HyperphosphatemiaPhase 1NCT02965053
A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
A Phase 1 study testing EOS789 and Renvela in people with Hyperphosphatemia, run by Chugai Pharmaceutical at 1 site in United States.
Trial summary
This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- EOS789 and Renvela
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CKD and hyperphosphatemia must meet the following criteria for study entry:
- Age ≥18 years
- On thrice-weekly hemodialysis for at least 3 months prior to screening
- Not having changed dialysis prescription within 4 weeks prior to screening for dialyzer, calcium concentration in dialysate, or dry weight more than 1 kg
- Receiving stable doses of treatments affecting serum phosphorus for at least 4 weeks prior to screening and willing to discontinue these treatments
Who cannot join
- Patients with CKD and hyperphosphatemia who meet any of the following criteria will be excluded from study entry:
- Uncontrolled diabetes and/or hypertension in the opinion of the investigators
- Uncontrolled chronic constipation and/or diarrhea in the opinion of the investigators
- Hospitalization for cardiac disease in previous 3 months
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, 2-Period, Crossover, Study to Explore The Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789 and its combination with sevelamer carbonate are tested in Period 1 and Period 2 respectively.
- Conditions
- Hyperphosphatemia
- Being tested
- EOS789, Placebo, Renvela
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS789Drug
PlaceboDrug
RenvelaDrug
Also called Sevelamer carbonate
| Study group | Role | What they receive |
|---|---|---|
| Period 1 Arm 1 | Experimental | EOS789 Dose 1 in treatment sequence 1, Placebo in treatment sequence 2 Receives: Drug: EOS789; Drug: Placebo |
| Period 1 Arm 2 | Experimental | Placebo in treatment sequence 1, EOS789 Dose 1 in treatment sequence 2 Receives: Drug: EOS789; Drug: Placebo |
| Period 2 Arm 1 | Experimental | EOS789 Dose 2 in treatment sequence 1, EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 2 Receives: Drug: EOS789; Drug: Renvela |
| Period 2 Arm 2 | Experimental | EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 1, EOS789 Dose 2 in treatment sequence 2 Receives: Drug: EOS789; Drug: Renvela |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidences of adverse events
Incidences of adverse events
Measured: Up to Day 42 in each treatment sequence
Safety: Change from baseline in vital signs
Change from baseline in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate)
Measured: Up to Day 42 in each treatment sequence
Safety: Change from baseline in clinical laboratory tests
Change from baseline in clinical laboratory tests (hematology, biochemistry, coagulation)
Measured: Up to Day 42 in each treatment sequence
Safety: Change from baseline in 12 lead ECGs
Change from baseline in 12 lead ECGs
Measured: Up to Day 42 in each treatment sequence
Secondary outcomes (7)
Pharmacokinetics: Plasma concentration of EOS789
Measured: Day 4, 9, 10, 11 in the first treatment sequence in each period
Pharmacokinetics: Total exposure (area under the curve [AUC])
Measured: Day 10 in the first treatment sequence in each period
Pharmacokinetics: Maximum concentration (Cmax)
Measured: Day 10 in the first treatment sequence in each period
Pharmacokinetics: Time to reach Cmax (Tmax)
Measured: Day 10 in the first treatment sequence in each period
Pharmacokinetics: Removal ratio of EOS789 by hemodialysis at steady state
Measured: Day 9 in the first treatment sequence in each period
Pharmacodynamics: Intestinal fractional phosphorus absorption and accumulated fecal excretion of phosphorus
Measured: Days 11 to 13 in the first treatment sequence and second treatment sequence in each period
Efficacy: Change from baseline of serum phosphorus (P), Calcium (Ca), Ca x P, intact parathyroid hormone (PTH), and fibroblast growth factor (FGF23) at Day 13
Measured: Day 13 in the first treatment sequence and second treatment sequence in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Leader, Study director, Chugai Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965053
- Sponsor's protocol ID
- EOS103US
- Status last verified
- Sep 2018
- First submitted
- 11 Nov 2016
- Last updated
- 13 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, 2-Period, Crossover, Study to Explore The Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
- ClinicalTrials.gov ID
- NCT02965053
- Acronym / sponsor ID
- EOS103US
- Conditions
- Hyperphosphatemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 16 Nov 2016 (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 is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789 and its combination with sevelamer carbonate are tested in Period 1 and Period 2 respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Period 1 Arm 1 | Experimental | Drug: EOS789, Drug: PlaceboEOS789 Dose 1 in treatment sequence 1, Placebo in treatment sequence 2 |
| Period 1 Arm 2 | Experimental | Drug: EOS789, Drug: PlaceboPlacebo in treatment sequence 1, EOS789 Dose 1 in treatment sequence 2 |
| Period 2 Arm 1 | Experimental | Drug: EOS789, Drug: RenvelaEOS789 Dose 2 in treatment sequence 1, EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 2 |
| Period 2 Arm 2 | Experimental | Drug: EOS789, Drug: RenvelaEOS789 Dose 2 + Sevelamer carbonate in treatment sequence 1, EOS789 Dose 2 in treatment sequence 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with CKD and hyperphosphatemia must meet the following criteria for study entry:
- Age ≥18 years
- On thrice-weekly hemodialysis for at least 3 months prior to screening
- Not having changed dialysis prescription within 4 weeks prior to screening for dialyzer, calcium concentration in dialysate, or dry weight more than 1 kg
- Receiving stable doses of treatments affecting serum phosphorus for at least 4 weeks prior to screening and willing to discontinue these treatments
Key exclusion criteria (6 listed)
- Patients with CKD and hyperphosphatemia who meet any of the following criteria will be excluded from study entry:
- Uncontrolled diabetes and/or hypertension in the opinion of the investigators
- Uncontrolled chronic constipation and/or diarrhea in the opinion of the investigators
- Hospitalization for cardiac disease in previous 3 months
- Evidence of acute or chronic hepatitis or known liver cirrhosis
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 |
|---|---|---|
| EOS789 | Drug | Period 1 Arm 1, Period 1 Arm 2, Period 2 Arm 1, Period 2 Arm 2 |
| Placebo | Drug | Period 1 Arm 1, Period 1 Arm 2 |
| RenvelaAlso: Sevelamer carbonate | Drug | Period 2 Arm 1, Period 2 Arm 2 |
Primary outcome
Safety: Incidences of adverse events
Time frame: Up to Day 42 in each treatment sequence
Incidences of adverse events
Safety: Change from baseline in vital signs
Time frame: Up to Day 42 in each treatment sequence
Change from baseline in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate)
Safety: Change from baseline in clinical laboratory tests
Time frame: Up to Day 42 in each treatment sequence
Change from baseline in clinical laboratory tests (hematology, biochemistry, coagulation)
Safety: Change from baseline in 12 lead ECGs
Time frame: Up to Day 42 in each treatment sequence
Change from baseline in 12 lead ECGs
7 secondary outcomes
Pharmacokinetics: Plasma concentration of EOS789
Time frame: Day 4, 9, 10, 11 in the first treatment sequence in each period
Pharmacokinetics: Total exposure (area under the curve [AUC])
Time frame: Day 10 in the first treatment sequence in each period
Pharmacokinetics: Maximum concentration (Cmax)
Time frame: Day 10 in the first treatment sequence in each period
Pharmacokinetics: Time to reach Cmax (Tmax)
Time frame: Day 10 in the first treatment sequence in each period
Pharmacokinetics: Removal ratio of EOS789 by hemodialysis at steady state
Time frame: Day 9 in the first treatment sequence in each period
Pharmacodynamics: Intestinal fractional phosphorus absorption and accumulated fecal excretion of phosphorus
Time frame: Days 11 to 13 in the first treatment sequence and second treatment sequence in each period
Efficacy: Change from baseline of serum phosphorus (P), Calcium (Ca), Ca x P, intact parathyroid hormone (PTH), and fibroblast growth factor (FGF23) at Day 13
Time frame: Day 13 in the first treatment sequence and second treatment sequence in each period
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 13 Sep 2018.
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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.
Clinical Leader study director
Chugai Pharmaceutical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EOS789 and Renvela in people with Hyperphosphatemia, run by Chugai Pharmaceutical at 1 site 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 5 inclusion and 6 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Safety: Incidences of adverse events (time frame: Up to Day 42 in each treatment sequence). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2018.