Clinical Research Directory

Tolerance Through Mixed Chimerism (Sip-Tego)

This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.

Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus

This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol.

Posttranslationally Modified Fetuin-A in Urine as a Marker for Renal Dysfunction (Patients With Chronic Kidney Disease - With or Without Kidney Transplantation).

Kidney transplantation is the preferred treatment method for patients with chronic kidney disease. Standard parameters (estimated glomerular filtration, albuminuria) of renal function detection are limited by many factors, therefore they are considered insufficient. Urinary post-translationally modified fetuin A (uPTM-FeA) appears to be a promising biomarker for the early detection of impaired renal function. Increased values were detected in patients with diabetic kidney disease, acute kidney injury and interstitial fibrosis/tubular atrophy. Patients after kidney transplantation will be included in our analysis, in which the value of uPTM-FeA at the time of kidney graft biopsy performing (indication/ protocolar) and 6th months after biopsy. The study will also include the patients with chronic kidney disease after renal biopsy, when the value of uPTM-FeA be examined and then 6 months after renal biopsy. The analysis will be correlated with the basic characteristics of the donor and recipient, with the results of protocol or indication biopsy, rejection, level and dose of immunosuppression and parameters detecting renal function. The analysis will be correlated with the histopatology result of kidney biopsy. The study also include patients with chronic kidney disease or acute kidney injury, who undergo renal biopsy. The value of uPTM-FeA be examined at the time of kidney biopsy and then 6 months after and correlated with the basic laboratory parametres and the results biopsy. The aim of our study is to confirm the reliability of uPTM-FeA as a marker of kidney graft failure with the perspective of including uPTM-FeA examination in routine examination methods. Early detection of kidney graft failure can help save not only the graft, but also prolong the patient's life. And the second aim is correlated the value of uPTM-FeA with the severity of acute kindey injury and diagnosis of chronic kidney disease.

Developing a Health Literacy Intervention for Immigrant Kidney Transplant Recipients

The goal of this complex interventions study is to improve health literacy (HL), medication adherence and patient education outcomes in immigrant kidney transplant recipients (KTRs). Furthermore, we aim to strengthen HL sensitivity and cultural competence in nurses providing patient education. The main questions we aims to answer are: 1. What are immigrant KTRs HL strengths and needs, medication adherence and outcomes after patient education in three important transitions following kidney transplantation: the first postoperative phase (3-7 days post-transplantation), preparing for transfer to local hospital (6-8 weeks post-transplantation), and adapting to the home context (3-6 months post-transplantation). 2. What experiences, competence and competence needs does the nurses that engage in patient education to immigrant KTRs post-transplant have? 3. Will a tailored intervention increase HL, medication adherence, and outcomes after patient education in immigrant KTXs and organizational HL and cultural competence in nurses? Qualitative methods will be used to develop and optimize the intervention. * Patients will be invited to three individual interviews in the three postoperative phases. * Nurses in three wards (surgery, medical and outpatient ward) are asked to participants in focus group interviews. * The interviews will be used to define needs and build the intervention. Ideas to the intervention will be discussed in workshops with nurses, the project group and user participants. * Parts of the intervention will be tested in the clinic followed by 'think aloud interviews' where both the nurse and the patient are asked to speak freely about their experiences using the intervention. * The intervention will be evaluated by repeating the interviews with patient and focus group interviews with nurses. * The intervention will be feasibility tested.

Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation

This is a retrospective, prospective, single-centre, non-pharmacological observational study. The primary objective is to investigate the long-term prognosis of the kidney transplant function of different types of donors.