European Transplant Registry of Senior Renal Transplant Recipients on Advagraf

• Status: Not yet recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

Summary

SENIOR transplant Registry European transplant registry of senior renal transplant recipients (above the age of 65 years) receiving initial immunosuppression with tacrolimus once daily, mycophenolate and steroids to investigate long term outcomes on an observational basis.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Klemens Budde
• Collaborators: Charite University, Berlin, Germany; DESCARTES Working Group On Transplantation; Dr. med. univ. L. J. Lehner; EKITA (European Kidney Transplant Association); ERA-EDTA; European Kidney Transplant Association (EKITA); Koordinierungszentrum Klinischer Studie der Charite Berlin (KKS Berlin)
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

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