NCT07415421 Parathyroidectomy After Kidney Transplantation
| NCT ID | NCT07415421 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aarhus University Hospital |
| Condition | Hyperparathyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 85 participants in total. It began in 2026-01-20 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Hanne S Jørgensen, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Nephrology, Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT07415421 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hyperparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07415421 currently recruiting?
Yes, NCT07415421 is actively recruiting participants. Contact the research team at hsjorgensen@clin.au.dk for enrollment information.
Where is the NCT07415421 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT07415421 clinical trial?
NCT07415421 is sponsored by Aarhus University Hospital. The principal investigator is Hanne S Jørgensen, MD, PhD at Department of Nephrology, Aarhus University Hospital. The trial plans to enroll 85 participants.