A randomized, prospective study comparing cinacalcet and parathyroidectomy in kidney transplant recipients with hyperparathyroidism

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005333

Enrollment

Registered

2020-08-24

Start date

2021-09-13

Completion date

Unknown

Last updated

2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Procedure/Surgery : The Arm 1 will be prescribed cinacalcet, and the Arm 2 will be received parathyroidectomy. Parathyroidectomy will be performed by experienced surgeons with standard method.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria - At least 1 year after kidney transplantation - Estimated glomerular filtration rate = 30 ml/min - Intact PTH = 150 pg/mL & serum calcium > 10.2 mg/dL or intact PTH > 65.0 pg/mL & serum calcium > 11.0 mg/dL

Exclusion criteria

Exclusion criteria: Exclusion Criteria - Patients < 19 years old or = 70 years old - Patients who received previous neck surgery - Patients who received other organ transplantation - Patients who had other malignancy history - Patients who have hypersensitivity to cinacalcet - Patients who are pregnant or breastfeeding - Patients who have intolerable condition to surgery - Patients who have galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Design outcomes

Primary

Measure	Time frame
The proportion of patients with normocalcemia at 12 months	—

Secondary

Measure	Time frame
Intact PTH level;serum phosphorus;renal function;Vascular calcification;Bone densitometry;Bone markers;Fracture events;Incidence of acute rejection;Kidney graft survival;Severe hypocalcemia	—

Countries

Korea, Republic of

Contacts

Public ContactChung Hee Baek

Asan Medical Center

bch393@naver.com+82-2-3010-1481

Outcome results