Back to resultsExamination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis
Primary Purpose
Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy, Pharmacodynamics of ASP7991, Pharmacokinetics of ASP7991
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ASP7991
Sponsored by
About this trial
This is an interventional other trial for Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy focused on measuring ASP7991, Plasma concentration, Pharmacodynamics, Pharmacokinetics
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part 1- single administration
Part 2- repeated administration
Arm Description
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.
The lowest, middle and the highest dose ASP7991 as repeated oral administration in step 1 to 3.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F
iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01872026
Brief Title
Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis
Official Title
ASP7991 Clinical Pharmacological Study -Examination of Pharmacokinetics and Pharmacodynamics in Chronic Kidney Disease Patients Undergoing Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 26, 2012 (Actual)
Primary Completion Date
June 26, 2013 (Actual)
Study Completion Date
June 26, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy, Pharmacodynamics of ASP7991, Pharmacokinetics of ASP7991
Keywords
ASP7991, Plasma concentration, Pharmacodynamics, Pharmacokinetics
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1- single administration
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2- repeated administration
Arm Type
Experimental
Arm Description
The lowest, middle and the highest dose ASP7991 as repeated oral administration in step 1 to 3.
Intervention Type
Drug
Intervention Name(s)
ASP7991
Intervention Description
oral
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F
Time Frame
For 9-16 days after dosing
Title
iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P
Time Frame
For 9-16 days after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Kantou
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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."
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=276
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis
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