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NCT Number: NCT07531966

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 the most common. * To assess whether novel imaging and functional diagnostic methods can predict treatment response.

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Key information

About this study

Kidney transplantation is performed 250-300 times annually in Denmark and substantially improves survival, quality of life, and reduces the burden of comorbidities in patients with end-stage kidney disease. Despite these benefits, vascular complications, particularly transplant renal artery stenosis (TRAS), remain a major cause of morbidity. Reported incidence of TRAS varies widely (1-23%), reflecting retrospective study designs and inconsistent diagnostic criteria. TRAS are classified into three main types: anastomotic (TRAS-A), post-anastomotic (TRAS-P), and long-segment bend/kink (TRAS-B), with most cases diagnosed within the first two years post-transplant. Severe stenoses can critically impair graft perfusion, leading to reduced renal function and treatment-resistant hypertension.

Percutaneous transluminal angioplasty (PTA) for TRAS is a well-established procedure performed according to the same principles as coronary balloon angioplasty; however, the role of stent placement remains uncertain. PTA without stenting is associated with higher restenosis rates compared to PTA with stenting, yet evidence regarding graft function, survival, and blood-pressure control remains conflicting.

Adverse events related to PTA occur in approximately 10% of patients and are generally mild. Serious adverse events are observed in fewer than 5% of patients and include procedure-related internal bleeding and vascular access-site complications. Severe internal bleeding may require blood transfusion and endovascular vessel occlusion and can, in rare cases, result in loss of the transplanted kidney. Access-site vascular complications may present as bleeding, thrombosis, or pseudoaneurysm.

Against this background, the nationwide prospective multicentre DAN-PTRAIII study aims to establish the true incidence of arterial inflow and venous outflow problems in Danish kidney-transplant recipients, evaluate the efficacy and safety of balloon angioplasty, and explore novel imaging and functional diagnostic methods for predicting treatment response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one of the following clinical criteria (1 or 2) must be fulfilled:
  • 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.
  • 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:

  • CT or MR angiography demonstrating a lumen reduction ≥50%.
  • Doppler ultrasound showing:
  • Peak systolic velocity in the renal artery ≥200 cm/s and a renal renal ratio (velocity at stenosis / velocity in distal artery) >4.
  • Acceleration time >70 ms in intrarenal arteries.
  • 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:

  • Stenosis ≥70%.
  • 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

  • Inability to provide informed consent.
  • Concurrent biopsy demonstrating rejection requiring treatment.
  • Pregnancy.
  • Previous PTA of the same vessel.
  • Patients unable to tolerate any form of antithrombotic therapy and therefore not eligible for stent placement.

Treatment and study plan

Catheter-based angiography

Diagnostic Test

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

Measurement of translesional pressure gradients

Diagnostic Test

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

Intravascular ultrasound (IVUS)

Diagnostic Test

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

Percutaneous transluminal angioplasty (PTA)

Procedure

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).

Primary outcomes

  1. Change in measured glomerular filtration rate (mGFR).

    Time frame: Baseline and 3 months post-PTA.

    Change in measured glomerular filtration rate (mGFR) at 3 months post-PTA compared with baseline.

Secondary outcomes

  1. Change in estimated glomerular filtration rate (eGFR).

    Time frame: Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, 12 months, and annually thereafter for up to 10 years post-PTA.

    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.

  2. Change in home systolic blood pressure.

    Time frame: Baseline, Day 7, Day 21, 6 weeks, 3 months, 12 months, and annually thereafter for up to 10 years post-PTA.

    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.

  3. Change in attended automated office systolic blood pressure.

    Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.

    Change in attended automated office systolic blood pressure measured at 3, 12, and 24 months post-PTA, compared with baseline.

  4. Change in unattended automated office systolic blood pressure.

    Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.

    Change in unattended automated office systolic blood pressure measured at 3, 12, and 24 months post-PTA, compared with baseline.

  5. Change in 24-hour ambulatory systolic blood pressure.

    Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.

    Change in 24-hour ambulatory systolic blood pressure measured at 3, 12, and 24 months post-PTA, compared with baseline.

  6. Change in defined daily dose (DDD) of antihypertensive medications.

    Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.

