Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched
The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preced
| Condition(s) | End Stage Kidney Disease, Immunological Tolerance, Kidney Transplant Failure and Rejection, Chronic Kidney Diseases |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG). |
| Who can participate | Recipient Inclusion Criteria: 1. Males and females ages 18 years and older with a pre- existing kidney transplant from an HLA-matched living donor. 2. Pre-existing living kidney transplant must be within 3 months to 5 years from date of scheduled HPSC infusion. 3. No history of rejection with current HLA matched kidney transplant. 4. Recipient is without post-transplant major complications, including de novo malignancy, active infection or rejection. 5. Stable renal function determined per investigator discretion. 6. Agreement to participate in the study and ability to give informed consent. 7. Meets institutional criteria for HSPC infusion. 8. Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three to six months of the tr |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of California, Los Angeles |
| Locations | Los Angeles, California, United States |
| Start date | 2022-12-21 |
| NCT ID | NCT05525507 |
| Official listing | https://clinicaltrials.gov/study/NCT05525507 |