| Trial ID: | L1223 |
| Source ID: | NCT03284242
|
| Associated Drug: |
Treg
|
| Title: |
A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease|Kidney Transplant
|
| Interventions: |
DRUG: Treg
|
| Outcome Measures: |
Primary: Changes in Tregs Infusion Toxicities, Laboratory measurement and observed toxicities immediately and with in 24 hours post infusion of Tregs., Immediately following Tregs infusion and again within 24 hours after Tregs infusion|Changes in Kidney Function, Creatinine level measurement, for 2 years from the start of the study|Changes In Steroid Resistance Rejection Rates, Laboratory measurement, 1, 6 and 12 months post Tregs infusion|Infectious Complications, Laboratory measurement, for 2 years from the start of the study | Secondary: Treg cell measurements within the allograft, Renal biopsy, 6 to 12 weeks post transplant|Circulating T cell subset measurements, laboratory analysis, twice a week for 4 weeks then weekly for 3 months
|
| Sponsor/Collaborators: |
Sponsor: Roberto Gedaly | Collaborators: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
9
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-03-15
|
| Completion Date: |
2024-04-10
|
| Results First Posted: |
|
| Last Update Posted: |
2024-06-24
|
| Locations: |
University of Kentucky Medical Center, Lexington, Kentucky, 40536, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03284242
|
