HyperphosphatemiaPhase 2NCT00505037
A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
A Phase 2 study testing ASP1585 and Sevelamer hydrochloride in people with Hyperphosphatemia and Chronic Kidney Disease, run by Astellas Pharma Inc at 6 sites in Japan.
Trial summary
To evaluate the superiority to placebo, dose-responsibility and safety. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hyperphosphatemia, Chronic Kidney Disease
- What is being tested?
- ASP1585 and Sevelamer hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 6 sitesJapan
- Study dates
- Oct 2007to Sep 2008
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent
- Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent.
- Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents
Who cannot join
- History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion
- Continuous severe constipation/diarrhea.
- History of parathyroid intervention [parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.] within 1 year of the acquisition of informed consent
- Diet restriction such as fasting and/or excessive dieting
- Uncontrolled hypertension
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Study site
Chūbu
Study site
Chugoku
Study site
Kansai
Study site
Kanto
Study site
Kyushu
Study site
Shikoku
About this study
Official title: A Phase 2, Randomized, Double-blind-placebo-controlled and Open-label-Sevelamer Hydrochloride-controlled, Dose-ranging Study for ASP1585 in Patients With Chronic Kidney Disease(CKD) and Hyperphosphatemia on Hemodialysis
To evaluate the superiority to placebo, dose-responsibility and safety.
Read the detailed description
This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Being tested
- ASP1585, Placebo, Sevelamer hydrochloride
- Keywords
- ASP1585, Renal Dialysis, Chronic Kidney Disease, Hyperphosphatemia
- 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.
ASP1585Drug
Oral
PlaceboDrug
Oral
Sevelamer hydrochlorideDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASP1585 dose #1 | Experimental | Not described Receives: Drug: ASP1585 |
| ASP1585 dose #2 | Experimental | Not described Receives: Drug: ASP1585 |
| ASP1585 dose #3 | Experimental | Not described Receives: Drug: ASP1585 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Sevelamer hydrochloride | Active comparator | Not described Receives: Drug: Sevelamer hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum phosphorus
Measured: 4 weeks
Secondary outcomes (5)
Change in serum phosphorus level by time
Measured: Up to 4 weeks
Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time
Measured: 4 Weeks
Change in corrected serum Ca level
Measured: 4 weeks
Change in Ca×P
Measured: 4 weeks
Change in intact PTH
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 posted20 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionSep 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505037
- Sponsor's protocol ID
- 1585-CL-0002
- Status last verified
- Mar 2011
- First submitted
- 18 Jul 2007
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 40576086Akizawa T, Origasa H, Kameoka C, Kaneko Y, Kanoh H. Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study. Ther Apher Dial. 2014 Jun;18 Suppl 2:24-32. doi: 10.1111/1744-9987.12202.
PubMed 24975892
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind-placebo-controlled and Open-label-Sevelamer Hydrochloride-controlled, Dose-ranging Study for ASP1585 in Patients With Chronic Kidney Disease(CKD) and Hyperphosphatemia on Hemodialysis
- ClinicalTrials.gov ID
- NCT00505037
- Acronym / sponsor ID
- 1585-CL-0002
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Keywords
- ASP1585, Renal Dialysis, Chronic Kidney Disease, Hyperphosphatemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Jul 2007 (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.
To evaluate the superiority to placebo, dose-responsibility and safety.
Detailed description
This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ASP1585 dose #1 | Experimental | Drug: ASP1585 |
| ASP1585 dose #2 | Experimental | Drug: ASP1585 |
| ASP1585 dose #3 | Experimental | Drug: ASP1585 |
| Placebo | Placebo comparator | Drug: Placebo |
| Sevelamer hydrochloride | Active comparator | Drug: Sevelamer hydrochloride |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent
- Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent.
- Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents
Key exclusion criteria (5 listed)
- History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion
- Continuous severe constipation/diarrhea.
- History of parathyroid intervention [parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.] within 1 year of the acquisition of informed consent
- Diet restriction such as fasting and/or excessive dieting
- Uncontrolled hypertension
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 |
|---|---|---|
| ASP1585Oral | Drug | ASP1585 dose #1, ASP1585 dose #2, ASP1585 dose #3 |
| PlaceboOral | Drug | Placebo |
| Sevelamer hydrochlorideOral | Drug | Sevelamer hydrochloride |
Primary outcome
Change in serum phosphorus
Time frame: 4 weeks
5 secondary outcomes
Change in serum phosphorus level by time
Time frame: Up to 4 weeks
Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time
Time frame: 4 Weeks
Change in corrected serum Ca level
Time frame: 4 weeks
Change in Ca×P
Time frame: 4 weeks
Change in intact PTH
Time frame: 4 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 22 Mar 2011.
- 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 24975892Akizawa T, Origasa H, Kameoka C, Kaneko Y, Kanoh H. Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study. Ther Apher Dial. 2014 Jun;18 Suppl 2:24-32. doi: 10.1111/1744-9987.12202.
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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.
Use Central Contact study chair
Astellas Pharma Inc
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP1585 and Sevelamer hydrochloride in people with Hyperphosphatemia and Chronic Kidney Disease, run by Astellas Pharma Inc at 6 sites in Japan.
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 3 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 22 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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?
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?
Change in serum phosphorus (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 NCT00505037, 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 22 Mar 2011.