Parathyroidectomy After Kidney Transplantation

NCT07415421 · tracked via the Priya Life Science Denmark tracker

Sponsor

Aarhus University Hospital

Phase

Not applicable

Started

2026-03-03

Last updated

2026-06-26

Condition(s) studied

HyperparathyroidismKidney Transplantation Recipients

Investigational drug(s) / intervention(s)

Subtotal ParathyroidectomyConservative Management

Subtotal 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.

Conservative 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion criteria * 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 minimum two separate biochemical measurements: PTH \> upper normal limit of assay and * serum ionized calcium ≥1.33 mmol/L or * serum total calcium ≥2.60 mmol/L or * serum phosphate ≤0.60 mmol/L despite sufficient dietary intake with measurements obtained within * 3 months in patients 6-12 months post-transplant * 6 months in patients \>12 months post-transplant and not attributable to calcium supplementation or treatment with thiazide diuretics or lithium. Exclusion criteria * 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.

Primary outcome measure(s)

Change in bone mineral density (BMD) at the total hip — From baseline to end of study at 12 months
Bone mineral density (BMD) at the total hip will be measured using dual-energy X-ray absorptiometry (DXA) according to standardized procedures. Measurements will be performed at baseline and after 12 months. The primary outcome is the change in bone mineral density from baseline to 12 months.

Trial sites (1)

Facility	City	Region	Status
Departement of Nephrology, Aarhus University hospital	Aarhus	Central Jutland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07415421 on ClinicalTrials.gov ↗ ← All trials in Denmark