Changes in the immune status (information on the status of the immune system)bei nierentransplantierten Patienten after switch to the immunosuppressive (suppression of immunological processes) therapy on the mTOR inhibitor everolimus (medication which prevent rejection following organ transplantation). An open-label (knowledge of the assigned treatment), non-randomized (no random allocation to treatment groups), single center (contacted in one study center) study.

Changes of cytokines and regulatory T cells in renal transplant recipients after switch to the mTOR inhibitor Everolimus. A Single center trial, non-blinded, non-randomized. - Immunological changes due to mTORi

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004856-12-AT

Enrollment

Registered

2013-02-12

Start date

2013-03-12

Completion date

Unknown

Last updated

2024-02-19

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

Conditions

organ transplant MedDRA version: 15.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 100000004865

Interventions

Trade Name: Certican 0,25mg Tabletten Product Name: Certican Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus CAS Number: 159351-69-6 Other descriptive name: EVEROLIMUS Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Kidney transplant recipients • First kidney transplantation • Aged between 18-70 years • At risk for CMV infection (donor CMV IgG positive) • Written informed consent before entry into the study 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • Re-transplantation • Living Donor Transplantation • Known intolerance to substance (everolimus) • Participation in any other study

Design outcomes

Primary

Measure	Time frame
Main Objective: Changes of cytokines in renal transplant recipients after switch of immunosuppression from CNI (calcineurin inhibitor) to the mTORi (mTOR inhibitor) Certican.;Secondary Objective: Changes of regulatory T cell numbers and function in renal transplant recipients after switch of immunosuppression from CNI to the mTORi Certican.;Primary end point(s): * Cytokine changes after switch to Everolimus-based immunosuppression * Regulatory T cell status after switch to Everolimus-based immunosuppression ;Timepoint(s) of evaluation of this end point: Evaluation of cytokine profile an regulatory T cell function before start of Certican, week 1, week 4 and week 8 after changing immunosuppression. Cytokine levels will be measured in T-Cells at the 4 visits.	—

Measure

Time frame

Main Objective: Changes of cytokines in renal transplant recipients after switch of immunosuppression from CNI (calcineurin inhibitor) to the mTORi (mTOR inhibitor) Certican.;Secondary Objective: Changes of regulatory T cell numbers and function in renal transplant recipients after switch of immunosuppression from CNI to the mTORi Certican.;Primary end point(s): * Cytokine changes after switch to Everolimus-based immunosuppression * Regulatory T cell status after switch to Everolimus-based immunosuppression ;Timepoint(s) of evaluation of this end point: Evaluation of cytokine profile an regulatory T cell function before start of Certican, week 1, week 4 and week 8 after changing immunosuppression. Cytokine levels will be measured in T-Cells at the 4 visits.

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Secondary

Measure	Time frame
Secondary end point(s): * Incidence of CMV-infection after switch to Everolimus-based immunosuppression * Incidence of acute rejection after switch to Everolimus-based immunosuppression ;Timepoint(s) of evaluation of this end point: At week 0, week 1, week 4 and week 8 lymphocytes will be isolated and evaluated by flow cytometry for their Treg content. Blood cell count, renal function, liver function, electolytes, CRP and drug level of the immunosuppressants will be evaluated at every visit.	—

Measure

Time frame

Secondary end point(s): * Incidence of CMV-infection after switch to Everolimus-based immunosuppression * Incidence of acute rejection after switch to Everolimus-based immunosuppression ;Timepoint(s) of evaluation of this end point: At week 0, week 1, week 4 and week 8 lymphocytes will be isolated and evaluated by flow cytometry for their Treg content. Blood cell count, renal function, liver function, electolytes, CRP and drug level of the immunosuppressants will be evaluated at every visit.

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Countries

Austria

Contacts

Public ContactKlinische Abteilung für Nephrologie

Medical University of Graz

kks@medunigraz.at4331638512170

Outcome results

None listed

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