None listed
Conditions
Interventions
Drug : Investigational Drug: K-CAB Tablet 50 mg (HK Inno.N Corp., Tegoprazan)
In this clinical trial, a dosage of 50 mg will be administered once daily. Symptom maintenance or resolution will be asses
Sponsors
Kyungpook National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 19 years or older. 2. Patients who have received a kidney transplant only. 3. Patients taking tacrolimus, mycophenolic acid, and steroids as immunosuppressants after kidney transplantation. 4. Patients who have experienced heartburn symptoms for at least one month prior to the date of written consent. 5. Patients with the ability and willingness to provide informed consent, who have personally signed the informed consent form following appropriate procedures, and are able to comply with study visits and participation according to the study protocol. 6. Patients requiring immunosuppressive therapy for at least 12 weeks after inclusion in the study.
Exclusion criteria
Exclusion criteria: 1. Patients who refuse monitoring. 2. Patients with a history of treatment for acute rejection within the past 3 months. 3. Patients with active infectious diseases. 4. Patients with visual or hearing impairments, inability to manipulate limbs, or skin hypersensitivity that may interfere with the use of smart pillboxes and biometric devices. 5. Patients taking antipsychotics, antidepressants, or anxiolytics. 6. Patients currently on atazanavir, nelfinavir, or rilpivirine-containing medications. 7. Patients with hypersensitivity or a history of hypersensitivity to potassium-competitive acid blockers or benzimidazole derivatives. 8. Patients showing clinically significant abnormal values in screening tests (AST [GOT], ALT [GPT] > 2 times the upper limit of the institution's normal range). 9. Patients deemed unsuitable for clinical trial participation for other reasons by the investigator. 10. Patients of childbearing potential who do not agree to use adequate contraception during the clinical trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the drug concentrations of immunosuppressants (tacrolimus, mycophenolic acid) after the administration of tegoprazan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunologic outcomes (biopsy-proven acute rejection, changes in kidney function, graft loss);patient satisfaction with the smart clinical trial management platform.;Reflux Disease Questionnaire (RDQ): Assessment of gastroesophageal reflux disease symptoms and Health-Related Quality of Life (HRQL) evaluation;Safety assessment variables (vital signs, clinical laboratory tests, adverse events) | — |
Countries
Korea, Republic of
Contacts
Public ContactYou Hyun Jeon
Kyungpook National University Hospital
Outcome results
None listed