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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00223093
Recruitment Status : Unknown
Verified April 2003 by University Hospital Schleswig-Holstein.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : October 28, 2005
Information provided by:
University Hospital Schleswig-Holstein

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

Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: TAIZ Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : February 2004
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. graft survival
  2. replacement of immunosuppressives after treatment with Transplant-Acceptance Inducing Cells (TAIC)
  3. serum creatinine
  4. rejection episodes
  5. re-introduction of immunosuppressives.

Secondary Outcome Measures :
  1. safety and tolerability of the treatment with Transplant-Acceptance Inducing Cells (TAIC) Adverse Events (AEs)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 exclusion criteria must not be included in the trial:

  1. Patients who have received a renal transplant.
  2. Patients who have an active infection at the time of entry into the study (Screening).
  3. Recipient and donor pairs who show the following incompatible CMV constellation: the donor is CMV positive and the recipient is CMV negative.
  4. Patients and donor who have positive evidence of HIV or have active virus hepatitis B and C.
  5. Patients with a history of alcohol and/or drug abuse.
  6. Patients who are pregnant women or nursing mothers.
  7. Known hypersensitivity or contraindication to one of the immunosuppressives administered during the course of the study: tacrolimus, sirolimus or steroids (prednisolone and methylprednisolone).
  8. Patients with a history or present symptoms of autoimmune vasculitis.
  9. Detection of >5% HLA antibodies (current values determined during the last three months).
  10. Patients with a malignancy or history of malignancy.
  11. Patients with renal insufficiency due to a vasculitis.
  12. Recipient and donor pairs with complete HLA matching.
  13. Patients whose condition requires continuous systemic steroid administration.
  14. Patients who are simultaneously participating or plan to participate in any other clinical study.
  15. Psychiatric or emotional problems or lack of knowledge of the German language which would invalidate the giving of Informed Consent or limit the ability of the subject to comply with study requirements.
  16. Unwillingness or inability to provide Informed Consent or to participate satisfactorily for the entire trial period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00223093

Sponsors and Collaborators
University Hospital Schleswig-Holstein
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Principal Investigator: Ulrich Kunzendorf, MD University of Schleswig-Holstein, Campus Kiel Department of Nephrolgy
Layout table for additonal information Identifier: NCT00223093    
Other Study ID Numbers: 006
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 28, 2005
Last Verified: April 2003
Keywords provided by University Hospital Schleswig-Holstein:
renal transplantation, TAIZ-moncytes
Additional relevant MeSH terms:
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Pathologic Processes