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.

Phase 1

• Conditions: organ transplant; MedDRA version: 15.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-004856-12-AT
• Lead Sponsor: Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-12
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified