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Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01872026
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy Pharmacodynamics of ASP7991 Pharmacokinetics of ASP7991 Drug: ASP7991 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: ASP7991 Clinical Pharmacological Study -Examination of Pharmacokinetics and Pharmacodynamics in Chronic Kidney Disease Patients Undergoing Hemodialysis
Actual Study Start Date : December 26, 2012
Actual Primary Completion Date : June 26, 2013
Actual Study Completion Date : June 26, 2013

Resource links provided by the National Library of Medicine


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.
Drug: ASP7991
oral

Experimental: Part 2- repeated administration
The lowest, middle and the highest dose ASP7991 as repeated oral administration in step 1 to 3.
Drug: ASP7991
oral




Primary Outcome Measures :
  1. 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 Measures :
  1. Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F [ Time Frame: For 9-16 days after dosing ]
  2. iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P [ Time Frame: For 9-16 days after dosing ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

    1. Receiving Active vitamin D or Cinacalcet hydrochloride
    2. 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.

    1. Dose and type of Active Vitamin D, Calcitonin preparation, Phosphate binder.
    2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872026


Locations
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Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc

Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01872026     History of Changes
Other Study ID Numbers: 7991-CL-1003
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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."

Keywords provided by Astellas Pharma Inc:
ASP7991
Plasma concentration
Pharmacodynamics
Pharmacokinetics

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency