HyperphosphatemiaPhase 3SBR759NCT01069692
Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients
A Phase 3 study testing SBR759A in people with Hyperphosphatemia and Chronic Kidney Disease, run by Novartis at 9 sites in 2 countries.
Trial summary
This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia, Chronic Kidney Disease
- What is being tested?
- SBR759A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Feb 2010to Oct 2010
- Phase
- Phase 3
- 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 of age
- Stable maintenance of hemodialysis 3 times per week for 3 months or greater
- Controlled serum phosphate if under phosphate-binder therapy
- Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening
Who cannot join
- Patients who are on peritoneal dialysis
- Patients who have a transplant or parathyroidectomy scheduled during the study
- Clinically significant GI disorder
- Unstable medical condition other than Chronic Kidney Disease
- Patient is currently being treated with oral iron
- History of hemachromatosis, or ferritin > 1000 ng/mL
- Transferrin saturation > 60%
- Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Italy6 sites
Novartis Investigative Site
Brescia, 25123
Novartis Investigative Site
Lecco, 23900
Novartis Investigator Site
Lucca, 55100
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Pavia, 27100
Novartis Investigative Site
Siena, 53100
Belgium3 sites
Novartis Investigative Site
Jette, 1090
Novartis Investigative Site
Liège, 4000
Novartis Investigative Site
Roeselare, 8800
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo
This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Being tested
- SBR759A
- Keywords
- Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia, Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis
- Medical subject headings
- Hyperphosphatemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBR759ADrug
SBR759A 6g daily
SBR759ADrug
Placebo Comparator 0g daily
SBR759ADrug
SBR759A 3g daily
SBR759ADrug
9g daily
SBR759ADrug
12g daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Placebo Receives: Drug: SBR759A |
| Arm 3 | Experimental | Not described Receives: Drug: SBR759A |
| Arm 2 | Experimental | Not described Receives: Drug: SBR759A |
| arm 4 | Experimental | SBR759A Receives: Drug: SBR759A |
| arm 5 | Experimental | Not described Receives: Drug: SBR759A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment
Measured: 6 weeks
Secondary outcomes (3)
Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment
Measured: 6 weeks
Evaluate dose-dependent efficacy of SBR759
Measured: 6 weeks
Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 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 HyperphosphatemiaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069692
- Sponsor's protocol ID
- CSBR759A2304
- Other IDs
- 2008-006097-15, 2008
- Acronym
- SBR759
- Status last verified
- Jul 2011
- First submitted
- 15 Feb 2010
- Last updated
- 19 Dec 2020
- 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 40576086Fukagawa M, Kasuga H, Joseph D, Sawata H, Junge G, Moore A, Akiba T. Efficacy and safety of SBR759, a novel calcium-free, iron (III)-based phosphate binder, versus placebo in chronic kidney disease stage V Japanese patients on maintenance renal replacement therapy. Clin Exp Nephrol. 2014 Feb;18(1):135-43. doi: 10.1007/s10157-013-0815-7. Epub 2013 May 15.
PubMed 23670305
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo
- ClinicalTrials.gov ID
- NCT01069692
- Acronym / sponsor ID
- SBR759 / CSBR759A2304
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia, Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Oct 2010 (actual)
- First posted
- 17 Feb 2010 (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 compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: SBR759APlacebo |
| Arm 3 | Experimental | Drug: SBR759A |
| Arm 2 | Experimental | Drug: SBR759A |
| arm 4 | Experimental | Drug: SBR759ASBR759A |
| arm 5 | Experimental | Drug: SBR759A |
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 of age
- Stable maintenance of hemodialysis 3 times per week for 3 months or greater
- Controlled serum phosphate if under phosphate-binder therapy
- Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening
Key exclusion criteria (8 listed)
- Patients who are on peritoneal dialysis
- Patients who have a transplant or parathyroidectomy scheduled during the study
- Clinically significant GI disorder
- Unstable medical condition other than Chronic Kidney Disease
- Patient is currently being treated with oral iron
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 |
|---|---|---|
| SBR759ASBR759A 6g daily | Drug | Arm 3 |
| SBR759APlacebo Comparator 0g daily | Drug | Arm 1 |
| SBR759ASBR759A 3g daily | Drug | Arm 2 |
| SBR759A9g daily | Drug | arm 4 |
| SBR759A12g daily | Drug | arm 5 |
Primary outcome
Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment
Time frame: 6 weeks
3 secondary outcomes
Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment
Time frame: 6 weeks
Evaluate dose-dependent efficacy of SBR759
Time frame: 6 weeks
Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo
Time frame: 6 weeks
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 19 Dec 2020.
- 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 23670305Fukagawa M, Kasuga H, Joseph D, Sawata H, Junge G, Moore A, Akiba T. Efficacy and safety of SBR759, a novel calcium-free, iron (III)-based phosphate binder, versus placebo in chronic kidney disease stage V Japanese patients on maintenance renal replacement therapy. Clin Exp Nephrol. 2014 Feb;18(1):135-43. doi: 10.1007/s10157-013-0815-7. Epub 2013 May 15.
- Results for CSBR759A2304 from the Novartis Clinical Trials websiteLink 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.
Novartis Pharmceuticals study director
Novartis Pharmaceuticals
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SBR759A in people with Hyperphosphatemia and Chronic Kidney Disease, run by Novartis at 9 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 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Belgium. 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 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?
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?
Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment (time frame: 6 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 NCT01069692, 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 19 Dec 2020.