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 population

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004956-39-DE

Enrollment

Unknown

Registered

2014-05-06

Start date

2014-06-18

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation MedDRA version: 18.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865

Interventions

Trade Name: Rapamune Product Name: Sirolimus Pharmaceutical Form: Coated tablet INN or Proposed INN: SIROLIMUS CAS Number: 53123-88-9 Concentration unit: mg milligram(s) Concentration type: range Conc

Eligibility

Sex/Gender

All

Inclusion criteria

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) =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactKCS Chirurgie

Klinik für Allgemeine, Viszeral-, Transplantations-, Gefäß- und Thoraxchirurgie

kcs@med.uni-muenchen.de0049(0)8970950

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026