TAIZ -Monocytes for the Induction of Donor Specific Tolerance in Renal Allograft Recipients (Cadaver Kidney)

A Single-Center Open-Labelled Study of the Administration of Transplant-Acceptance Inducing Cells (TAIZ) for the Induction of Donor Specific Tolerance in Renal Allograft Recipients (Cadaver Kidney)

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00223093

Enrollment

Registered

2005-09-22

Start date

2004-02-29

Completion date

2005-08-31

Last updated

2005-10-28

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

Conditions

Renal Transplantation

Keywords

renal transplantation, TAIZ-moncytes

Brief summary

Induce tolerance or reduce the amount of immunosuppression after renal transplant patient (receiving cadaver kidney)with so called TAIZ-monocytes

Interventions

DRUGTAIZ

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

Inclusion criteria

4.3.1 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 allogeneic renal transplant from a cadaver (according to the Eurotransplant (ET) manual on organ allocation and the Bundesärztekammer allocation criteria). 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. 4.3.2

Exclusion criteria

Patients presenting any of the following

Design outcomes

Primary

Measure	Time frame
graft survival	—
replacement of immunosuppressives after treatment with Transplant-Acceptance Inducing Cells (TAIC)	—
serum creatinine	—
rejection episodes	—
re-introduction of immunosuppressives.	—

Secondary

Measure	Time frame
safety and tolerability of the treatment with Transplant-Acceptance Inducing Cells (TAIC) Adverse Events (AEs)	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026