SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

Secondary Hyperparathyroidism Clinical Trial

Official title:

SK-1403 Long-term Treatment Study - Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626948
• Other study ID #: AJ1003
• Status: Completed
• Phase: Phase 3
• Start date: September 13, 2018
• Est. completion date: February 5, 2020

Study information

• Verified date: March 2020
• Source: Sanwa Kagaku Kenkyusho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: February 5, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• SK-1403
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.

Locations

Country	Name	City	State
Japan	Investigational site (there may be other sites in this country)	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events or adverse drug reactions	Number of participants with adverse events or adverse drug reactions	52 weeks
Secondary	Rate of participants who achieved a serum iPTH level of = 60 pg/mL and = 240 pg/mL at each time point	Rate of participants who achieved a serum iPTH level of = 60 pg/mL and = 240 pg/mL at each time point; Assessed by laboratory test value	52 weeks
Secondary	Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product	Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product; Assessed by laboratory test value	52 weeks