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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01872026
First received: June 5, 2013
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: ASP7991 Clinical Pharmacological Study -Examination of Pharmacokinetics and Pharmacodynamics in Chronic Kidney Disease Patients Undergoing Hemodialysis

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

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 [ Time Frame: For 9-16 days after dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F [ Time Frame: For 9-16 days after dosing ] [ Designated as safety issue: No ]
  • iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P [ Time Frame: For 9-16 days after dosing ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872026

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01872026     History of Changes
Other Study ID Numbers: 7991-CL-1003
Study First Received: June 5, 2013
Last Updated: July 8, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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

ClinicalTrials.gov processed this record on September 18, 2014