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Studies of Kidney Transplant Outcome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01277770
First received: August 19, 2010
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to improve outcome for kidney transplant recipients. There has not been commensurate improvement in medium and long-term outcomes. Ongoing clinical research is necessary to improve transplant outcomes.


Condition Intervention
Transplant Recipient (Kidney)
Steroid-Free Maintenance Immunosuppression
Post-Transplant Infections
Thymoglobulin
Drug: Steroid-Free Maintenance Immunosuppression
Other: Infection After Kidney Transplantation
Drug: Evaluation of the DGF nomogram in Thymoglobulin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Studies of Kidney Transplant Outcome

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Data Analysis [ Time Frame: 10 year followup ] [ Designated as safety issue: No ]
    All studies are analyses from the Transplant Outcomes Database. Recipients have signed consent to have medical information entered into the database for these analyses. The database contains information on short, medium and long-term results.


Estimated Enrollment: 7500
Study Start Date: May 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Kidney Transplant Recipients
Kidney Transplant Recipients at the University of Minnesota since 1984. The study looks at a 10 year followup of steroid-free maintenance immunosuppression, post-transplant infections and evaluation of the DGF nomogram in Thymoglobulin on patients at the University of Minnesota.
Drug: Steroid-Free Maintenance Immunosuppression
10 year follow-up of steroid-free maintenance immunosuppression
Other Names:
  • Steroid-Free
  • Immunosuppression
Other: Infection After Kidney Transplantation
A cross-sectional study of infection after kidney transplantation (with emphasis on infection in steroid-free recipients).
Other Names:
  • Infection
  • Transplantation
  • Steroid-Free
Drug: Evaluation of the DGF nomogram in Thymoglobulin
An evaluation of the DGF nomogram in Thymoglobulin treated recipients at the University of Minnesota
Other Name: Thymoglobulin

Detailed Description:

This study is looking at information already collected of transplant outcomes (short, medium and long-term complications and quality of life). This will specifically look at:

  1. 10 year follow-up of steroid-free maintenance immunosuppression
  2. A cross-sectional study of infection after kidney transplantation (with emphasis on infection in steroid-free recipients
  3. An evaluation of the DGF nomogram in Thymoglobulin treated recipients at the University of Minnesota
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Kidney transplant recipients at the University of Minnesota

Criteria

Inclusion Criteria:

  • Kidney Transplant Recipient at the University of Minnesota
  • Kidney Transplant Recipients on steroid-free maintenance immunosuppression

Exclusion Criteria:

  • Non-kidney transplant patients at the University of Minnesota
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277770

Locations
United States, Minnesota
University Of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Arthur Matas, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01277770     History of Changes
Other Study ID Numbers: 00011652
Study First Received: August 19, 2010
Last Updated: August 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Thymoglobulin
Kidney Transplant Recipients
Steroid-Free
Immunosuppression

ClinicalTrials.gov processed this record on November 24, 2014