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Omeprazole and Famotidine in Chronic Dysfunction of the Transplanted Kidney

NCT05061303 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2023-01-23

No results posted yet for this study

Summary

The aim of the study is to compare the effect of omeprazole and famotidine on the risk of developing chronic renal transplant dysfunction. For the study, it is planned to qualify 24 stabilized adult patients from 1-24 months after kidney transplantation, who will receive p.o. the standard, most commonly used triple immunosuppression regimen: tacrolimus, mycophenolate mofetil, prednisone and depending on the group p.o.: omeprazole 20 mg (group I) or famotidine 20 mg (group II). The material in the study will be blood, in which tacrolimus concentrations will be measured at the following time points: 0, 2h, 6h, 12h after drug administration, without taking omeprazole/famotidine and then the next day after taking the protective drug in same time points, without 12h. Sequentially routinely in the so-called point T0 before taking the drug (12 hours after the last dose) during follow-up visits at the Transplant Outpatient Clinic. Tacrolimus concentrations will be determined using the Chemiluminescent Microparticle Immuno Assay method. As standard, laboratory tests will be performed during follow-up visits.

In addition, it is planned to assess titer of donor-specific antibodies at the time of qualification and then after 18 months, immunological profile (flow cytometry) at the time of qualification and then after 18 months, and concentration in serum and urine of a potential marker of progression and decrease in glomerular filtration - kidney injury molecule-1 at the time of qualification and then after 18 months. The obtained results will be correlated with the histopathological evaluation of the transplanted kidney in the case of organ biopsy performed on clinical indications.

Comparative statistical analysis of drug concentration values will be carried out. Additionally, genetic tests will be performed to assess the patient's metabolic variant for CYP2C19. Due to the potential influence of omeprazole on the pharmacokinetics of tacrolimus, which may influence the process of chronic rejection of the transplanted kidney and drug toxicity, it seems important to study this hypothesis, as well as researching for therapeutic substances neutral to the above process. The use of famotidine in place of omeprazole may turn out more beneficial and safer for renal transplant patients. During follow-up visits at the Transplant Clinic at the Department and Clinic of Nephrology, Transplantology and Internal Diseases, changes in blood concentrations of tacrolimus are noticed. Related reasons are being looked for. The above study will confirm or reject the relationship of changes in tacrolimus levels with omeprazole. It is planned to present the results at a scientific conference. The research results will be published in a scientific journal.

Conditions

  • Kidney Rejection Transplant

Interventions

OTHER

Assessment of the drug concentration in the blood

The material in the study will be blood, in which tacrolimus concentrations will be measured at the following time points: 0, 2hours, 6hours, 12hours after drug administration, without taking omeprazole/famotidine and then the next day after taking the protective drug in same time points, without 12hours. Sequentially routinely in the so-called point T0 before taking the drug (12 hours after the last dose) during follow-up visits at the Transplant Outpatient Clinic.

Sponsors & Collaborators

  • Poznan University of Medical Sciences

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-17
Primary Completion
2023-01-19
Completion
2024-06-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05061303 on ClinicalTrials.gov