European Transplant Registry of Senior Renal Transplant Recipients on Advagraf

NCT02558452 | Not Yet Recruiting

• 1 other identifier: SENIOR
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

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

Keywords

elderly kidney transplant recipient; registry; tacrolimus once daily

Outcome Measures

Primary Outcomes (7)

• Patient survival

  From date of transplantation until the date of death from any cause, assessed up to 10 years

• Renal graft survival

  From date of transplantation until the date of documented graft failure (need for permanent dialysis, explantation of the graft, retransplantation) or date of death from any cause, whichever came first, assessed up to 10 years

• Biopsy proven acute rejection (BPAR)

  Type of rejection according to BANFF 2013 classification

  Time of transplantation to date of first BPAR and consecutive BPARs, assessed up to 10 years

• Development of anti-HLA antibodies

  type of antibodies (by HLA class and specificity), outcome after antibody production

  Time of transplantation to date of first detection of any HLA antibodies, assesments are month 3 and year 1,3,5,7 and 10 in the central laboratory and all in all up to 10 years locally

• Renal graft function by estimated glomerular Filtration rate (eGFR) by CKD-EPI) calculation

  Change of creatinine from baseline to the discrete observational visits, Calculation of eGFR (CKD-EPI) and eGFR slope

  Assesment of renal graft function over time up to 10 years or graft failure or death, whichever comes first

• Development of non-HLA antibodies

  type of antibodies, outcome after antibody production

  Time of transplantation to date of first detection of any HLA antibodies, assesments are month 3 and year 1,3,5,7 and 10 in the central laboratory and all in all up to 10 years locally

• Development of donor specific antibodies (DSA)

  type of antibodies (by HLA class and specificity), outcome after antibody production

  Time of transplantation to date of first detection of any HLA antibodies, assesments are month 3 and year 1,3,5,7 and 10 in the central laboratory and all in all up to 10 years locally

Secondary Outcomes (19)

• Incidence of kidney biopsies and suspected rejections

  from time of transplantation for up to 10 years

• Stroke

  from time of transplantation up to 10 years

• Coronary revascularization procedure

  from time of transplantation up to 10 years

• Carotid surgery

  from time of transplantation up to 10 years

• Revascularisation procedures for symptomatic peripheral artery disease

  from time of transplantation up to 10 years

Interventions

Tacrolimus once daily (Advagraf) DRUG

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

Also known as: mycophenolate, steroids

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klemens Budde: lead
• Dr. med. univ. L. J. Lehner: collaborator
• Charite University, Berlin, Germany: collaborator
• ERA-EDTA: collaborator
• DESCARTES Working Group On Transplantation: collaborator
• European Kidney Transplant Association (EKITA): collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

HLA antibodies, Non HLA antibodies

MeSH Terms

Conditions

Death; Infections; Bone Diseases

Interventions

Mycophenolic Acid; Steroids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lukas J Lehner, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas J Lehner, MD

CONTACT

004930450; lukas.lehner@charite.de

Klemens Budde, MD

CONTACT

004930450; klemens.budde@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Klemens Budde

Study Record Dates

• First Submitted: September 19, 2015
• First Posted: September 24, 2015
• Study Start: December 1, 2016
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 12, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share