Parathyroid surgery for persistent overactive parathyroid glands after kidney transplant.
Subtotal Parathyroidectomy for the Treatment of Persistent Hyperparathyroidism After Kidney Transplantation
This will test whether removing part of the parathyroid glands helps kidney transplant recipients who still have high parathyroid hormone and abnormal calcium or phosphate levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | denosumab, romosozumab |
| Locations | 1 site (Aarhus, Central Jutland) |
| Trial ID | NCT07415421 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized pilot trial will assign kidney transplant recipients more than 6 months after transplantation to either subtotal parathyroidectomy or conservative management in a 1:1 ratio. Eligible participants must have stable graft function (eGFR >= 30 ml/min/1.73 m2) and persistent biochemical evidence of hyperparathyroidism with hypercalcemia or hypophosphatemia. Participants are followed for 12 months with outcomes including bone mineral density, physical function, quality of life, symptom burden, and safety measures such as graft function and calcium handling. The design aims to compare clinical benefits and harms of surgical versus conservative approaches to persistent post-transplant hyperparathyroidism.
Who should consider this trial
Good fit: Ideal candidates are adults (>=18 years) more than 6 months after kidney transplant with stable graft function (eGFR >=30), persistently elevated PTH (>=1.5× assay limit) and either hypercalcemia or low phosphate, who are fit for surgery and able to consent in Danish.
Not a fit: Patients who are not surgical candidates, have had prior parathyroidectomy, are taking anti-resorptive or anabolic bone therapies, or have only mild biochemical abnormalities may not receive benefit from surgery.
Why it matters
Potential benefit: If successful, surgery could normalize PTH and calcium/phosphate levels and improve bone density, muscle function, symptoms, and potentially reduce fracture risk and related complications.
How similar studies have performed: Observational studies report that parathyroidectomy often normalizes PTH and can improve bone mineral density, but randomized trials in kidney transplant recipients are lacking.
Eligibility criteria
Show full inclusion / exclusion 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 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 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.
Where this trial is running
Aarhus, Central Jutland
- Departement of Nephrology, Aarhus University hospital — Aarhus, Central Jutland, Denmark (Recruiting)
Study contacts
- Principal investigator: Hanne S Jørgensen, MD, PhD — Department of Nephrology, Aarhus University Hospital
- Study coordinator: Hanne S Jørgensen, MD, PhD
- Email: hsjorgensen@clin.au.dk
- Phone: +45 51 41 35 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.