Renal Transplantation
Conditions
Keywords
renal transplantation, TAIZ
Brief summary
reduce of immunsupression or introduce tolerance with so called TAIZ-monocytes in renal transplant patients
Interventions
DRUGTAIZ
Sponsors
University Hospital Schleswig-Holstein
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients must meet all the following inclusion criteria to be considered for admission to the trial: 1. Male or female adult patients aged between 18 and 64 years (inclusive). A female of childbearing potential may be enrolled provided she: * has a negative pregnancy test at Screening and * is routinely using adequate contraception prior to and during the study and * agrees not to attempt to become pregnant during the study and * is not lactating A female of non-childbearing potential will be defined as one who has been postmenopausal for at least one year or has been surgically sterilised. 2. Patients receiving a first renal transplant. 3. Patients who fulfil the criteria to receive an allogenic renal transplant (according to the Eurotransplant (ET) manual on organ allocation and the Bundesärztekammer allocation criteria) and who are listed on a waiting list. 4. Patients who, after the nature of the study and the disclosure of their data has been explained to them, have freely given Informed Consent in writing. 5. In vitro demonstration of the suppressive effect of the donor TAIC for the donor-recipient pair.
Exclusion criteria
(for the recipient)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| graft survival and reduction or withdrawal of immunosuppressives after treatment with Transplant-Acceptance Inducing Cells (TAIC) and autologous regulatory T cells (tregs) | — |
| serum creatinine | — |
| rejection episodes | — |
| necessity for re-introduction of any immunosuppressives. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability of the treatment with Transplant-Acceptance Inducing Cells (TAIC) in terms of rejection episodes and Adverse Events (AEs) | — |
Countries
Germany
Contacts
Primary ContactUlrich Kunzendorf
Outcome results
None listed