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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02558452
Other study ID # SENIOR
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 19, 2015
Last updated August 11, 2016
Start date December 2016
Est. completion date January 2028

Study information

Verified date August 2016
Source Charite University, Berlin, Germany
Contact Lukas J Lehner, MD
Phone 004930450
Email lukas.lehner@charite.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date January 2028
Est. primary completion date January 2027
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Tacrolimus once daily (Advagraf)
Antibody induction by antithymocyte Globulin (ATG) or Basiliximab possible but not mandatory

Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
Klemens Budde DESCARTES working group on transplantation, Dr. med. univ. L. J. Lehner, EKITA (European Kidney Transplant Association), ERA-EDTA, Koordinierungszentrum Klinischer Studie der Charite Berlin (KKS Berlin)

Outcome

Type Measure Description Time frame Safety issue
Primary Patient survival From date of transplantation until the date of death from any cause, assessed up to 10 years No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Incidence of kidney biopsies and suspected rejections Incidence (number) of kidney biopsies and suspected rejections from time of transplantation for up to 10 years No
Secondary Stroke number and type of events from time of transplantation up to 10 years No
Secondary Coronary revascularization procedure number and type of events from time of transplantation up to 10 years No
Secondary Carotid surgery number and type of events from time of transplantation up to 10 years No
Secondary Revascularisation procedures for symptomatic peripheral artery disease number and type of events from time of transplantation up to 10 years No
Secondary Symptomatic peripheral artery disease number and type of Events, classification by Fontaine from time of transplantation up to 10 years No
Secondary cardiac death number and type of events from time of transplantation to the date of the event for up to 10 years, whichever comes first No
Secondary non-fatal myocardial infarction number and type of events from time of transplantation to the date of the event for up to 10 years, whichever comes first No
Secondary Hospitalisations Incidence of hospitalisations, reasons and length of hospitalisations from time of transplantation up to 10 years No
Secondary Infections in general Incidence of infections and type of infections from time of transplantation up to 10 years No
Secondary Cytomegalovirus (CMV) disease Incidence, defined by symptomatic CMV infection (including pulmonary and intestinal infections) from time of transplantation up to 10 years No
Secondary CMV infection Incidence, Defined by nucleic acid testing (NAT) in blood from time of transplantation up to 10 years No
Secondary BKV (BK-Virus) infection Incidence; Def: NAT testing in urine and blood or by biopsy staining from time of transplantation up to 10 years No
Secondary Pneumocystis jiroveci pneumonia infection Incidence from time of transplantation up to 10 years No
Secondary Malignancies Incidence, types of malignancies from time of transplantation up to 10 years No
Secondary Post transplant diabetes mellitus Incidence and time to development of posttransplant diabetes mellitus (PTDM) from time of transplantation up to 10 years No
Secondary Immunosuppressants Type of IS, Changes of IS from time of transplantation up to 10 years No
Secondary Bone disease number of fractures, measured height (meters) from time of transplantation up to 10 years No
Secondary Quality of life measures Quality of life by questionnaire (SF36, MTSODS) from time of transplantation up to 10 years No
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