Recruiting

Vascular Complications After Kidney Transplantation

* 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…

ClinicalTrials.gov IDNCT07531966
PhaseNot Applicable
Enrollment60
SponsorUniversity of Aarhus
Age18 Years
SexALL
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Conditions studied

Kidney Transplant Recipient, Kidney Transplant; Complications, Transplant Renal Artery Stenosis, Renovascular Disease, Renal Transplant Graft Failure, Renovascular Hypertension, Heart Failure

About this study

* 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.

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.