Parathyroidectomy After Kidney Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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
Qualifiers
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
serum ionized calcium ≥1.33 mmol/L or
Disqualifiers
Inability to provide written, informed consent
Current anti-resorptive therapy (bisphosphonate, denosumab)
Current bone anabolic therapy (teriparatide, romosozumab)
Previous surgical parathyroidectomy
Trial design
Treatments tested in this trial
- Subtotal Parathyroidectomy
- Conservative Management
Treatment groups
85 Participants
are divided into 2 treatment groupsSponsors and collaborators
Aarhus University Hospital
Lead sponsor
University of Aarhus
Collaborator
Source ClinicalTrials.gov