An observational study in Graft Failure, Death and Acute Rejection of Renal Transplant, sponsored by Klemens Budde. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-08-12.
Sponsored by Klemens Budde · Observational
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.
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.
456 studies on the registry are indexed under Death; 86 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 400 across 236 observational studies indexed under Death.
Browse Death studies →Klemens Budde is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Antibody induction by antithymocyte Globulin (ATG) or Basiliximab possible but not mandatory
Also known as: mycophenolate, steroids
Patient survival
Time frame: From date of transplantation until the date of death from any cause, assessed up to 10 years
Renal graft survival
Time frame: 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 frame: 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 frame: 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
Time frame: 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 frame: 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 frame: 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
Incidence of kidney biopsies and suspected rejections
Incidence (number) of kidney biopsies and suspected rejections
Time frame: from time of transplantation for up to 10 years
Stroke
number and type of events
Time frame: from time of transplantation up to 10 years
Coronary revascularization procedure
number and type of events
Time frame: from time of transplantation up to 10 years
Carotid surgery
number and type of events
Time frame: from time of transplantation up to 10 years
Revascularisation procedures for symptomatic peripheral artery disease
number and type of events
Time frame: from time of transplantation up to 10 years
Symptomatic peripheral artery disease
number and type of Events, classification by Fontaine
Time frame: from time of transplantation up to 10 years
cardiac death
number and type of events
Time frame: 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
Time frame: 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
Time frame: from time of transplantation up to 10 years
Infections in general
Incidence of infections and type of infections
Time frame: from time of transplantation up to 10 years
Cytomegalovirus (CMV) disease
Incidence, defined by symptomatic CMV infection (including pulmonary and intestinal infections)
Time frame: from time of transplantation up to 10 years
CMV infection
Incidence, Defined by nucleic acid testing (NAT) in blood
Time frame: from time of transplantation up to 10 years
BKV (BK-Virus) infection
Incidence; Def: NAT testing in urine and blood or by biopsy staining
Time frame: from time of transplantation up to 10 years
Pneumocystis jiroveci pneumonia infection
Incidence
Time frame: from time of transplantation up to 10 years
Malignancies
Incidence, types of malignancies
Time frame: from time of transplantation up to 10 years
Post transplant diabetes mellitus
Incidence and time to development of posttransplant diabetes mellitus (PTDM)
Time frame: from time of transplantation up to 10 years
Immunosuppressants
Type of IS, Changes of IS
Time frame: from time of transplantation up to 10 years
Bone disease
number of fractures, measured height (meters)
Time frame: from time of transplantation up to 10 years
Quality of life measures
Quality of life by questionnaire (SF36, MTSODS)
Time frame: from time of transplantation up to 10 years
No study locations are listed for this record.
Plan to share: Yes — aggregated data are available through the Steering committee of DESCARTES and EKITA
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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