European Transplant Registry of Senior Renal Transplant Recipients on Advagraf

NCT ID: NCT02558452

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2028-01-31

Brief 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.

Detailed Description

The purpose of the registry is to establish data on the long-term outcome of elderly renal transplant recipients receiving an initial standard immunosuppression with tacrolimus once daily, mycophenolate and steroids The objectives of this registry are to investigate the long-term course of renal transplantation in the elderly European population (≥65 years) under immunosuppression with tacrolimus once daily, mycophenolate and steroids in order to better define risk factors for patient death and graft loss and predictors for favourable outcomes in this growing population.

For this purpose, the SENIOR transplant registry will be implemented to collect data on graft loss, death, renal function, quality of life and biopsy proven acute rejections (BPAR), analyze common complications such as severe infections, opportunistic infections (CMV and/or BKV viremia), malignancies, cardiovascular events, and hospitalisations in a large population of European senior renal allograft recipients. In addition, type and severity of rejections (Banff-grade, steroid resistant rejections, antibody-mediated rejections, antibody-treated rejections, recurrent rejections), development of circulating donor specific antibodies (DSA), cardiovascular risk factors (such as diabetes, development of posttransplant diabetes (PTDM), hypertension), renal function (as estimated by CKD-EPI), and proteinuria will be longitudinally assessed in parallel to immunosuppressive doses and drug levels. The registry will focus on common side effects of immunosuppressive therapy (such as leucopenia, anemia), treatment patterns and reasons for treatment changes. Finally, a prospective analysis of quality of life including the burden of medication in elderly transplant recipients is planned.

All recipients (≥65 years) of a kidney transplant who are willing to participate in the European SENIOR-Registry may enter the registry prior to transplantation if they are fulfilling all in- and none of the exclusion criteria and receive the intended initial immunosuppression consisting of tacrolimus once daily (Advagraf, initially adjusted to trough blood levels of ≥5ng/ml), mycophenolate (either ≥1.0g/day Mycophenolate Mofetil (MMF) or ≥720mg/d enteric-coated Mycophenolate Sodium (EC-MPS)) and Steroids.

There will be 12 study visits during the 10 year period. Except for quality of life questionnaires there are no study specific procedures planned. Only data will be recorded which anyway will be recorded in clinical routine.

The study population will consist of a representative group of approximately 1000 senior (≥65 years) kidney transplant patients, who receive a renal allograft and an initial standard triple immunosuppression (tacrolimus once daily (Advagraf), mycophenolate (either ≥1.0g/day Mycophenolate Mofetil (MMF) or ≥720mg/d enteric-coated Mycophenolate Sodium (EC-MPS)) and steroids. The patients will be recruited from approximately 42 transplant centers in Europe.

Conditions

Graft Failure; Death; Acute Rejection of Renal Transplant; Infections; Bone Disease; Post Transplant Diabetes Mellitus; Quality of Life; HLA Antibody Production; Cardiovascular Risk Factors; Non-HLA Antibody Production

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Tacrolimus once daily (Advagraf)

Antibody induction by antithymocyte Globulin (ATG) or Basiliximab possible but not mandatory

Intervention Type: DRUG

Other Intervention Names

mycophenolate; steroids

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. med. univ. L. J. Lehner

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

ERA-EDTA

UNKNOWN

Sponsor Role: collaborator

DESCARTES Working Group On Transplantation

OTHER

Sponsor Role: collaborator

European Kidney Transplant Association (EKITA)

OTHER

Sponsor Role: collaborator

Klemens Budde

OTHER

Sponsor Role: lead

Responsible Party

Klemens Budde

Prof. Dr. Klemens Budde

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lukas J Lehner, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Central Contacts

Lukas J Lehner, MD

Role: CONTACT

lukas.lehner@charite.de

004930450 ext. 613559

Klemens Budde, MD

Role: CONTACT

klemens.budde@charite.de

004930450 ext. 614086

Other Identifiers

SENIOR

Identifier Type: -

Identifier Source: org_study_id