Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis TherapyPhase 1NCT01872026
Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis
A Phase 1 study testing ASP7991 in people with Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy and Pharmacodynamics of ASP7991, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after oral administration to patients with chronic kidney disease undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy, Pharmacodynamics of ASP7991, Pharmacokinetics of ASP7991
- What is being tested?
- ASP7991
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteJapan
- Study dates
- 26 Dec 2012to 26 Jun 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week for more than 12 weeks (84 days) and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period
- Patients who have secondary hyperparathyroidism;
- Receiving Active vitamin D or Cinacalcet hydrochloride
- OR iPTH values ≥ 180 pg/mL at screening in case patients receive no medication for secondary hyperparathyroidism.
- Corrected serum Ca at screening：≥ 8.4 mg/dL
- No changes in items below at least 7 days before screening and do not have a plan to change something in the items below during the trial.
- Dose and type of Active Vitamin D, Calcitonin preparation, Phosphate binder.
- Ca concentration of the dialysate, membrane area of the dialyzer and dialysis time of each week(possible to change within ±10%)
Who cannot join
- Patients who underwent parathyroid intervention within 24 weeks prior to the informed consent
- Patients who have primary hyperparathyroidism
- Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract
- Patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 120 mmHg are showed at the previous three points at the initiation of dialysis including the screening assessment)
- Complicated by severe heart disorder [congestive cardiac failure (NYHA classification III or higher), or wide range of old myocardial infarction], or having a history of hospitalization for cerebro-vascular disease or heart disorder within 12 weeks(84 days) before obtaining the informed consent.
- Concurrent serious hepatic disease (acute and active chronic hepatitis, hepatic cirrhosis)
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- History of malignant tumor
- History of serious drug allergy including anaphylactic shock
- Potentially child-bearing, lactating, those who do not comply with the instructed contraceptive measures
- Patients who were involved in an assessment of other clinical trial within 12 weeks(84 days) prior to the informed consent
- Patients who is an employee of the sponsor, CRO, SMO, or sites related to the study.
- Patients who have been judged ineligible to participate in the study by the investigator / sub investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASP7991 Clinical Pharmacological Study -Examination of Pharmacokinetics and Pharmacodynamics in Chronic Kidney Disease Patients Undergoing Hemodialysis
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after oral administration to patients with chronic kidney disease undergoing hemodialysis.
Read the detailed description
To examine the pharmacokinetics, pharmacodynamics and safety in patients with chronic kidney disease undergoing hemodialysis.
- To assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and the effect of hemodialysis on PK of single oral administration of ASP7991 in Part 1.
- To assess the safety, PK and PD of repeated oral administration of ASP7991 in part 2.
- Conditions
- Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy, Pharmacodynamics of ASP7991, Pharmacokinetics of ASP7991
- Being tested
- ASP7991
- Keywords
- ASP7991, Plasma concentration, Pharmacodynamics, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP7991Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1- single administration | Experimental | The lowest, middle and the highest dose ASP7991 as a single oral administration on non-dialysis day in step 1 to 3 and the highest dose on day of dialysis in step 4. Receives: Drug: ASP7991 |
| Part 2- repeated administration | Experimental | The lowest, middle and the highest dose ASP7991 as repeated oral administration in step 1 to 3. Receives: Drug: ASP7991 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and ophthalmic examination
Measured: For 9-16 days after dosing
Secondary outcomes (2)
Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F
Measured: For 9-16 days after dosing
iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P
Measured: For 9-16 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study start26 Dec 2012
- Primary completion26 Jun 2013
- Study completion26 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis TherapyStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT01872026
- Sponsor's protocol ID
- 7991-CL-1003
- Status last verified
- Oct 2024
- First submitted
- 5 Jun 2013
- Last updated
- 6 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 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP7991 Clinical Pharmacological Study -Examination of Pharmacokinetics and Pharmacodynamics in Chronic Kidney Disease Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT01872026
- Acronym / sponsor ID
- 7991-CL-1003
- Conditions
- Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy, Pharmacodynamics of ASP7991, Pharmacokinetics of ASP7991
- Keywords
- ASP7991, Plasma concentration, Pharmacodynamics, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2012 (actual)
- Primary completion
- 26 Jun 2013 (actual)
- Study completion
- 26 Jun 2013 (actual)
- First posted
- 7 Jun 2013 (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 to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after oral administration to patients with chronic kidney disease undergoing hemodialysis.
Detailed description
To examine the pharmacokinetics, pharmacodynamics and safety in patients with chronic kidney disease undergoing hemodialysis.
- To assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and the effect of hemodialysis on PK of single oral administration of ASP7991 in Part 1.
- To assess the safety, PK and PD of repeated oral administration of ASP7991 in part 2.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1- single administration | Experimental | Drug: ASP7991The lowest, middle and the highest dose ASP7991 as a single oral administration on non-dialysis day in step 1 to 3 and the highest dose on day of dialysis in step 4. |
| Part 2- repeated administration | Experimental | Drug: ASP7991The lowest, middle and the highest dose ASP7991 as repeated oral administration in step 1 to 3. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week for more than 12 weeks (84 days) and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period
- Patients who have secondary hyperparathyroidism;
- Corrected serum Ca at screening：≥ 8.4 mg/dL
- No changes in items below at least 7 days before screening and do not have a plan to change something in the items below during the trial.
Key exclusion criteria (12 listed)
- Patients who underwent parathyroid intervention within 24 weeks prior to the informed consent
- Patients who have primary hyperparathyroidism
- Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract
- Patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 120 mmHg are showed at the previous three points at the initiation of dialysis including the screening assessment)
- Complicated by severe heart disorder [congestive cardiac failure (NYHA classification III or higher), or wide range of old myocardial infarction], or having a history of hospitalization for cerebro-vascular disease or heart disorder within 12 weeks(84 days) before obtaining the informed consent.
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 |
|---|---|---|
| ASP7991oral | Drug | Part 1- single administration, Part 2- repeated administration |
Primary outcome
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and ophthalmic examination
Time frame: For 9-16 days after dosing
2 secondary outcomes
Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F
Time frame: For 9-16 days after dosing
iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P
Time frame: For 9-16 days after dosing
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 6 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/.
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
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 ASP7991 in people with Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy and Pharmacodynamics of ASP7991, run by Astellas Pharma Inc at 1 site 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 8 inclusion and 12 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 6 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 1 site 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?
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and ophthalmic examination (time frame: For 9-16 days after dosing). 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 6 Nov 2024.