* 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.
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.
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).
Inability to provide informed consent.
Concurrent biopsy demonstrating rejection requiring treatment.
Pregnancy.
Previous PTA of the same vessel.
National prospective multicenter study with a primary endpoint at 3 months and annual follow-up for up to 10 years post-intervention, evaluating renal function, blood pressure, and clinical events. Patients with vascular complications, predominantly transplant renal artery stenosis (TRAS) following kidney transplantation, who meet at least one of the clinical inclusion criteria, may be enrolled in the study.
Cohort
Prospective
Catheter-based angiography
Diagnostic testCatheter-based angiography performed in accordance with the study protocol.
Measurement of translesional pressure gradients
Diagnostic testMeasurement of translesional pressure gradients performed in accordance with the study protocol.
Intravascular ultrasound (IVUS)
Diagnostic testIntravascular ultrasound (IVUS) performed in accordance with the study protocol.
Percutaneous transluminal angioplasty (PTA)
Procedure/SurgeryPercutaneous 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).
Change in measured glomerular filtration rate (mGFR).
Change in measured glomerular filtration rate (mGFR) at 3 months post-PTA compared with baseline.
Change in estimated glomerular filtration rate (eGFR).
Change in estimated glomerular filtration rate (eGFR) measured on day 1, day 7, day 21, at 6 weeks, at 3 and 12 months, and annually thereafter for up to 10 years post-PTA, compared with baseline.
Change in home systolic blood pressure.
Change in home systolic blood pressure measured on day 7, day 21, at 6 weeks, at 3 and 12 months, and annually thereafter for up to 10 years post-PTA, compared with baseline.
Change in attended automated office systolic blood pressure.
Change in attended automated office systolic blood pressure measured at 3, 12, and 24 months post-PTA, compared with baseline.
Change in unattended automated office systolic blood pressure.
Change in unattended automated office systolic blood pressure measured at 3, 12, and 24 months post-PTA, compared with baseline.
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Copenhagen University Hospital, Rigshospitalet
Collaborator
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Gødstrup Hospital
Collaborator
Holbaek Sygehus
Collaborator
Amsterdam UMC
Collaborator
The Augustinus Foundation, Denmark.
Collaborator
