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Clinical Trials in Denmark / NCT07531966
Recruiting Observational

Vascular Complications After Kidney Transplantation

NCT07531966 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2026-05-22
Last updated
2026-05-27

Condition(s) studied

Kidney Transplant RecipientKidney Transplant; ComplicationsTransplant Renal Artery StenosisRenovascular DiseaseRenal Transplant Graft FailureRenovascular HypertensionHeart Failure

Investigational drug(s) / intervention(s)

Catheter-based angiographyMeasurement of translesional pressure gradientsIntravascular ultrasound (IVUS)Percutaneous transluminal angioplasty (PTA)

Catheter-based angiography: Catheter-based angiography performed in accordance with the study protocol.

Measurement of translesional pressure gradients: Measurement of translesional pressure gradients performed in accordance with the study protocol.

Intravascular ultrasound (IVUS): Intravascular ultrasound (IVUS) performed in accordance with the study protocol.

Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is performed in accordance with the study protocol. As a general principle, bare-metal stents (BMS) are used. Drug-eluting stents (DES) may be considered when the arterial lumen diameter is \< 4-5 mm. In stenoses where stent placement carries a risk of side-branch occlusion, PTA is performed without stent implantation and most often with a drug-coated balloon (DCB).

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
Odense University Hospital Odense Denmark Recruiting

More University of Aarhus trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07531966 on ClinicalTrials.gov ↗ ← All trials in Denmark