4 Weeks (time frame: 4 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 NCT00441545, 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 11 Jun 2021.