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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150891
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : May 10, 2007
Heidelberg University
Astellas Pharma Inc
Fresenius AG
Hoffmann-La Roche
Information provided by:
University of Giessen

Brief Summary:

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 or disease Intervention/treatment
Renal Failure, Chronic Procedure: Kidney transplantation Drug: cyclosporine A Drug: tacrolimus Drug: azathioprine Drug: mycophenolate mofetil

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Role of Th1, Th2 and Monokine Responses as Risk Factors of Acute and Chronic Renal Transplant Rejection – Impact of Different Immunosuppressive Protocols
Study Start Date : January 1998
Actual Study Completion Date : January 2006

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150891

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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
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Principal Investigator: Rolf Weimer, Prof. Dr. Department of Internal Medicine, University of Giessen, Germany

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00150891     History of Changes
Other Study ID Numbers: NTx-prosp-001
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: May 10, 2007
Last Verified: May 2007
Keywords provided by University of Giessen:
B cell
kidney transplantation
acute rejection
chronic rejection
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites, Antineoplastic