NCT07531966 Vascular Complications After Kidney Transplantation
| NCT ID | NCT07531966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Kidney Transplant Recipient |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-22 |
| Primary Completion | 2031-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-05-22 with a primary completion date of 2031-03-31.
⚠ 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
* To determine the incidence of arterial inflow problems and venous outflow problems as causes of impaired renal function and/or treatment-resistant hypertension after kidney transplantation, when all kidney-transplant recipients in Denmark are evaluated according to uniform, well-defined clinical criteria. * To investigate the efficacy and safety of catheter-based balloon treatment (percutaneous transluminal angioplasty, PTA) for these vascular complications, of which transplant renal artery stenosis is by far the most common. * To assess whether novel imaging and functional diagnostic methods can predict treatment response.
Eligibility Criteria
Inclusion Criteria: 1\. At least one of the following clinical criteria (1 or 2) must be fulfilled: 1. Graft dysfunction, defined by at least one of the following: * Acute reduction in estimated glomerular filtration rate (eGFR) \>15% on two consecutive measurements at least 2 weeks apart, with other causes excluded (rejection, obstruction, infection). * eGFR \<50% of the expected value 30 days after kidney transplantation of unknown cause. * Decline in eGFR \>30% after initiation of an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker. 2. Persistent resistant hypertension for more than 6 weeks after kidney transplantation, defined as: * 24-hour ambulatory systolic blood pressure \>130 mmHg despite treatment with at least three classes of antihypertensive medication at maximally tolerated doses (including diuretics, if tolerated). Together with at least one of the following radiological criteria: 1. CT or MR angiography demonstrating a lumen reduction ≥50%. 2. Doppler ultrasound showing: 1. Peak systolic velocity in the renal artery ≥200 cm/s and a renal renal ratio (velocity at stenosis / velocity in distal artery) \>4. 2. Acceleration time \>70 ms in intrarenal arteries. 2\. In cases of strong clinical suspicion of a vascular complication where CT or MR angiography cannot reliably exclude graft artery or vein stenosis, patients may be referred for confirmatory invasive investigations. Before PTA, catheter-based angiography and translesional pressure measurements are performed to confirm whether the patient meets the radiological eligibility criterion for PTA: 1. Stenosis ≥70%. 2. Stenosis 50-69% if at least one of the following criteria is met: * Mean translesional pressure gradient ≥10 mmHg. * Systolic pressure gradient ≥20 mmHg. * Renal Pd/Pa ≤0.8. * If pressure measurements cannot be obtained, treatment is based on the operator's clinical judgement. Exclusion Criteria: 1. Inability to provide informed consent. 2. Concurrent biopsy demonstrating rejection requiring treatment. 3. Pregnancy. 4. Previous PTA of the same vessel. 5. Patients unable to tolerate any form of antithrombotic therapy and therefore not eligible for stent placement.
Contact & Investigator
Mark Reinhard, MD, PhD
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT07531966 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Transplant Recipient. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07531966 currently recruiting?
Yes, NCT07531966 is actively recruiting participants. Contact the research team at markrein@rm.dk for enrollment information.
Where is the NCT07531966 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Copenhagen, Denmark, Odense, Denmark.
Who is sponsoring the NCT07531966 clinical trial?
NCT07531966 is sponsored by University of Aarhus. The principal investigator is Mark Reinhard, MD, PhD at Aarhus University Hospital. The trial plans to enroll 60 participants.
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