New study aims to uncover hidden causes of kidney transplant failure
NCT ID NCT07531966
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 60 kidney transplant recipients in Denmark to find out how often blood vessel problems cause poor kidney function or hard-to-treat high blood pressure. Participants will get special imaging tests, and if a narrowed artery is found, they may receive balloon treatment to open it. The goal is to improve diagnosis and treatment for these complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Catheter-based balloon treatment (angioplasty)
- What this could lead to
- If successful, this could lead to better detection and treatment of blood vessel problems after kidney transplant, improving kidney function and blood pressure control.
- What could go wrong
- This is an early observational study with only 60 participants, so results may not apply to all patients. The balloon treatment carries risks like vessel damage or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aarhus University Hospital
RECRUITINGAarhus, 8200, Denmark
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Odense University Hospital
RECRUITINGOdense, 5000, Denmark
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Rigshospitalet
RECRUITINGCopenhagen, 2100, Denmark
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