Clinical Research Directory

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.

Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies

The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney.The pilot study compares the use of rituximab (Rituxan®) + site-specific standard immunosuppression to placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant.

Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus

The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of semaglutide therapy in 37 KTR at risk of post-transplant diabetes mellitus (PTDM).

Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients

Most kidney transplant recipients take a combination of anti-rejection medicines for the rest of their life. One of these is called mycophenolate mofetil (MMF), also known by the brand name CellCept. While MMF helps protect the kidney, taking it for many years can cause infections, low blood counts, stomach problems, and a higher risk of certain cancers, problems that older adults are especially likely to experience. We are doing this study to learn whether carefully and slowly stopping MMF in older adults who are doing well after their transplant is as safe as continuing MMF, when we use blood and urine tests to closely watch for any early signs of trouble. The information learned could help future kidney transplant patients use less medicine without losing their transplant.

Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma

This is a phase II, multicenter, open label, single arm, non-randomized trial using Simon's optimal two-stage design to evaluate the efficacy of cemiplimab in kidney transplant recipients with advanced cutaneous squamous cell carcinoma. The hypothesis being tested is that cemiplimab alongside standardized immune suppression will generate anti-tumor activity without triggering allograft rejection.

Risk Factors Associated With the Absence of CMV-specific Cellular Immune Response in the Early Post-transplant Period in Low-risk CMV-seropositive Kidney Transplant Recipients

The goal of this observational study is to identify risk factors associated with the absence of CMV-specific cellular immune response in low-risk CMV-seropositive kidney transplant recipients in the early post-transplant period. The participant population includes adult CMV-seropositive kidney transplant recipients who did not receive antithymocyte globulin (ATG) induction therapy and underwent QuantiFERON-CMV testing within the first 45 days after transplantation. The main question it aims to answer is: \- Is it possible to predict which patients will fail to develop a CMV-specific cellular immune response before day 45 post-transplant in the absence of directly available immune assessment techniques? Researchers will compare patients with reactive QuantiFERON-CMV results to patients with non-reactive or indeterminate results to identify factors associated with the absence of CMV-specific cellular immune response. Participants will have retrospective clinical and laboratory data collected from medical records.

Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission

Donor organs often carry latent Cytomegalovirus (CMV) infection that may be transmitted to the recipient. The goal of this clinical trial is to determine the safety of SYN002 treatment during Ex-Vivo Organ Perfusion (EVOP) in clinical kidney transplantation. Donor kidneys will be treated on the EVOP system with SYN002 in order to decrease the burden of latent CMV in the organ and mitigate the transmission of cytomegalovirus (CMV).

Outcomes of a Pre-operative Exercise Programme for Live Donor and Recipient Kidney Transplant Patients

The goal of this clinical trial is to learn if a pre-operative outpatient exercise programme, monitored by a smart wearable device is acceptable to live kidney donor and recipient transplant patients. It will also look at the impact of prehabilitation on post operative outcomes. The main questions it aims to answer are: Is it feasible for renal transplant patients and live kidney donors to participate in a prehabilitation programme in combination with a piece of wearable technology? Are transplant outcomes improved by prehabilitation regimens delivered by video instruction? Are there discernible perioperative digital signatures provided by the wearable that link to surgical outcomes? Is the quality of perioperative sleep linked to surgical outcomes? Participants will: Wear a wrist or ring worn wearable device for a total of 14 weeks (2 week baseline, 6 week pre op and 6 week post op) Engage in a 6 week pre operative exercise programme at home/gym Keep a diary and answer surveys on their experience of the exercise regimen and wearable device