NCT03626948CompletedPhase 3
SK-1403 Long-term Treatment Study - Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis -
Sanwa Kagaku Kenkyusho Co., Ltd.1 site in 1 country157 target enrollmentStarted: September 13, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 157
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events or adverse drug reactions
Study Overview
Brief Summary
To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Serum PTH>240 pg/mL at the screening
- •Serum corrected Ca≥8.4 mg/dL at the screening
- •Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration
Exclusion Criteria
- •Primary hyperparathyroidism
- •Severe liver disease
- •Severe cardiac disease
- •History or family history of long QT syndrome
- •Malignant tumor
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypertension
- •A history of severe drug allergy
Arms & Interventions
SK-1403
Experimental
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment.
Intervention: SK-1403 (Drug)
Outcomes
Primary Outcomes
Number of participants with adverse events or adverse drug reactions
Time Frame: 52 weeks
Number of participants with adverse events or adverse drug reactions
Secondary Outcomes
- Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point(52 weeks)
- Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product(52 weeks)
Investigators
Study Sites (1)
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