Trials / Unknown
UnknownNCT03465397
Individualization of the Immunological Risk Based on Selective Biomarkers in Living-donor Renal Recipients
Multicenter, Randomized Study to Evaluate the Effectiveness of the Individualization of the Immunological Risk Based on Biomarkers (Disparity of HLA and IFN-γ ELISPOT) to Optimize Immunosuppressor Treatment in Living-donor Renal Recipients
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 164 (estimated)
- Sponsor
- ORIOL BESTARD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a clinical trial comparing the immunosuppressive treatment determined according to two biomarkers, donor-specific IFN-γ ELISPOT and Mismatch of HLA between donor and recipient, in patients undergoing low immunological risk live donor kidney transplantation
Detailed description
This is a national multicenter clinical trial, controlled, randomized, stratified, parallel groups, and without masking. This is a prospective intervention study in which two strategies for determining immunosuppressive treatment in kidney transplant patients from a live donor with low immunological risk are compared according to solid phase antibody detection techniques (cPRA 0% and isolated negative antigen) and crossmatch by negative cytotoxicity. Patients are randomized in a 1: 1 ratio to receive one of two immunosuppressive treatment strategies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | biomarkers driven immunosuppressive therapy | the immunosuppressive treatment of the patients is determined according to the result of 2 biomarkers of immunological risk |
Timeline
- Start date
- 2017-11-10
- Primary completion
- 2021-11-01
- Completion
- 2021-11-01
- First posted
- 2018-03-14
- Last updated
- 2021-01-08
Locations
6 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT03465397. Inclusion in this directory is not an endorsement.