Chronic Kidney DiseasePhase 2SBR759NCT00704678
Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis
A Phase 2 study testing SBR759 and Sevelamer HCl in people with Chronic Kidney Disease, run by Novartis Pharmaceuticals at 15 sites in 2 countries.
Trial summary
This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis 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?
- SBR759 and Sevelamer HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Aug 2008to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Men or women of at least 18 years old or 20 years old in Japan.
- Stable maintenance of hemodialysis 3 times per week.
- Controlled serum phosphate if under phosphate-binder therapy.
- Serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation.
Who cannot join
- Peritoneal dialysis or a non-conventional hemodialysis technique .
- Parathyroidectomy or transplant scheduled during the study.
- Uncontrolled hyperparathyroidism
- History of hemochromatosis or ferritin > 800 µg/L.
- Clinically significant GI disorder
- Unstable medical condition other than Chronic Kidney Disease.
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- Treated with sevelamer HCl monotherapy or SBR759.
- Treated with oral iron.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Japan12 sites
Novartis Investigative Site
Hitachiomiya, Ibaraki
Novartis Investigative Site
Kasukabe, Saitama
Novartis Investigative Site
Kōriyama, Fukushima
Novartis Investigative Site
Midori, Gunma
Novartis Investigative Site
Moriya, Ibaraki
Novartis Investigative Site
Nagano, Nagano
Novartis Investigative Site
Okayama, Okayama-ken
Novartis Investigative Site
Sakai, Osaka
Novartis Investigative Site
Sashima-gun, Ibaraki
Novartis Investigative Site
Shizuoka, Shizuoka
Novartis Investigative Site
Takamatsu, Kagawa-ken
Novartis Investigative Site
Tsu, Mie-ken
Taiwan3 sites
Novartis Investigative Site
Changhua
Novartis Investigative Site
Kaoshiung
Novartis Investigative Site
Taipei
About this study
Official title: A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis
This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis
- Conditions
- Chronic Kidney Disease
- Being tested
- SBR759, Sevelamer HCl
- Keywords
- Chronic Kidney Disease, hemodialysis, hyperphosphatemia, Asian, patients
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBR759Drug
1g tid
Sevelamer HClDrug
1.6 g tid
Sevelamer HClDrug
1.5 g tid
Sevelamer HClDrug
0.8 g tid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1g bid Receives: Drug: SBR759 |
| 2 | Active comparator | 0.8 g tid Receives: Drug: Sevelamer HCl |
| 3 | Experimental | 1.5 g tid Receives: Drug: Sevelamer HCl |
| 4 | Active comparator | 1.6 g tid Receives: Drug: Sevelamer HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rates achieving target serum phosphate levels.
Measured: Week 12
Secondary outcomes (1)
Responder rates in target patients with serum calcium-phosphate levels.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704678
- Sponsor's protocol ID
- CSBR759A2202
- Acronym
- SBR759
- Status last verified
- Sep 2016
- First submitted
- 23 Jun 2008
- Last updated
- 23 Sep 2016
- Results posted
- No
Publications
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 40576086Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton). 2011 Nov;16(8):743-50. doi: 10.1111/j.1440-1797.2011.01509.x.
PubMed 21854503
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis
- ClinicalTrials.gov ID
- NCT00704678
- Acronym / sponsor ID
- SBR759 / CSBR759A2202
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, hemodialysis, hyperphosphatemia, Asian, patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2010 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SBR7591g bid |
| 2 | Active comparator | Drug: Sevelamer HCl0.8 g tid |
| 3 | Experimental | Drug: Sevelamer HCl1.5 g tid |
| 4 | Active comparator | Drug: Sevelamer HCl1.6 g tid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women of at least 18 years old or 20 years old in Japan.
- Stable maintenance of hemodialysis 3 times per week.
- Controlled serum phosphate if under phosphate-binder therapy.
- Serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation.
Key exclusion criteria (9 listed)
- Peritoneal dialysis or a non-conventional hemodialysis technique .
- Parathyroidectomy or transplant scheduled during the study.
- Uncontrolled hyperparathyroidism
- History of hemochromatosis or ferritin > 800 µg/L.
- Clinically 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 |
|---|---|---|
| SBR7591g tid | Drug | 1 |
| Sevelamer HCl1.6 g tid | Drug | 4 |
| Sevelamer HCl1.5 g tid | Drug | 3 |
| Sevelamer HCl0.8 g tid | Drug | 2 |
Primary outcome
Responder rates achieving target serum phosphate levels.
Time frame: Week 12
1 secondary outcome
Responder rates in target patients with serum calcium-phosphate levels.
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- 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.
- Derived from this study: PubMed 21854503Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton). 2011 Nov;16(8):743-50. doi: 10.1111/j.1440-1797.2011.01509.x.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBR759 and Sevelamer HCl in people with Chronic Kidney Disease, run by Novartis Pharmaceuticals at 15 sites in 2 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 4 inclusion and 9 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan, Taiwan. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Responder rates achieving target serum phosphate levels. (time frame: Week 12). 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 NCT00704678, 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 23 Sep 2016.