Th1, Th2 and Monokine Responses as Risk Factors of Renal Transplant Rejection

This study has been completed.
Sponsor:
Collaborators:
Heidelberg University
Astellas Pharma Inc
Novartis
Fresenius AG
Hoffmann-La Roche
Biotest
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT00150891
First received: September 6, 2005
Last updated: May 8, 2007
Last verified: May 2007
  Purpose

Chronic transplant rejection remains the main cause of late kidney graft loss. We showed previously that patients with pretransplant CD4 helper defects and low in-vitro IL-10 responses demonstrated an extremely low risk of acute rejection and a significantly better 1- and 3-year graft function whereas pretransplant Th1 responses were not predictive (Weimer R et al. 1996 and 1998). In liver transplant recipients, we found CD4 helper function and in-vitro IL-10 responses significantly decreased compared to CsA-treated patients (Zipperle et al. 1997). If the same effect will be demonstrated in renal transplant recipients, Tacrolimus (Tacr) treatment might result in enhanced graft survival compared to CsA, when CD4 helper function and in-vitro IL-10 responses of the individual patient are elevated. Other studies of our group suggest a beneficial role of enhanced T-suppressor activity and of an IL-6 independent B cell/monocyte defect in the maintenance of long-term stable graft function, whereas enhanced monokine secretion (TNF-a, GM-CSF, IL-6) was found in chronic rejection (Weimer et al. 1990, 1992, 1994, 1998).

In the current randomized prospective study we will analyze the impact of CsA versus Tacr and of MMF versus azathioprine on Th1, Th2 and monokine responses and their predictive value regarding occurrence of acute and chronic rejection. With a proposed follow-up of 5 years this study might enable a patient-tailored immunosuppressive therapy resulting in prolonged graft survival.


Condition Intervention
Renal Failure, Chronic
Procedure: Kidney transplantation
Drug: cyclosporine A
Drug: tacrolimus
Drug: azathioprine
Drug: mycophenolate mofetil

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Role of Th1, Th2 and Monokine Responses as Risk Factors of Acute and Chronic Renal Transplant Rejection – Impact of Different Immunosuppressive Protocols

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Enrollment: 84
Study Start Date: January 1998
Study Completion Date: January 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal transplant recipients in the Giessen renal transplant unit

Exclusion Criteria:

  • Contraindications against blood-taking (anemia with hemoglobin<9.5 g/l, hypotension etc.)
  • No informed consent by the patient
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00150891

Locations
Germany
Department of Internal Medicine, University of Giessen
Giessen, Germany, D-35392
Sponsors and Collaborators
University of Giessen
Heidelberg University
Astellas Pharma Inc
Novartis
Fresenius AG
Hoffmann-La Roche
Biotest
Investigators
Principal Investigator: Rolf Weimer, Prof. Dr. Department of Internal Medicine, University of Giessen, Germany
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00150891     History of Changes
Other Study ID Numbers: NTx-prosp-001
Study First Received: September 6, 2005
Last Updated: May 8, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Giessen:
Th1
Th2
B cell
monokines
kidney transplantation
acute rejection
chronic rejection

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Azathioprine
Cyclosporins
Cyclosporine
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on August 01, 2014