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Antacid administration and tacrolimus exposure

Effects of antacid administration time on tacrolimus trough concentration to dose ratio in kidney transplant recipients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20260223010
Enrollment
150
Registered
2026-02-23
Start date
2026-02-17
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 transplant recipients kidney transplant

Interventions

kidney transplant recipients receiving concomitant (within 2 hours) antacid with tacrolimus dose,kidney transplant recipients receiving an antacid administered 2 hours or more apart from tacrolimus do
antacid concomitant group,separate timing group,no antacid group

Sponsors

Department of Pharmacy Practice, Chulalongkorn University
Lead Sponsor
Doctor Kasem Foundation
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged 18 years or more and provided informed consent to participate in the study. 2) KTRs who were admitted to the inpatient ward at Rajavithi Hospital. 3) KTRs receiving twice-daily oral tacrolimus as the primary immunosuppressive regimen 4) Patients with available tacrolimus trough concentration measurements at steady state

Exclusion criteria

Exclusion criteria: 1) Multiorgan transplant recipients 2) Patients diagnosed with active liver disease, including viral hepatitis, hepatocellular carcinoma, or liver cirrhosis, or with liver enzyme levels higher than 3 times the upper limit of normal values 3) Patients receiving clinically significant drug interactions affecting tacrolimus pharmacokinetics, except for the study antacids, prednisolone, proton pump inhibitors, and diltiazem 4) Patients receiving combination antacid or gastric mucosal protective suspensions containing aluminum hydroxide, magnesium hydroxide, and simethicone, or antacid/laxative liquid formulations containing magnesium hydroxide 5) Patients with incomplete medical records 6) Patients who died prior to study initiation

Design outcomes

Primary

MeasureTime frame
tacrolimus trough concentration to dose ratio morning trough whole blood concentration to dose ratio

Secondary

MeasureTime frame
tacrolimus trough concentration morning trough CMIA

Countries

Thailand

Contacts

Public Contactsaowarat phacheroen

Rajavithi Hospital

pharmdnavi@gmail.com0833699665

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026