Chronic Kidney DiseasePhase 1NCT02510274
Single and Multiple Dosing Study in Hemodialysis Patients With Hyperphosphatemia in Japan
A Phase 1 study testing ASP3325 in people with Chronic Kidney Disease and Hyperphosphatemia Undergoing Hemodialysis, run by Astellas Pharma Inc at 5 sites in Japan.
Trial summary
The objective of this study is to assess PK, safety and tolerability of a single oral dose of ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d. before or just after each meal Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Chronic Kidney Disease, Hyperphosphatemia Undergoing Hemodialysis
- What is being tested?
- ASP3325
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesJapan
- Study dates
- 12 May 2014to 4 Nov 2014
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who has received maintenance hemodialysis 3 times a week for at least 12 weeks (84 days) prior to the scheduled first day of the washout period.
- Subject who can receive morning dialysis from the start of the washout period to the end of follow-up period. (Part 2)
- Subject with pre-dialysis serum Pi level between ≥6.0 and <10.0 mg/dL and be confirmed increase in serum Pi of ≥1.5 mg/dL after the maximum dialysis interval at the washout period week 1 or 2. (Part 2)
- Subject who did not change the type or dose of any phosphate binder(s), any nutritional supplements or any other drugs with phosphorus reducing action for at least 4 weeks (28 days) prior to the scheduled first day of the washout period.
- Subject who did not receive calcimimetics (e.g., cinacalcet HCl) for at least 12 weeks (84 days) prior to the scheduled first day of the washout period.
- Subject taking native or active vitamin D (including vitamin D analogues), calcitonin agents or PTH agents must be on stable dose for at least 4 weeks (28 days) prior to the scheduled first day of the washout period.
Who cannot join
- Subject who has a history of severe gastrointestinal disorder, major gastrointestinal surgery, malabsorption considered influential on the absorption of the drug and nutrition in the gastrointestinal tract.
- Subject who has a history of parathyroid intervention (e.g., parathyroidectomy [PTx], percutaneous ethanol injection therapy [PEIT]).
- Subject whose dry weight loss >5% within 12 weeks (84 days) prior to the scheduled start day of the washout period.
- Confirmed serum intact PTH >1000 pg/mL at the start of the washout period (only applicable for Part 2).
- Subject whose last 3 measurement values at the separate day of pre-dialysis systolic/diastolic blood pressure before the scheduled start day of the washout period or during the washout period are all 180 mmHg or higher and 120 mmHg or higher.
- Subject who has severe congestive heart failure (i.e., NYHA cardiac function classification Class III or severer).
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- Subject who experienced a myocardial infarction or major surgery excluding vascular access surgery within 12 weeks (84 days) prior to the informed consent signing.
- Subject who has any of liver function tests (ALT, AST, T-Bil) out of range as indicated below at the screening (Part 1) or during the washout period, or patients with a complication of serious hepatic disease (e.g., acute and active chronic hepatitis, liver cirrhosis). AST: >2×ULN, ALT: >2×ULN, T-Bil: >1.25×ULN
- Subject with history or complication of malignant tumor (considered eligible if recurrence has not been observed for at least 5 years).
- Subject with history of serious drug hypersensitivity, such as anaphylactic shock.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Site: 4
Aichi
Site: 5
Aichi
Site: 1
Ibaraki
Site: 2
Ibaraki
Site: 3
Shizuoka
About this study
Official title: A Phase 1, Single and Multiple Dosing Study to Evaluate Pharmacokinetics and Pharmacodynamics of ASP3325 in Patients With Chronic Kidney Disease and Hyperphosphatemia Undergoing Hemodialysis
The objective of this study is to assess PK, safety and tolerability of a single oral dose of ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d. before or just after each meal
Read the detailed description
[Part 1] This part is an open-label, uncontrolled study to evaluate PK and safety with single dosing of ASP3325 in hemodialysis patients. After washout period of therapeutic medication for hyperphosphatemia, six subjects will receive single oral administration of ASP3325 (Tablet A) on a non-dialysis day (Day 1).
[Part 2] This part is a 2-arm, open-label, uncontrolled study to evaluate PD, PK and safety with dosing ASP3325 Tablet B t.i.d. before or just after each meal.
Eligible subjects at screening will be entered into the washout period for stopping their phosphate-binding treatment. 20 subjects with serum inorganic phosphorus (Pi) level between ≥6.0 and <10.0 mg/dL during the washout period (washout period week 1 or washout period week 2) will be randomized to each treatment group and ASP3325 will be administered for 2 weeks until Day 14.
- Being tested
- ASP3325
- Keywords
- Hyperphosphatemia, ASP3325, Chronic Kidney Disease, pharmacodynamics, pharmacokinetics
- 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.
