Parathyroid surgery for persistent overactive parathyroid glands after kidney transplant.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Parathyroid removal to improve mobility in older adults

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• Dual-channel near-infrared imaging with AI to locate parathyroid glands

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.