Study to evaluate the impact of donor-specific antibodies on graft function and survival after renal transplantation - Long term follow up of the SMART study populatio

Phase 1

Conditions: Renal Transplantation
MedDRA version: 18.1Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2013-004956-39-DE

Lead Sponsor: Klinikum der Universität München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients who have participated in the former SMART Trial will be included, if the give written informed consent to participate in the present study.
The main inclusion criteria into the SMART study were:
- Male end female patients between 18 and 65 years of age who were scheduled to receive renal transplantation
- first and second renal transplantation
- PRA (panel reactive antibody titers) <= 30%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Missing written informed consent
Patient do not come to the follow up visit within 3 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Long term treatment effects of a sirolimus based treatment compared to a ciclosporin based regimen shall be studied by comparing the randomized treatment groups of the former SMART-Study. The main question is whether different immunosuppressive regimens correlate with detection of donor specific antibodies in the follow up.;Secondary Objective: Are there differences in the long term follow up between different immunosuppressive regimens after renal transplantation and is there a relationship between immunusuppressive therapy and detection of donor-specific antibodies on the one and the long term transplant function/survival on the other hand.;Primary end point(s): Primary endpoint is the incidence of de novo donor-specific antibodies at the time of the current visit.;Timepoint(s) of evaluation of this end point: Median about years after transplantation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to first detection of donor-specific antibodies<br>Correlation between development of donor-specific antibodies and acute rejections<br>Status (de novo) and class and concentration of donor-specific antibodies<br>Patient and graft survival<br>biopsy proven rejections<br>first biopsy proven antibody mediated rejection<br>renal function (creatinine, calculated glomerular filtration rate)<br>switch of immunosuppressive regimen due to treatment failure<br>Frequency of new treatment related concomitant diseases<br>Serious adverse events;Timepoint(s) of evaluation of this end point: Median about 6 jears after transplantation