ASP3325Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| Part1, ASP3325 Tablet A | Experimental | ASP3325 tablets A will be orally administered with 150 mL of water in fasting condition on non-dialysis day in Day 1 Receives: Drug: ASP3325 |
| Part2, ASP3325 Tablet B group 1 | Experimental | ASP3325 tablets B will be orally administered t.i.d. 30 minutes before each meal for 2 weeks Receives: Drug: ASP3325 |
| Part2, ASP3325 Tablet B group 2 | Experimental | ASP3325 tablets B will be orally administered t.i.d. 30 minutes just after each meal for 2 weeks Receives: Drug: ASP3325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by adverse events: Part 1
Measured: Up to Day 7
Safety assessed by adverse events: Part 2
Measured: Up to Day 22
Safety assessed by vital signs: Part 1
Vital signs include body temperature, blood pressure and pulse rate)
Measured: Up to Day 7
Safety assessed by vital signs: Part 2
Vital signs include body temperature, blood pressure and pulse rate)
Measured: Up to Day 22
Safety assessed by clinical laboratory test: Part 1
Clinical laboratory tests include hematology and biochemistry
Measured: Up to Day 7
Safety assessed by clinical laboratory test: Part 2
Clinical laboratory tests include hematology and biochemistry
Measured: Up to Day 22
Safety assessed by 12-Lead ECG: Part 1
ECG: electrocardiogram
Measured: Up to Day 7
Safety assessed by 12-Lead ECG: Part 2
ECG: electrocardiogram
Measured: Up to Day 22
Secondary outcomes (12)
Cmax of unchanged ASP3325
Cmax:maximum plasma concentration
Measured: Part 1 Before administration, Day 1, 2, 4, 5 and 7
tmax of unchanged ASP3325
tmax = time to reach maximum plasma concentration
Measured: Part 1 Before administration, Day 1, 2, 4, 5 and 7
AUClast of ASP3325
AUClast: Area under the Curve of plasma concentration during observation period in each observational day
Measured: Part 1 Before administration, Day 1, 2, 4, 5 and 7
AUCinf of ASP3325
AUCinf: Area under the Curve of plasma concentration
Measured: Part 1 Before administration, Day 1, 2, 4, 5 and 7
t1/2 of ASP3325
t1/2 = apparent terminal elimination half-life
Measured: Part 1 Before administration, Day 1, 2, 4, 5 and 7
Vz/F of ASP3325
Vz/F = apparent volume of distribution
Measured: Part 1 Before administration, Day 1, 2, 4, 5 and 7
CL/F of ASP3325
CL/F = oral clearance
Measured: Part 1 Before administration, Day 1, 2, 4, 5 and 7
Ctrough of ASP3325
Ctrough = observed trough concentration
Measured: Part 2 Before administration, Day 3, 5, 8, 10, 12, 15 and 22
Serum Pi of ASP3325
Serum Pi: serum phosphate concentration before dialysis
Measured: Part 2 Day -21, -14, and -7 in washout period, Day 1, 8, 15 and 22
Serum Calcium (adjusted for albumin)
Corrected value of Calcium (Ca) (mg/dL) = Observed value of Ca (mg/dL) + [4-albumin (g/dL)
Measured: Part 2 Day -21, -14, and -7 in washout period, Day 1, 8, 15 and 22
Serum concentration of intact PTH before dialysis
PTH = parathyroid hormone
Measured: Part 2 Day -21 in washout period, Day 1, 8, 15 and 22
Serum concentration of FGF23
FGF23 = fibroblast growth factor 23
Measured: Part 2 Day -21 in washout period, Day 1, 8, 15 and 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study start12 May 2014
- Primary completion4 Nov 2014
- Study completion4 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510274
- Sponsor's protocol ID
- 3325-CL-0003
- Status last verified
- Oct 2024
- First submitted
- 8 Jul 2015
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single and Multiple Dosing Study to Evaluate Pharmacokinetics and Pharmacodynamics of ASP3325 in Patients With Chronic Kidney Disease and Hyperphosphatemia Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT02510274
- Acronym / sponsor ID
- 3325-CL-0003
- Keywords
- Hyperphosphatemia, ASP3325, Chronic Kidney Disease, pharmacodynamics, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 12 May 2014 (actual)
- Primary completion
- 4 Nov 2014 (actual)
- Study completion
- 4 Nov 2014 (actual)
- First posted
- 29 Jul 2015 (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.
The objective of this study is to assess PK, safety and tolerability of a single oral dose of ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d. before or just after each meal
Detailed description
[Part 1] This part is an open-label, uncontrolled study to evaluate PK and safety with single dosing of ASP3325 in hemodialysis patients. After washout period of therapeutic medication for hyperphosphatemia, six subjects will receive single oral administration of ASP3325 (Tablet A) on a non-dialysis day (Day 1).
[Part 2] This part is a 2-arm, open-label, uncontrolled study to evaluate PD, PK and safety with dosing ASP3325 Tablet B t.i.d. before or just after each meal.
Eligible subjects at screening will be entered into the washout period for stopping their phosphate-binding treatment. 20 subjects with serum inorganic phosphorus (Pi) level between ≥6.0 and <10.0 mg/dL during the washout period (washout period week 1 or washout period week 2) will be randomized to each treatment group and ASP3325 will be administered for 2 weeks until Day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part1, ASP3325 Tablet A | Experimental | Drug: ASP3325ASP3325 tablets A will be orally administered with 150 mL of water in fasting condition on non-dialysis day in Day 1 |
| Part2, ASP3325 Tablet B group 1 | Experimental | Drug: ASP3325ASP3325 tablets B will be orally administered t.i.d. 30 minutes before each meal for 2 weeks |
| Part2, ASP3325 Tablet B group 2 | Experimental | Drug: ASP3325ASP3325 tablets B will be orally administered t.i.d. 30 minutes just after each meal for 2 weeks |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject who has received maintenance hemodialysis 3 times a week for at least 12 weeks (84 days) prior to the scheduled first day of the washout period.
- Subject who can receive morning dialysis from the start of the washout period to the end of follow-up period. (Part 2)
- Subject with pre-dialysis serum Pi level between ≥6.0 and <10.0 mg/dL and be confirmed increase in serum Pi of ≥1.5 mg/dL after the maximum dialysis interval at the washout period week 1 or 2. (Part 2)
- Subject who did not change the type or dose of any phosphate binder(s), any nutritional supplements or any other drugs with phosphorus reducing action for at least 4 weeks (28 days) prior to the scheduled first day of the washout period.
- Subject who did not receive calcimimetics (e.g., cinacalcet HCl) for at least 12 weeks (84 days) prior to the scheduled first day of the washout period.
Key exclusion criteria (10 listed)
- Subject who has a history of severe gastrointestinal disorder, major gastrointestinal surgery, malabsorption considered influential on the absorption of the drug and nutrition in the gastrointestinal tract.
- Subject who has a history of parathyroid intervention (e.g., parathyroidectomy [PTx], percutaneous ethanol injection therapy [PEIT]).
- Subject whose dry weight loss >5% within 12 weeks (84 days) prior to the scheduled start day of the washout period.
- Confirmed serum intact PTH >1000 pg/mL at the start of the washout period (only applicable for Part 2).
- Subject whose last 3 measurement values at the separate day of pre-dialysis systolic/diastolic blood pressure before the scheduled start day of the washout period or during the washout period are all 180 mmHg or higher and 120 mmHg or higher.
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 |
|---|---|---|
| ASP3325oral | Drug | Part1, ASP3325 Tablet A, Part2, ASP3325 Tablet B group 1, Part2, ASP3325 Tablet B group 2 |
Primary outcome
Safety assessed by adverse events: Part 1
Time frame: Up to Day 7
Safety assessed by adverse events: Part 2
Time frame: Up to Day 22
Safety assessed by vital signs: Part 1
Time frame: Up to Day 7
Vital signs include body temperature, blood pressure and pulse rate)
Safety assessed by vital signs: Part 2
Time frame: Up to Day 22
Vital signs include body temperature, blood pressure and pulse rate)
Safety assessed by clinical laboratory test: Part 1
Time frame: Up to Day 7
Clinical laboratory tests include hematology and biochemistry
Safety assessed by clinical laboratory test: Part 2
Time frame: Up to Day 22
Clinical laboratory tests include hematology and biochemistry
Safety assessed by 12-Lead ECG: Part 1
Time frame: Up to Day 7
ECG: electrocardiogram
Safety assessed by 12-Lead ECG: Part 2
Time frame: Up to Day 22
ECG: electrocardiogram
12 secondary outcomes
Cmax of unchanged ASP3325
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
tmax of unchanged ASP3325
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
AUClast of ASP3325
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
AUCinf of ASP3325
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
t1/2 of ASP3325
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
Vz/F of ASP3325
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
CL/F of ASP3325
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
Ctrough of ASP3325
Time frame: Part 2 Before administration, Day 3, 5, 8, 10, 12, 15 and 22
Serum Pi of ASP3325
Time frame: Part 2 Day -21, -14, and -7 in washout period, Day 1, 8, 15 and 22
Serum Calcium (adjusted for albumin)
Time frame: Part 2 Day -21, -14, and -7 in washout period, Day 1, 8, 15 and 22
Serum concentration of intact PTH before dialysis
Time frame: Part 2 Day -21 in washout period, Day 1, 8, 15 and 22
Serum concentration of FGF23
Time frame: Part 2 Day -21 in washout period, Day 1, 8, 15 and 22
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 5 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Director study director
Astellas Pharma Inc
5 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 ASP3325 in people with Chronic Kidney Disease and Hyperphosphatemia Undergoing Hemodialysis, run by Astellas Pharma Inc at 5 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 6 inclusion and 10 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 assessed by adverse events: Part 1 (time frame: Up to Day 7). The study lists 8 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 5 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.