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

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

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

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
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Please refer to this study by its identifier: NCT00150891

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


Publications automatically indexed to this study by Identifier (NCT Number): 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:
B cell
kidney transplantation
acute rejection
chronic rejection

Additional relevant MeSH terms:
Kidney Failure, Chronic
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 30, 2016