Induction of Donor-Specific Tolerance in Renal Allograft Recipients (Living Donor) With TAIZ-Monocytes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by University of Schleswig-Holstein.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00223067
First received: September 14, 2005
Last updated: October 27, 2005
Last verified: April 2004
  Purpose

reduce of immunsupression or introduce tolerance with so called TAIZ-monocytes in renal transplant patients


Condition Intervention Phase
Renal Transplantation
Drug: TAIZ
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Open-Labeled Study of the Administration of Allogenic and Autologous Regulatory Cells for the Induction of Donor-Specific Tolerance in Renal Allograft Recipients (Living Donor)

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • safety and tolerability of the treatment with Transplant-Acceptance Inducing Cells (TAIC) in terms of rejection episodes and Adverse Events (AEs)

Estimated Enrollment: 10
Study Start Date: March 2005
Estimated Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

Exclusion Criteria (for the recipient):

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 EBV or CMV constellation: the donor is EBV or CMV positive and the recipient is EBV or CMV negative.
  4. Patients and/or donors 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 or sepsis.
  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: ATG, tacrolimus, or steroids (prednisolone).
  8. Patients with a history or present symptoms of autoimmune vasculitis.
  9. Detection of > 5% HLA antibodies (all current and historic values).
  10. Patients with a malignancy or history of malignancy.
  11. Patients with renal insufficiency due to a vasculitis.
  12. Patients whose condition requires continuous systemic administration of immunosuppressives.
  13. Missing immunosuppressive effect of the donor TAIC for the donor-recipient pair in vitro test.
  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
  17. Patients with corresponding donors presenting any one of the exclusion criteria documented in the Eurotransplant guidelines ( ) must not be included in the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223067

Contacts
Contact: Ulrich Kunzendorf 004315971338 kunzendorf@nephro.uni-kiel.de

Locations
Germany
University of Schleswig-Holstein, Campus Kiel, Department of Nephrology Recruiting
Kiel, Germany, 24105
Contact: Ulrich Kunzendorf, MD    004315971338    Kunzendorf@nephro.uni-kiel.de   
Sub-Investigator: Lutz Renders, MD         
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Ulrich Kunzendorf, MD University of Schleswig-Holstein, Campus Kiel Department of Nephrology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00223067     History of Changes
Other Study ID Numbers: 005
Study First Received: September 14, 2005
Last Updated: October 27, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:
renal transplantation
TAIZ

ClinicalTrials.gov processed this record on April 17, 2014