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A randomized control trial comparing the antibodies to COVID-19 vaccine between kidney transplant recipients who continue on immunosuppressive regimen of tacrolimus and mycophenolic acid and recipients who switch to mTOR inhibitor with low dose tacrolimus two weeks before vaccination

A randomized control trial comparing the antibodies to COVID-19 vaccine between kidney transplant recipients who continue on immunosuppressive regimen of tacrolimus and mycophenolic acid and recipients who switch to mTOR inhibitor with low dose tacrolimus two weeks before vaccination

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220404001
Enrollment
40
Registered
2022-04-04
Start date
2022-04-29
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplants recipients received 2 doses of ChAdOx1 nCoV-19 and 1 dose of BNT162b2 and receiving MPA and CNI Kidney transplants COVID SARS-CoV-2 Vaccine

Interventions

Switching immunosuppressive agents from MPA and CNI to low dose prograf (C0 2-4 ng/mL) and mTOR inhibitor 2 weeks before and after BNT162b2.,Remain using MPA and CNI throughout the study
Experimental Drug,Active Comparator Drug
Switching arm,Continue previous regimen

Sponsors

Division of nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 2. Kidney transplant > 6 months 3. Receiving MPA and CNI 4. Received 2 doses of ChAdOx1 nCoV-19 and 1 dose of BNT162b2 for 3-5 months

Exclusion criteria

Exclusion criteria: 1. History of severe allergy from BNT162b2 2. Rejection within 6 months 3. High risk for rejection : ABO incompatible, multiorgan transplantation, previous transplantation, recent panel reactive antibody (PRA) > 20% or donor specific antibody (DSA) positive 4. Pregnancy or lactation 5. Advanced stage cancer 6. AIDs

Design outcomes

Primary

MeasureTime frame
Anti-SARS-CoV-2 antibodies 1 month ELISA

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactAthiphat Banjongjit

Division of nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University

athiphat_b@hotmail.com0851094113

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026