Study Summary
This trial is investigating the use of Treg cells to prevent kidney rejection in patients undergoing a solitary kidney transplant. 12 participants will be enrolled at the University of Kentucky.
- Kidney Transplant
- Kidney Failure
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 2 Secondary · Reporting Duration: 6 to 12 weeks post transplant
Trial Safety
Safety Progress
Side Effects for
Trial Design
1 Treatment Group
Autologous Treg Infusion
1 of 1
Experimental Treatment
12 Total Participants · 1 Treatment Group
Primary Treatment: Apheresis · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 65 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Gedaly, Roberto, Felice De Stefano, Lilia Turcios, Marita Hill, Giovanna Hidalgo, Mihail I. Mitov, Michael C. Alstott, et al.. 2019. “Mtor Inhibitor Everolimus in Regulatory T Cell Expansion for Clinical Application in Transplantation”. Transplantation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/tp.0000000000002495.
- Roberto Gedaly 2019. "A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03284242.
Frequently Asked Questions
Is it possible for me to participate in this research endeavor?
"To qualify for this research initiative, prospective participants must have kidney failure, be of chronic nature and fall within the age range of 18-65. Approximately 12 recruits are needed to participate in this study." - Anonymous Online Contributor
Does this clinical trial include participants under the age of 40?
"This trial can accommodate participants aged 18 to 65. There are 23 independent studies for those younger and 246 trials specifically tailored to the elderly population." - Anonymous Online Contributor
How many participants are taking part in this experiment?
"Affirmative. The information available on clinicaltrials.gov attests that this medical trial, initially published on March 15th 2019, is actively recruiting patients. A single site is admitting 12 people for the study." - Anonymous Online Contributor
Are there any opportunities currently available to enroll in this research?
"Affirmative. The relevant data found on clinicaltrials.gov confirms that this medical study, which was first listed on March 15th 2019, is actively seeking subjects to enrol in the trial. A mere 12 patients are required from 1 site for participation and the last update occurred on May 16th 2022." - Anonymous Online Contributor