About this trial
* 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
Qualifiers
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).
Disqualifiers
Inability to provide informed consent.
Concurrent biopsy demonstrating rejection requiring treatment.
Pregnancy.
Previous PTA of the same vessel.
Trial design
Treatments tested in this trial
- Catheter-based angiography
- Measurement of translesional pressure gradients
- Intravascular ultrasound (IVUS)
- Percutaneous transluminal angioplasty (PTA)
Treatment groups
Sponsors and collaborators
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Gødstrup Hospital
Collaborator
Holbaek Sygehus
Collaborator
Amsterdam UMC
Collaborator
The Augustinus Foundation, Denmark.
Collaborator