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European Transplant Registry of Senior Renal Transplant Recipients on Advagraf

ConditionsGraft FailureDeathAcute Rejection of Renal TransplantInfectionsBone DiseasePost Transplant Diabetes MellitusQuality of LifeHLA Antibody ProductionCardiovascular Risk FactorsNon-HLA Antibody Production
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorKlemens Budde

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tacrolimus once daily (Advagraf)

    Drug

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Patient survival

Time frame
From date of transplantation until the date of death from any cause, assessed up to 10 years
2

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
3

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
4

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

Secondary outcomes

1

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
2

Stroke

number and type of events

Time frame
from time of transplantation up to 10 years
3

Coronary revascularization procedure

number and type of events

Time frame
from time of transplantation up to 10 years
4

Carotid surgery

number and type of events

Time frame
from time of transplantation up to 10 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Klemens Budde

Lead sponsor

Charite University, Berlin, Germany

Sponsor institution

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: