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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2003 by University of Schleswig-Holstein.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00223093
First received: September 14, 2005
Last updated: October 27, 2005
Last verified: April 2003
  Purpose

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


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 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)

Resource links provided by NLM:


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

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

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

Estimated Enrollment: 10
Study Start Date: February 2004
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223093

Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Ulrich Kunzendorf, MD University of Schleswig-Holstein, Campus Kiel Department of Nephrolgy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00223093     History of Changes
Other Study ID Numbers: 006
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-moncytes

ClinicalTrials.gov processed this record on August 19, 2014