NCT07415421

Parathyroidectomy After Kidney Transplantation

Subtotal Parathyroidectomy for the Treatment of Persistent Hyperparathyroidism After Kidney Transplantation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Persistent hyperparathyroidism is a frequent complication after kidney transplantation. Despite improved kidney function, many transplant recipients continue to have elevated parathyroid hormone (PTH) levels, often accompanied by hypercalcemia and/or hypophosphatemia. These disturbances are associated with adverse effects on skeletal health and have been linked to increased risk of fractures, graft dysfunction, and mortality. Currently, there are no evidence-based guidelines for the optimal management of persistent hyperparathyroidism after kidney transplantation. Conservative management with biochemical monitoring and supportive medical therapy is commonly used, while surgical parathyroidectomy is typically reserved for patients with severe biochemical abnormalities. Although parathyroidectomy is effective in normalizing PTH, calcium, and phosphate levels, and observational data suggest beneficial effects on bone mineral density, randomized controlled trials comparing surgical and conservative management strategies in this population are lacking. The purpose of this study is to evaluate the safety and efficacy of subtotal parathyroidectomy compared with conservative management in kidney transplant recipients with persistent hyperparathyroidism. The study is conducted as an open-label, randomized controlled pilot trial with a 12-month follow-up period. Kidney transplant recipients (\>6 mo after transplantation, no upper limit) 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. Controls will be treated with calcium, vitamin D and phosphate supplements as needed. Calcimimetic use is not mandated for controls, but can be utilized at the discretion of the treating physician. The primary objective is to assess the change in bone mineral density at the total hip after 12 months. Secondary objectives include evaluation of changes in mineral metabolism parameters, bone turnover markers, bone microarchitecture, physical function and muscle strength, quality of life and symptom burden, kidney graft function, and safety outcomes.

Conditions

• Hyperparathyroidism
• Kidney Transplantation Recipients

Interventions

Type	Name	Description
PROCEDURE	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.
OTHER	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.

Timeline

• Start date: 2026-01-20
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Denmark