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

NCT03626948 | Completed Phase 3

• 1 other identifier: AJ1003
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events or adverse drug reactions

  Number of participants with adverse events or adverse drug reactions

  52 weeks

Secondary Outcomes (2)

• 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

Study Arms (1)

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.

Drug: SK-1403

Interventions

SK-1403 DRUG

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.

SK-1403

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanwa Kagaku Kenkyusho Co., Ltd.: lead

Study Sites (1)

Investigational site (there may be other sites in this country)

Tokyo, Japan

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: September 13, 2018
• Primary Completion: February 4, 2020
• Study Completion: February 5, 2020
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

JP (1)