BridgeMD
New treatment option for Hyperparathyroidism
Official title Parathyroidectomy After Kidney Transplantation
ClinicalTrials.gov ID: NCT07415421
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Central Jutland, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Central Jutland, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.