Status:
COMPLETED
A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients
Lead Sponsor:
Roberto Gedaly
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
End Stage Renal Disease
Kidney Transplant
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
This study will enroll individuals who have end stage renal disease and who are undergoing a solitary kidney transplant. This study is investigating/evaluating the safety and effectiveness of collecti...
Detailed Description
The purpose of this research study is to learn alternative ways to control the body's immune responses after renal transplantation. The investigator's goal is to prevent or reduce the side-effects of ...
Eligibility Criteria
Inclusion
- Fluent in English able to understand and provide informed consent
- End stage renal disease listed for primary solitary kidney transplant
- Willing to participate in the study and comply with study requirements
- Female participants must agree to use 2 different birth control methods
Exclusion
- History of previous organ, tissue or cell transplant
- Known sensitivity to Sirolimus, Everolimus, Tacrolimus or MMF
- Previous chronic use of systemic glucocorticoids or other immunosuppression, or biologic immunomodulators
- Significant or active infection: HIV, Hepatitis B and C
- Active cancer or history of cancer within 3 years of screening
- Participation in other study that involved investigational drug or regimens in the preceding 12 months
- History of delayed or abnormal wound healing
- Delayed graft function
- Chronic illness or prior treatment which, in the opinion of the investigator, precludes study participation
- Pregnant or breastfeeding or refusal to us birth control
- Inability or unwillingness to comply with study protocol or procedures
- Chronic use of anticoagulants
- Blood transfusion 3 months prior to transplant
- History of non-compliance
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03284242
Start Date
March 15 2019
End Date
April 10 2024
Last Update
June 24 2024
Active Locations (1)
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1
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536