EUCTR2022-000617-13-ES
Active, not recruiting
Phase 1
A prospective, randomized, controlled trial assessing the effect of conversion from Tacrolimus-antimetabolite to Tacrolimus-mTor-inhibitors based immunosuppression to booster SARS-CoV-2-specific seroconversion after a fourth dose of SARS-CoV-2 mRNA vaccine in unresponsive Solid Organ Transplant recipients - TOR-VAX
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)0 sites50 target enrollmentMarch 4, 2022
ConditionsSeroconversion is evaluated after changing treatment from tacrolimus to tacrolimus + mTOR inhibitor in solid organ transplant patients who have not responded to the first three doses of the vaccineMedDRA version: 21.0Level: PTClassification code 10080575Term: Solid organ transplantSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Immune system processes [G12]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Seroconversion is evaluated after changing treatment from tacrolimus to tacrolimus + mTOR inhibitor in solid organ transplant patients who have not responded to the first three doses of the vaccine
- Sponsor
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patient’s age \= 18 years
- •2\.Time of transplantation \= 1 year
- •3\.Negative or very weak (\<143BAU/ml) serological immune response after 3 doses of an mRNA SARS\-CoV\-2 vaccine
- •4\.Stable renal function with an estimated GFR \= 40 mL/min/1\.73 m2
- •5\.Urine protein to creatinine ratio \< 0\.8 g/g
- •6\.Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 35
Exclusion Criteria
- •1\.Previous diagnosis of T\-cell mediated or antibody\-mediated rejection
- •2\.Previous seroconversion after any SARS\-CoV\-2 vaccine.
- •3\.Previous COVID\-19 infection
- •4\.Presence of HLA donor\-specific antibodies
- •5\.Active cancer excluding non\-melanoma skin cancer
- •6\.Pregnancy
Outcomes
Primary Outcomes
Not specified
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