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Phase 2 Study of KHK7580

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ClinicalTrials.gov Identifier: NCT02216656
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Brief Summary:
This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Drug: Placebo Drug: KHK7580 low dose Drug: KHK7580 middle dose Drug: KHK7580 high dose Drug: KRN1493 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis
Study Start Date : July 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Placebo Comparator: Plascebo Drug: Placebo
Oral administration

Experimental: KHK7580 low dose Drug: KHK7580 low dose
Oral administration

Experimental: KHK7580 middle dose Drug: KHK7580 middle dose
Oral administration

Experimental: KHK7580 high dose Drug: KHK7580 high dose
Oral administration

Active Comparator: KRN1493 Drug: KRN1493
Oral administration
Other Name: cinacalcet




Primary Outcome Measures :
  1. The percent changes in intact Parathyroid hormone levels from baseline [ Time Frame: Up to 3 weeks ]
    Percent changes in intact Parathyroid hormone levels from baseline to end of administration period


Secondary Outcome Measures :
  1. Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus. [ Time Frame: Up to 3 weeks ]
    Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period.

  2. Safety [ Time Frame: Up to 3 weeks ]
    1. Number and types of adverse events
    2. laboratory tests
    3. vital signs
    4. 12-lead electrocardiogram
    5. ophthalmological examination



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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:

  • Subjects who have voluntarily consented to participate in this study
  • Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening
  • Subjects with an intact Parathyroid hormone of >= 240 pg/mL at screening

Exclusion Criteria:

  • Subjects with primary hyperparathyroidism
  • Subjects who have received cinacalcet hydrochloride within 2 weeks before screening
  • Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.
  • Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.
  • Subjects with uncontrolled hypertension and/or diabetes
  • Subjects with severe heart disease.
  • Subjects with severe hepatic dysfunction.
  • Subjects who have received any other investigational drug within 12 weeks before screening
  • Other subjects unfit for participation in this study in the judgment of the investigator or 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): NCT02216656


Locations
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Japan
For additional information regarding investigative sites for this trial, contact 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: NCT02216656     History of Changes
Other Study ID Numbers: 7580-005
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists