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Recruiting
NCT07415421
Parathyroidectomy After Kidney Transplantation
Conditions: Hyperparathyroidism, Kidney Transplantation Recipients
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 85
Sponsor: Aarhus University Hospital
Location: Departement of Nephrology, Aarhus University hospital Aarhus Central Jutland
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07415421). StuddyBuddy aggregates publicly available trial information.