Hyperparathyroidism Clinical Trials

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Subtotal Parathyroidectomy for the Treatment of Persistent Hyperparathyroidism After Kidney Transplantation

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Departement of Nephrology, Aarhus University hospital
RECRUITING
Aarhus
Contact Information
Primary
Hanne S Jørgensen, MD, PhD
hsjorgensen@clin.au.dk
+45 51 41 35 41
Backup
Amal Derai, MD
amader@rm.dk
+45 51 36 03 80
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 85
Treatments
Experimental: Surgery group
Participants assigned to this arm will undergo 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 will be used to guide the extent of resection, in accordance with standard surgical principles. Surgery will be performed by experienced ear, nose and throat (ENT) surgeons. Participants will receive standard perioperative care and postoperative follow-up.
Active_comparator: Control group
Participants assigned to this arm will receive conservative management according to standard clinical practice. This includes 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 at the discretion of the treating physician. No parathyroid surgery will be performed during the 12-month study period.
Sponsors
Collaborators: University of Aarhus
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov

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