Graft FailureSENIORNCT02558452
European Transplant Registry of Senior Renal Transplant Recipients on Advagraf
An observational study of Graft Failure and Death, run by Klemens Budde.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Graft Failure, Death, Acute Rejection of Renal Transplant
- What is being tested?
- Tacrolimus once daily (Advagraf)
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jan 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: European Transplant Registry of Senior Renal Transplant Recipients Receiving Initial Immunosuppression With Tacrolimus Once Daily, Mycophenolate and Steroids
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.
Read the 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
- Being tested
- Tacrolimus once daily (Advagraf)
- Keywords
- elderly kidney transplant recipient, registry, tacrolimus once daily
- Medical subject headings
- Death, Infections, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus once daily (Advagraf)Drug
Also called mycophenolate, steroids
Antibody induction by antithymocyte Globulin (ATG) or Basiliximab possible but not mandatory
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Measured: From date of transplantation until the date of death from any cause, assessed up to 10 years
Renal graft survival
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Incidence (number) of kidney biopsies and suspected rejections
Measured: from time of transplantation for up to 10 years
Stroke
number and type of events
Measured: from time of transplantation up to 10 years
Coronary revascularization procedure
number and type of events
Measured: from time of transplantation up to 10 years
Carotid surgery
number and type of events
Measured: from time of transplantation up to 10 years
Revascularisation procedures for symptomatic peripheral artery disease
number and type of events
Measured: from time of transplantation up to 10 years
Symptomatic peripheral artery disease
number and type of Events, classification by Fontaine
Measured: from time of transplantation up to 10 years
cardiac death
number and type of events
Measured: from time of transplantation to the date of the event for up to 10 years, whichever comes first
non-fatal myocardial infarction
number and type of events
Measured: from time of transplantation to the date of the event for up to 10 years, whichever comes first
Hospitalisations
Incidence of hospitalisations, reasons and length of hospitalisations
Measured: from time of transplantation up to 10 years
Infections in general
Incidence of infections and type of infections
Measured: from time of transplantation up to 10 years
Cytomegalovirus (CMV) disease
Incidence, defined by symptomatic CMV infection (including pulmonary and intestinal infections)
Measured: from time of transplantation up to 10 years
CMV infection
Incidence, Defined by nucleic acid testing (NAT) in blood
Measured: from time of transplantation up to 10 years
BKV (BK-Virus) infection
Incidence; Def: NAT testing in urine and blood or by biopsy staining
Measured: from time of transplantation up to 10 years
Pneumocystis jiroveci pneumonia infection
Incidence
Measured: from time of transplantation up to 10 years
Malignancies
Incidence, types of malignancies
Measured: from time of transplantation up to 10 years
Post transplant diabetes mellitus
Incidence and time to development of posttransplant diabetes mellitus (PTDM)
Measured: from time of transplantation up to 10 years
Immunosuppressants
Type of IS, Changes of IS
Measured: from time of transplantation up to 10 years
Bone disease
number of fractures, measured height (meters)
Measured: from time of transplantation up to 10 years
Quality of life measures
Quality of life by questionnaire (SF36, MTSODS)
Measured: from time of transplantation up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startDec 2016
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Klemens Budde
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. med. univ. L. J. Lehner, Charite University, Berlin, Germany, ERA-EDTA, DESCARTES Working Group On Transplantation, European Kidney Transplant Association (EKITA)
- Responsible party
- Sponsor-investigator, Klemens Budde, Charite University, Berlin, Germany
- Investigators
- Lukas J Lehner, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558452
- Sponsor's protocol ID
- SENIOR
- Acronym
- SENIOR
- Status last verified
- Aug 2016
- First submitted
- 19 Sep 2015
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: aggregated data are available through the Steering committee of DESCARTES and EKITA