- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872026
Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis
November 26, 2018 updated by: Astellas Pharma Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kantou, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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%)
Exclusion Criteria:
- 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)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1- single administration
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.
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oral
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Experimental: Part 2- repeated administration
The lowest, middle and the highest dose ASP7991 as repeated oral administration in step 1 to 3.
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oral
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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For 9-16 days after dosing
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F
Time Frame: For 9-16 days after dosing
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For 9-16 days after dosing
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iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P
Time Frame: For 9-16 days after dosing
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For 9-16 days after dosing
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 26, 2012
Primary Completion (Actual)
June 26, 2013
Study Completion (Actual)
June 26, 2013
Study Registration Dates
First Submitted
June 5, 2013
First Submitted That Met QC Criteria
June 5, 2013
First Posted (Estimate)
June 7, 2013
Study Record Updates
Last Update Posted (Actual)
November 27, 2018
Last Update Submitted That Met QC Criteria
November 26, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7991-CL-1003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ASP7991
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Astellas Pharma IncCompletedHealthy | Pharmacokinetics of ASP7991Japan
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Astellas Pharma IncCompletedHealthy | Pharmacokinetics of ASP7991Japan
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Astellas Pharma IncCompletedSecondary HyperparathyroidismJapan