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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02549417
Other study ID # 7580-012
Secondary ID
Status Completed
Phase Phase 3
First received September 9, 2015
Last updated July 2, 2017
Start date September 29, 2015
Est. completion date December 22, 2016

Study information

Verified date July 2017
Source Kyowa Hakko Kirin Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date December 22, 2016
Est. primary completion date December 22, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Personally submitted written voluntary informed consent to participate in the study

- Stable chronic renal disease treated with peritoneal dialysis for at least 16 weeks before screening

- Intact PTH level of > 240 pg/ml at screening

Exclusion Criteria:

- Treatment with cinacalcet hydrochloride within 2 weeks before screening;

- Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;

- Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;

- Severe heart disease;

- Severe hepatic dysfunction;

- Uncontrolled hypertension and/or diabetes;

- Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;

- Primary hyperparathyroidism;

- Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

Study Design


Intervention

Drug:
KHK7580
Oral administration

Locations

Country Name City State
Japan For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of = 60 pg/mL and = 240 pg/mL Weeks 30-32
Secondary Percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of = 30% (percent change = -30%) from baseline Weeks 30-32
Secondary Mean percent change in the evaluation period in intact PTH level from baseline Weeks 30-32
See also
  Status Clinical Trial Phase
Completed NCT02549404 - Phase 3 Study of KHK7580 Phase 3
Not yet recruiting NCT02536287 - Comparison of Total Parathyroidectomy With and Without Autotransplantation Phase 3
Completed NCT02549391 - Phase 3 Study of KHK7580 Phase 2/Phase 3
Active, not recruiting NCT03023748 - Intravenous Paricalcitol in Chronic Hemodialysis Patients Phase 4
Withdrawn NCT01426724 - Effects of Vitamin D on Renal Blood Flow, Proteinuria and Inflammation in Patients With Chronic Kidney Disease N/A
Completed NCT01101113 - Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level Phase 4
Completed NCT01220050 - Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism Phase 2
Completed NCT00537979 - Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis Phase 4
Completed NCT00431496 - A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD) Phase 4
Completed NCT00379899 - ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis Phase 4
Completed NCT00117052 - SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism Phase 3
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