prospective, randomized, controlled study evaluating the effect of conversion from tacrolimus treatment to mTor inhibitor-based immunosuppression + tacrolimus to boost conversion to positive SARS-CoV-2 serology after a fourth dose of the vaccine of SARS-CoV-2 mRNA in solid organ transplant recipients who have not previously responded.

Phase 1

• 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; MedDRA version: 21.0Level: PTClassification code 10080575Term: Solid organ transplantSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2022-000617-13-ES
• Lead Sponsor: Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-04
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified