NCT03284242CompletedEarly phase 1
A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients
Tolerance Induction Using Autologous Regulatory T Cell Infusion and Zortress (Everolimus) in Renal Transplant Recipients: a Pilot Study
Source: ClinicalTrials.gov · Last updated 24 Jun 2024
Brief summary (registry, in English)
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 collecting, expanding and infusing a specific certain type of immune cell known as Regulatory T cells (Treg cells) to renal transplant recipients who are using Zortress (Everolimus) as immunosuppressive therapy. Treg cells, once they have been expanded in the laboratory to help prevent kidney rejection. Treg cells are collected from a participant's blood through a procedure called apheresis. Treg cells are a type of white blood cells that are able to suppress the activity of other immune cells responsible for organ rejection. The investigator plans to enroll 12 participants at the University of Kentucky.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 8 Aug 2017
- Start date
- 15 Mar 2019
- Primary completion date
- 10 Apr 2024
- Lead sponsor
- Roberto Gedaly
- Diseases
- Chronic kidney disease
- NCT number
- NCT03284242
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 9
- From 15 Mar 2019 to the primary completion date, 10 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous organ, tissue or cell transplant
- Previous chronic use of systemic glucocorticoids or other immunosuppression, or biologic immunomodulators
- Participation in other study that involved investigational drug or regimens in the preceding 12 months
- Chronic illness or prior treatment which, in the opinion of the investigator, precludes study participation
- Blood transfusion 3 months prior to transplant
Other illness
- Significant or active infection: HIV, Hepatitis B and C
- Active cancer or history of cancer within 3 years of screening
- History of delayed or abnormal wound healing
- History of non-compliance
Other
- Known sensitivity to Sirolimus, Everolimus, Tacrolimus or MMF
- Delayed graft function
- Pregnant or breastfeeding or refusal to us birth control
- Inability or unwillingness to comply with study protocol or procedures
- Chronic use of anticoagulants
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Medical Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.