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.|
|ClinicalTrials.gov Identifier: NCT00150891|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : May 10, 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 or disease||Intervention/treatment|
|Renal Failure, Chronic||Procedure: Kidney transplantation Drug: cyclosporine A Drug: tacrolimus Drug: azathioprine Drug: mycophenolate mofetil|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||84 participants|
|Observational Model:||Defined Population|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT00150891
|Department of Internal Medicine, University of Giessen|
|Giessen, Germany, D-35392|
|Principal Investigator:||Rolf Weimer, Prof. Dr.||Department of Internal Medicine, University of Giessen, Germany|