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Trial record 51 of 111 for:    CALCIUM CATION

Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

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: NCT02143271
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Brief Summary:
This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Drug: KHK7580 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-dose Phase 1 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: KHK7580 Drug: KHK7580
Oral administration




Primary Outcome Measures :
  1. Number and types of adverse events [ Time Frame: For 8 days ]
    The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram


Secondary Outcome Measures :
  1. Profiles of pharmacokinetics [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose ]
    intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening
  • intact parathyroid hormone value ≥ 240 pg/mL at the screening
  • Corrected serum calcium ≥ 8.4 mg/dL at the screening

Exclusion Criteria:

  • Patients with primary hyperparathyroidism
  • Patients who received cinacalcet within 2 weeks prior to the screening
  • Patients who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
  • Patients who underwent parathyroidectomy and/or parathyroid intervention
  • Patients with uncontrolled hypertension and/or diabetes
  • Patients with severe heart disorder
  • Patients with severe hepatic disease
  • Patients who take investigational drug in another clinical trial within 12 weeks prior to the screening
  • Patients who have been judged ineligible to participate in the study by the 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): NCT02143271


Locations
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Japan
Kyowa Hakko Kirin
Tokyo, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.

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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02143271    
Other Study ID Numbers: 7580-004
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015
Keywords provided by Kyowa Kirin Co., Ltd.:
Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases