MedTrace Logo

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

NCT00150891 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 84

Last updated 2007-05-10

No results posted yet for this study

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.

Conditions

  • Renal Failure, Chronic

Interventions

PROCEDURE

Kidney transplantation

DRUG

cyclosporine A

DRUG

tacrolimus

DRUG

azathioprine

DRUG

mycophenolate mofetil

Sponsors & Collaborators

  • Heidelberg University

    collaborator OTHER

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Fresenius AG

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Biotest

    collaborator INDUSTRY

  • University of Giessen

    lead OTHER

Principal Investigators

  • Rolf Weimer, Prof. Dr. · Department of Internal Medicine, University of Giessen, Germany

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31
Completion
2006-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00150891 on ClinicalTrials.gov