Secondary Hyperparathyroidism Clinical Trial
Official title:
Phase 3 Study of KHK7580 (A Clinical Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Peritoneal Dialysis)
Verified date | July 2017 |
Source | Kyowa Hakko Kirin Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Japan | For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Kyowa Hakko Kirin Co., Ltd |
Japan,
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 |
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