European Transplant Registry of Senior Renal Transplant Recipients on Advagraf

Launched by KLEMENS BUDDE · Sep 22, 2015

Keywords

ClinConnect Summary

The European Transplant Registry is a study aimed at understanding the long-term outcomes of kidney transplant patients aged 65 and older who are receiving specific medications to help prevent their body from rejecting the new kidney. This study will look at various important health aspects, such as the risk of kidney failure, infections, and overall quality of life. The trial is not yet recruiting participants, but it plans to enroll elderly patients who have received a kidney transplant from a compatible donor and are willing to participate.

To be eligible for this study, participants must be at least 65 years old, have received a kidney transplant, and be on a standard medication regimen that includes tacrolimus (a drug that helps prevent organ rejection), mycophenolate, and steroids. They should also have low to standard immunological risk, meaning their body is less likely to reject the new kidney. Participants can expect to provide their consent and will be observed over time to gather valuable information about their health and transplant outcomes. This study is important as it focuses on a specific age group that may face unique challenges after a kidney transplant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males or females, aged ≥65 years
• • Patients who received a renal allograft
• • Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
• • Patients on an intended standard triple therapy with tacrolimus once daily (Advagraf with trough level ≥5ng/ml) in combination with mycophenolate (either ≥1.0g/day MMF or ≥720mg/d EC-MPS) and Steroids (≥5mg prednisolone or equivalent)
• • Patient must have received primary or secondary renal allograft from a blood group compatible donor (either deceased or living)
• • Patients with low to standard immunological risk, who had a PRA 20% (PRA testing according to center's practice) or no known donor specific antibodies at transplantation
• Exclusion Criteria:
• • Multi-organ recipients (solid organ or bone marrow)
• • More than secondary renal allograft recipients
• • Blood group A,B,O-incompatible allografts
• • Documented presence of donor specific antibodies (DSA)
• • Panel reactive antibody (PRA) \>20% prior to transplantation (PRA testing according to center's practice)
• • Patients having received any other induction therapy than Basiliximab or depleting polyclonal antithymocyte antibodies (ATG) (e.g. OKT3, Campath)
• • Patients receiving Sirolimus, Everolimus, Azathioprine, Belatacept or Cyclophosphamide within 3 months prior to or at enrolment
• • History of alcohol or drug abuse with less than 6 months of sobriety
• • Patient with any condition that may affect absorption of immunosuppressives, (e.g. severe diarrhoea, gastrectomy, active peptic ulcer disease or clinically significant diabetic gastroenteropathy) or tacrolimus metabolism (e.g. liver cirrhosis)
• • Patient with mental dysfunction or inability to cooperate within the study
• • Patients who have been institutionalized by official or court order