    Change in defined daily dose (DDD) of antihypertensive medications at 3, 12, and 24 months post-PTA compared with baseline.

  7. Change in the number of antihypertensive medications.

    Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.

    Change in the number of antihypertensive medications at 3, 12, and 24 months post-PTA compared with baseline.

  8. Change in 24-hour ambulatory systolic blood pressure adjusted for changes in antihypertensive medication.

    Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.

    Change in 24-hour ambulatory systolic blood pressure measured at 3, 12, and 24 months post-PTA, compared with baseline, adjusted for changes in antihypertensive medication (5 mmHg per DDD).

  9. Health status on 12-item Short Form Health Survey (SF-12).

    Time frame: Baseline and 3 months post-PTA.

    Change in 12-item Short Form Health Survey (SF-12) scores at 3 months post-PTA, compared with baseline.

    Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

  10. Number of clinical events after PTA.

    Time frame: 10 years post-PTA.

    Cardiovascular and renal events are defined according to the criteria used in the DAPA-CKD study, with the modification that end-stage kidney disease is defined exclusively as either kidney transplantation or chronic dialysis. After PTA treatment, the following clinical events will be recorded for 10 years:

    • Cardiovascular death
    • Renal death
    • Death from non-cardiovascular and non-renal causes
    • Stroke
    • Myocardial infarction
    • Hospitalization for heart failure
    • Reduction in eGFR ≥50% from baseline for ≥28 days, not fulfilling the definition of end-stage kidney disease
    • End-stage kidney disease, defined as kidney transplantation or chronic dialysis for ≥28 days
    • Biopsy-proven rejection
    • Need for repeat PTA due to restenosis or in-stent thrombosis
  11. Number of serious adverse events (SAEs), procedure-related adverse events (≤24 hours), and postoperative adverse events (>24 hours) occurring within 30 days after the procedure.

    Time frame: 30 days post-PTA.

    All SAEs, procedure-related adverse events (≤24 hours), and postoperative adverse events (>24 hours) occurring within 30 days after the procedure will be systematically recorded. Events include, but are not limited to:

    • Death from any cause
    • Rupture, dissection, occlusion, or perforation of the graft artery
    • Stent thrombosis post-PTA
    • Embolic adverse events to the kidney or peripheral circulation (upper or lower extremity depending on access route)
    • Bleeding requiring transfusion
    • Embolization or nephrectomy due to bleeding or other adverse event
    • Access-related complications requiring treatment. Defined as bleeding at the puncture site necessitating additional hospitalization, transfusion, or surgical intervention, including thrombin injection for pseudoaneurysm. The definition also includes thrombosis of the access vessel causing ischemic symptoms or requiring surgical intervention.
    • Need for acute dialysis
    • Clinical events as defined above
  12. Doppler ultrasound.

    Time frame: Baseline and 3 months post-PTA.

    Diagnostic utility and predictive value for treatment response to PTA.

  13. Invasive pressure measurements across stenoses.

    Time frame: Baseline and 3 months post-PTA.

    Diagnostic utility and predictive value for treatment response to PTA.

  14. Intravascular ultrasound.

    Time frame: Baseline and 3 months post-PTA.

    Diagnostic utility and predictive value for treatment response to PTA.

  15. Non-invasive fractional flow reserve computed tomography (FFR-CT) / computational fluid dynamics (CFD) simulation.

    Time frame: Baseline and 3 months post-PTA.

    Diagnostic utility and predictive value for treatment response to PTA.

  16. Functional magnetic resonance imaging.

    Time frame: Baseline and 3 months post-PTA.

    Diagnostic utility and predictive value for treatment response to PTA.

Study contacts

Contact information is provided by the study sponsor or research team.

Henrik Birn, MD, DMSc

CONTACT

[email protected]

Mark Reinhard, MD, PhD

CONTACT

[email protected]

+45 40460321

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Amsterdam UMC
  • Gødstrup Hospital
  • Holbaek Sygehus
  • Odense University Hospital
  • Rigshospitalet, Denmark
  • The Augustinus Foundation, Denmark.

Registry information

Official study title

Vascular Complications After Kidney Transplantation: A Prospective National Multicenter Study - The DAN-PTRAIII Study

Acronym: DAN-PTRAIII

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Apr 15, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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