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The Differential Effects of 3 Different Immunosuppressive

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Northwestern University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00729248
First received: August 4, 2008
Last updated: February 3, 2009
Last verified: February 2009
History of Changes
  Purpose

The study is a laboratory investigation comparing the regulatory effects of different immunosuppressive therapies in an in vitro human MLR assay of selecting specific immunosuppressive therapy to promote a regulatory profile and determining possibly newer accepted dosing and drug concentrations for agents most associated with this regulatory profile.


Condition
Immunosuppression
Kidney Transplantation

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Differential Effects of 3 Different Immunosuppressive Agents, Tacrolimus Mycophenolate Mofetil and Sirolimus on the Generation of Tregs and DCregs in in Vitro MLR and T Cell Activation Assays

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • To Examine the regulatory effects of three IS agents (TAC, MMF, SRL) in an in vitro human model (MLR and Anti-CD3 T cell activation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To determine differences in the effects of various IS doses and drug levels on the generation of regulatory profiles in this model [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

White Cells.


Estimated Enrollment: 12
Study Start Date: July 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Life-long immunosuppressive (IS) therapy is typically required in the great majority of organ transplants. Immunobiologically correct IS dosing, tapering to low levels and/or monotherapy could lower the incidence of complications related to IS and improve long term graft and patient survival. The current standard of IS care for liver transplant recipients are the calcineurin-inhibitors (CNIs) tacrolimus (TAC) and cyclosporine (CSA), although alternative IS drugs such as mycophenolate mofetil (MMF) and sirolimus (SRL) are available for use in select patients. This is also true for kidney, pancreas and heart transplant recipients, with TAC being favored in each case. The ideal IS agent is one that can be given at low levels such that both rejection and long term toxicity are minimized. Directly related to IS minimization might be the development of a regulatory, "tolerance profile", as assessed by ex vivo immunophenotyping and functional assays that might test these specific IS agents singly, in combination or even in sequence.

Human Tregs and DCregs can be more predominantly generated in the presence of one of three IS agents with different modes of action, i.e., TAC, MMF or SRL, and in different conditions of antigen presentation and alloimmune incompatibility.

This is a bench protocol studying the effects of TAC, MMF and SRL on pre operative living renal recipient donor pair.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Six to Twelve preoperative renal transplant living donor pairs.

Criteria

Inclusion Criteria:

  • Adults 18 years of Age or Older
  • Undergoing living donor renal transplant

Exclusion Criteria:

  • No active infection or history of malignancy
  • No HIV infection
  • No Hepatitis C (HCV) infection
  • No prior transplant (kidney or other organ)
  • No chromic use of immunosuppressive therapy or history of autoimmune disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729248

Contacts
Contact: Amna Daud, MPH 312-503-1930 a-daud@northwestern.edu
Contact: Lorenzo Gallon, MD 312-695-4457 l-gallon@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Lorenzo Gallon, MD            
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Lorenzo Gallon, MD Northwestern University
  More Information

No publications provided

Responsible Party: Karen Vandeputte, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier: NCT00729248     History of Changes
Other Study ID Numbers: KV-08-001
Study First Received: August 4, 2008
Last Updated: February 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Transplants
Kidney Transplantation
Immunosuppression
Assay
Graft Rejection

Additional relevant MeSH terms:
Immunosuppressive Agents
Mycophenolate mofetil
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013