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Completed

NCT Number: NCT02143271

Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

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

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyowa Hakko Kirin

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KHK7580

Drug

Oral administration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Single-dose Phase 1 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 21, 2014
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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