HyperphosphatemiaPhase 1NCT03305471
DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis
A Phase 1 study testing DS-2330b PIB, Sevelamer and DS-2330b Tablet in people with Hyperphosphatemia, run by Daiichi Sankyo at 4 sites in United States.
Trial summary
This three-part study will be performed with participants on chronic hemodialysis. Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bottle (PIB) or tablet formulations of DS2330b Part B will test the safety, tolerability, and effects on serum phosphate (Pi)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- DS-2330b PIB, Sevelamer and DS-2330b Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Aug 2017to 3 Jan 2019
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a body mass index (BMI) of 18 kg/m^2 to 40 kg/m^2 (inclusive)
- Is on prescribed maintenance hemodialysis (three times a week) for at least 3 months before Screening with adequacy demonstrated by a dialysis clearance within 3 months before the first dose of the investigational medicinal product
- Has permanent vascular access [arteriovenous (A-V) fistula or graft]
- Is willing to comply with protocol-specified methods for family planning
- For Parts B and C only:
- Has protocol-specified acceptable serum Pi levels at Screening and in serum Pi after up to 3 weeks of washout from all Pi binders
- Has protocol-specified acceptable serum Ca^2+ level and intact parathyroid hormone (iPTH) level at screening
Who cannot join
- Is employed by the clinic or the sponsor
- Has family relationship with another study participant
- Has any history, current condition, or drug use that per protocol or in the opinion of the investigator might compromise:
- safety of the participant or their children
- safety of study staff
- analysis of study results
Show all 9Show fewer
- For Parts B and C only:
- Is not able to take sevelamer carbonate
- Has had partial or total parathyroidectomy within the last six months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
DaVita Clinical Research
Lakewood, Colorado, 80228
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809
Prism Clinical Research
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1b Study, to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Repeated Doses of DS-2330b Alone and When Co-administered With Sevelamer in Patients on Chronic Hemodialysis
This three-part study will be performed with participants on chronic hemodialysis.
- Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bottle (PIB) or tablet formulations of DS2330b
- Part B will test the safety, tolerability, and effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b PIB when given alone and when given along with sevelamer carbonate three times a day
- Part C is optional, and will test the effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b tablets when given with sevelamer carbonate
After screening, participants should expect the study to last about 21 days for Part A, and 46 days for Parts B and C.
- Conditions
- Hyperphosphatemia
- Being tested
- DS-2330b PIB, Placebo, Sevelamer, DS-2330b Tablet
- Keywords
- Chronic hemodialysis, Investigational drug
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-2330b PIBDrug
DS-2330b as powder in bottle with stock solution (PIB)
PlaceboDrug
Placebo matching stock solution in bottle
SevelamerDrug
Also called Sevelamer carbonate
Sevelamer is a phosphate binder. It is used to decrease serum phosphate (Pi) level in people with chronic kidney disease who are on dialysis.
DS-2330b TabletDrug
DS-2330b as tablet formulation
| Study group | Role | What they receive |
|---|---|---|
| Part A: DS-2330b PIB, then Tablet | Experimental | On a non-dialysis day, participants are given a single 250 mg dose of DS-2330b PIB [Treatment A1] right after breakfast. At least 3 days will be allowed to let the first dose wash out. Then on a non-dialysis day the participants are given a single 250 mg dose of DS-2330b in tablet form [Treatment A2] right after breakfast. Receives: Drug: DS-2330b PIB; Drug: DS-2330b Tablet |
| Part A: DS-2330b Tablet, then PIB | Experimental | On a non-dialysis day, participants are given a single 250 mg dose of DS-2330b in tablet form [Treatment A2] right after breakfast. At least 3 days will be allowed to let the first dose wash out. Then on a non-dialysis day the participants are given a single 250 mg dose of DS-2330b PIB [Treatment A1] right after breakfast. Receives: Drug: DS-2330b PIB; Drug: DS-2330b Tablet |
| Part B: Placebo | Placebo comparator | Participants are given placebo three times daily [Treatment B1] Receives: Drug: Placebo |
| Part B: DS-2330b PIB | Experimental | Participants are given 400 mg of DS-2330b PIB three times daily [Treatment B2] Receives: Drug: DS-2330b PIB |
| Part B: DS-2330b PIB + Sevelamer | Experimental | Participants are given 400 mg of DS-2330b PIB along with 1.6 grams of sevelamer three times daily [Treatment B3] Receives: Drug: DS-2330b PIB; Drug: Sevelamer |
| Part B: Placebo + Sevelamer | Experimental | Participants are given placebo along with 1.6 grams of sevelamer three times daily [Treatment B4] Receives: Drug: Placebo; Drug: Sevelamer |
| Part C: DS-2330b Tablet + Sevelamer | Experimental | Participants are given one 250 mg dose of DS-2330b in tablet form along with 1.6 grams of sevelamer three times daily [Treatment C] Receives: Drug: Sevelamer; Drug: DS-2330b Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A, Period 1: Maximum concentration (Cmax) of DS-2330a
Measured: Period 1, Pre-dose to 48 hours post-dose
Part A, Period 2: Cmax of DS-2330a
Measured: Period 2, Pre-dose to 48 hours post-dose
Part A, Period 1: Time to maximum concentration (Tmax) of DS-2330a
Measured: Period 1, Pre-dose to 48 hours post-dose
Part A, Period 2: Tmax of DS-2330a
Measured: Period 2, Pre-dose to 48 hours post-dose
Part A, Period 1: Area under the drug concentration curve (AUC) for DS-2330a over 24 hours (AUC-24)
Measured: Period 1, Pre-dose to 24 hours post-dose
Part A, Period 2: AUC for DS-2330a for DS-2330a over 24 hours (AUC-24)
Measured: Period 2, Pre-dose to 24 hours post-dose
Part A, Period 1: AUC at the last observable concentration (AUClast) and to infinity (AUCinf) for DS-2330a
Categories (with the same unit of measure ng*hr/mL): AUClast, AUCinf
Measured: Period 1, Pre-dose to 48 hours post-dose
Part A, Period 2: AUClast and AUCinf for DS-2330a
Categories (with the same unit of measure ng*hr/mL): AUClast, AUCinf
Measured: Period 2, Pre-dose to 48 hours post-dose
Parts B and C: Serum phosphate (Pi) levels before hemodialysis
Measured: within 15 days
All Parts: Number of trial participants with treatment-emergent adverse events (TEAEs)
TEAEs are adverse events (side effects) associated with taking an investigational product, whether or not they were caused by the investigational product. Clinically significant changes in physical exam findings, vital signs, electrocardiograms, clinical lab tests and thyroid function are recorded as TEAEs.
Measured: through trial completion (about 15 months)
Secondary outcomes (10)
Parts B and C: Cmax of DS-2330a
Measured: within 24 hours on Day 1
Parts B and C: Cmax of DS-2330a
Measured: within 24 hours on Day 13
Parts B and C: Tmax of DS-2330a
Measured: within 24 hours, Day 1
Parts B and C: Tmax of DS-2330a
Measured: within 24 hours, Day 13
Parts B and C: AUC-24 for DS-2330a
Measured: Day 1
Parts B and C: AUC-24 for DS-2330a
Measured: Day 13
Parts B and C: AUCinf for DS-2330a
Measured: Day 1
Parts B and C: AUCinf for DS-2330a
Measured: Day 13
Parts B and C: Minimum concentration (Ctrough) of DS-2330a
Trough blood levels for DS-2330a will be collected before the morning dose (prior to breakfast)
Measured: within 11 days
Part B: Dialysis clearance of DS-2330a
Measured: on Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start17 Aug 2017
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A has a 2-period, open-label, randomized, 2-way crossover design with a single dose of Treatments A1 and A2 Part B participants are randomized with a 2:3:3:3 ratio to Treatment B1, B2, B3, and B4, respectively, using a double-blind, repeated dose, parallel design Part C is an optional, single-arm, open label, repeated dose design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305471
- Sponsor's protocol ID
- DS2330-A-U103
- Status last verified
- Mar 2019
- First submitted
- 4 Oct 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 40576086
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study, to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Repeated Doses of DS-2330b Alone and When Co-administered With Sevelamer in Patients on Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT03305471
- Acronym / sponsor ID
- DS2330-A-U103
- Conditions
- Hyperphosphatemia
- Keywords
- Chronic hemodialysis, Investigational drug
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 10 Oct 2017 (actual)
- 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 three-part study will be performed with participants on chronic hemodialysis.
- Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bottle (PIB) or tablet formulations of DS2330b
- Part B will test the safety, tolerability, and effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b PIB when given alone and when given along with sevelamer carbonate three times a day
- Part C is optional, and will test the effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b tablets when given with sevelamer carbonate
After screening, participants should expect the study to last about 21 days for Part A, and 46 days for Parts B and C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Part A has a 2-period, open-label, randomized, 2-way crossover design with a single dose of Treatments A1 and A2 Part B participants are randomized with a 2:3:3:3 ratio to Treatment B1, B2, B3, and B4, respectively, using a double-blind, repeated dose, parallel design Part C is an optional, single-arm, open label, repeated dose design
| Arm | Type | Receives |
|---|---|---|
| Part A: DS-2330b PIB, then Tablet | Experimental | Drug: DS-2330b PIB, Drug: DS-2330b TabletOn a non-dialysis day, participants are given a single 250 mg dose of DS-2330b PIB [Treatment A1] right after breakfast. At least 3 days will be allowed to let the first dose wash out. Then on a non-dialysis day the participants are given a single 250 mg dose of DS-2330b in tablet form [Treatment A2] right after breakfast. |
| Part A: DS-2330b Tablet, then PIB | Experimental | Drug: DS-2330b PIB, Drug: DS-2330b TabletOn a non-dialysis day, participants are given a single 250 mg dose of DS-2330b in tablet form [Treatment A2] right after breakfast. At least 3 days will be allowed to let the first dose wash out. Then on a non-dialysis day the participants are given a single 250 mg dose of DS-2330b PIB [Treatment A1] right after breakfast. |
| Part B: Placebo | Placebo comparator | Drug: PlaceboParticipants are given placebo three times daily [Treatment B1] |
| Part B: DS-2330b PIB | Experimental | Drug: DS-2330b PIBParticipants are given 400 mg of DS-2330b PIB three times daily [Treatment B2] |
| Part B: DS-2330b PIB + Sevelamer | Experimental | Drug: DS-2330b PIB, Drug: SevelamerParticipants are given 400 mg of DS-2330b PIB along with 1.6 grams of sevelamer three times daily [Treatment B3] |
| Part B: Placebo + Sevelamer | Experimental | Drug: Placebo, Drug: SevelamerParticipants are given placebo along with 1.6 grams of sevelamer three times daily [Treatment B4] |
| Part C: DS-2330b Tablet + Sevelamer | Experimental | Drug: Sevelamer, Drug: DS-2330b TabletParticipants are given one 250 mg dose of DS-2330b in tablet form along with 1.6 grams of sevelamer three times daily [Treatment C] |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a body mass index (BMI) of 18 kg/m^2 to 40 kg/m^2 (inclusive)
- Is on prescribed maintenance hemodialysis (three times a week) for at least 3 months before Screening with adequacy demonstrated by a dialysis clearance within 3 months before the first dose of the investigational medicinal product
- Has permanent vascular access [arteriovenous (A-V) fistula or graft]
- Is willing to comply with protocol-specified methods for family planning
- For Parts B and C only:
Key exclusion criteria (9 listed)
- Is employed by the clinic or the sponsor
- Has family relationship with another study participant
- Has any history, current condition, or drug use that per protocol or in the opinion of the investigator might compromise:
- For Parts B and C only:
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 |
|---|---|---|
| DS-2330b PIBDS-2330b as powder in bottle with stock solution (PIB) | Drug | Part A: DS-2330b PIB, then Tablet, Part A: DS-2330b Tablet, then PIB, Part B: DS-2330b PIB, Part B: DS-2330b PIB + Sevelamer |
| PlaceboPlacebo matching stock solution in bottle | Drug | Part B: Placebo, Part B: Placebo + Sevelamer |
| SevelamerAlso: Sevelamer carbonateSevelamer is a phosphate binder. It is used to decrease serum phosphate (Pi) level in people with chronic kidney disease who are on dialysis. | Drug | Part B: DS-2330b PIB + Sevelamer, Part B: Placebo + Sevelamer, Part C: DS-2330b Tablet + Sevelamer |
| DS-2330b TabletDS-2330b as tablet formulation | Drug | Part A: DS-2330b PIB, then Tablet, Part A: DS-2330b Tablet, then PIB, Part C: DS-2330b Tablet + Sevelamer |
Primary outcome
Part A, Period 1: Maximum concentration (Cmax) of DS-2330a
Time frame: Period 1, Pre-dose to 48 hours post-dose
Part A, Period 2: Cmax of DS-2330a
Time frame: Period 2, Pre-dose to 48 hours post-dose
Part A, Period 1: Time to maximum concentration (Tmax) of DS-2330a
Time frame: Period 1, Pre-dose to 48 hours post-dose
Part A, Period 2: Tmax of DS-2330a
Time frame: Period 2, Pre-dose to 48 hours post-dose
Part A, Period 1: Area under the drug concentration curve (AUC) for DS-2330a over 24 hours (AUC-24)
Time frame: Period 1, Pre-dose to 24 hours post-dose
Part A, Period 2: AUC for DS-2330a for DS-2330a over 24 hours (AUC-24)
Time frame: Period 2, Pre-dose to 24 hours post-dose
Part A, Period 1: AUC at the last observable concentration (AUClast) and to infinity (AUCinf) for DS-2330a
Time frame: Period 1, Pre-dose to 48 hours post-dose
Categories (with the same unit of measure ng*hr/mL): AUClast, AUCinf
Part A, Period 2: AUClast and AUCinf for DS-2330a
Time frame: Period 2, Pre-dose to 48 hours post-dose
Categories (with the same unit of measure ng*hr/mL): AUClast, AUCinf
Parts B and C: Serum phosphate (Pi) levels before hemodialysis
Time frame: within 15 days
All Parts: Number of trial participants with treatment-emergent adverse events (TEAEs)
Time frame: through trial completion (about 15 months)
TEAEs are adverse events (side effects) associated with taking an investigational product, whether or not they were caused by the investigational product. Clinically significant changes in physical exam findings, vital signs, electrocardiograms, clinical lab tests and thyroid function are recorded as TEAEs.
10 secondary outcomes
Parts B and C: Cmax of DS-2330a
Time frame: within 24 hours on Day 1
Parts B and C: Cmax of DS-2330a
Time frame: within 24 hours on Day 13
Parts B and C: Tmax of DS-2330a
Time frame: within 24 hours, Day 1
Parts B and C: Tmax of DS-2330a
Time frame: within 24 hours, Day 13
Parts B and C: AUC-24 for DS-2330a
Time frame: Day 1
Parts B and C: AUC-24 for DS-2330a
Time frame: Day 13
Parts B and C: AUCinf for DS-2330a
Time frame: Day 1
Parts B and C: AUCinf for DS-2330a
Time frame: Day 13
Parts B and C: Minimum concentration (Ctrough) of DS-2330a
Time frame: within 11 days
Part B: Dialysis clearance of DS-2330a
Time frame: on Day 11
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 25 Mar 2019.
- 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.
Global Clinical Leader study director
Daiichi Sankyo
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DS-2330b PIB, Sevelamer and DS-2330b Tablet in people with Hyperphosphatemia, run by Daiichi Sankyo at 4 sites in United States.
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 7 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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Part A, Period 1: Maximum concentration (Cmax) of DS-2330a (time frame: Period 1, Pre-dose to 48 hours post-dose). The study lists 10 primary outcomes in all. 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 NCT03305471, which also lists 1 linked publication.
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 25 Mar 2019.