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The impact of immunosuppressives on age-related changes of the immune system after kidney transplantation

The role of immunosuppressives in immunosenescence and immunotolerance in renal transplantation - Immunosuppressives and immunosenescence

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003604-21-AT
Enrollment
Unknown
Registered
2011-09-19
Start date
2011-10-24
Completion date
Unknown
Last updated
2015-07-10

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

Conditions

The impact of immunosuppressives on age-related changes of the immune system will be analyzed in patients after renal transplantation. Only patients at least one year after renal tranplantation and with stable condition of the transplant will be included. Healthy adults without immunosuppressive therapy will be included as controls. Age of participants will range from 18-80 years. MedDRA version: 14.0 Level: PT Classification code 10062016 Term: Immunosuppression System Organ Class: 10021428 -

Interventions

Trade Name: Certican Product Name: Certican Pharmaceutical Form: Tablet Trade Name: Rapamune Product Name: Rapamune Pharmaceutical Form: Coated tablet Trade Name: Sandimmun Neoral Product Name: Sand

Sponsors

Universitätsklinik für Innere Medizin IV, Medizinische Universität Innsbruck
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients after renal transplantation: - transplantation more than 1 year ago - current therapy is Tacrolimus, Cyclosporin A or Sirolimus/Everolimus - signed informed consent form healthy controls: - signed informed consent form 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: patients after renal transplantation: - acute or chronic rejection - dysfunction of the transplant healthy controls: - immunosuppressive therapy - chronic infection with HBV, HCV or HIV - chemotherapy - pregnant women

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s): Determination of immunological parameters (T cell subpopulations, antigen-specific T cells, T cell repertoire)—

Countries

Austria

Contacts

Public ContactGert Mayer

Universitätsklinik für Innere Medizin IV, Medizinische Universität Innsbruck

gert.mayer@i-med.ac.at+4351250425885

Outcome results

None listed

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