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

Renal Transplantation Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00223093
• Other study ID #: 006
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 14, 2005
• Last updated: October 27, 2005
• Start date: February 2004
• Est. completion date: August 2005

Study information

• Verified date: April 2003
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• TAIZ

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	graft survival
Primary	replacement of immunosuppressives after treatment with Transplant-Acceptance Inducing Cells (TAIC)
Primary	serum creatinine
Primary	rejection episodes
Primary	re-introduction of immunosuppressives.
Secondary	safety and tolerability of the treatment with Transplant-Acceptance Inducing Cells (TAIC) Adverse Events (AEs)