RecruitingNot ApplicableNCT07415421

Parathyroidectomy After Kidney Transplantation

Subtotal Parathyroidectomy for the Treatment of Persistent Hyperparathyroidism After Kidney Transplantation

Sponsor

Aarhus University Hospital

Enrollment

85 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

Hyperparathyroidism Kidney Transplantation Recipients

Summary

This study aims to clarify whether surgical treatment of persistent hyperparathyroidism after kidney transplantation offers clinically meaningful benefits compared with a conservative treatment strategy. Kidney transplant recipients (\>6 mo after transplantation) with persistent hyperparathyroidism (elevated PTH and either hypercalcemia or hypophosphatemia) will be randomized in a 1:1 ratio to either subtotal parathyroidectomy or conservative management according to standard clinical practice. The study is conducted as an open-label, randomized controlled pilot trial with a 12-month follow-up period. Outcomes include bone density, physical function, quality of life and symptom burden.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Age \> 18 years and legally competent and able to understand spoken and written Danish
Kidney transplantation ≥ 6 months prior (no upper limit of time after transplantation)
Stable kidney graft function, defined as estimated GFR ≥ 30 ml/min/1.73m3
On two consecutive biochemical measurements: PTH ≥1.5 times normal limit of assay and ionized calcium ≥1.35 mmol/L or albumin-corrected calcium ≥2.70 mmol/L or phosphate ≤0.50 mmol/L

Exclusion Criteria6

Inability to provide written, informed consent
Current anti-resorptive therapy (bisphosphonate, denosumab)
Current bone anabolic therapy (teriparatide, romosozumab)
Previous surgical parathyroidectomy
Not considered fit for surgery (including pregnancy)
Ionized calcium ≥1.50 mmol/L or albumin-corrected calcium ≥3.00 mmol/L despite discontinuation of calcium supplements.

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Interventions

PROCEDURESubtotal Parathyroidectomy

Subtotal parathyroidectomy performed according to standard surgical practice. The procedure involves removal of the majority of parathyroid tissue with preservation of a small remnant. Intraoperative parathyroid hormone (PTH) measurements are used to guide the extent of resection. Standard perioperative care and postoperative follow-up are provided.

OTHERConservative Management

Conservative management according to standard clinical practice, including regular clinical follow-up and biochemical monitoring of calcium, phosphate, and parathyroid hormone levels. Medical treatment, such as calcium or vitamin D supplementation and/or calcimimetic therapy, may be initiated or adjusted based on clinical judgment.