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

S

Sanwa Kagaku Kenkyusho

Status and phase

Completed
Phase 3

Conditions

Secondary Hyperparathyroidism

Treatments

Drug: SK-1403

Study type

Interventional

Funder types

Industry

Identifiers

NCT03626948
AJ1003

Details and patient eligibility

About

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

Enrollment

157 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

157 participants in 1 patient group

SK-1403
Experimental group
Description:
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.
Treatment:
Drug: SK-1403

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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