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| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
| University of Washington | OTHER |
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To create a formula that adjusts tacrolimus blood levels. This is needed because pregnant patients have higher levels of unbound tacrolimus. The adjusted formula will give a more accurate measure of the active drug in pregnant uterus transplant patients.
A non-linear mixed effects model describing tacrolimus exposure in pregnant and non-pregnant subjects will be developed using prospectively collected de-identified data from pregnant uterus transplant recipients at BUMC.
The model will be analyzed to develop an estimating equation for tacrolimus unbound concentrations from whole blood concentrations, albumin and hematocrit during each trimester of pregnancy.
The estimating equation will then be applied to data from uterus transplant recipients enrolled in this study and retrospectively to uterus recipients transplanted since October 2020 to clinically validate the findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Individuals | Individuals who had a uterus transplant that are using tacrolimus during pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modeling of unbound and whole blood tacrolimus in pregnant uterus transplant recipients | Biological | Develop an estimating equation to correct tacrolimus whole blood concentrations given the known increase in the unbound tacrolimus concentration in pregnant patients to obtain a more accurate picture of active tacrolimus exposure (unbound drug) in pregnant uterus transplant recipients. |
| Measure | Description | Time Frame |
|---|---|---|
| Understanding Tacrolimus Levels in Pregnancy | Develop a joint non-linear mixed effect population pharmacokinetic model describing bound and unbound tacrolimus pharmacokinetics in pregnant subjects. | 2nd (weeks 13-26) and 3rd (weeks 27-40) trimester of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusting Tacrolimus Blood Levels by Trimester | Create an equation to adjust whole blood tacrolimus concentrations for changes in drug binding during each trimester at the point of care | 2nd (weeks 13-26) and 3rd (weeks 27-40) trimester of pregnancy |
| Linking the Mixed Pharmacokinetic Model and the Equation to Adjust Whold Blood Tacrolimus Concentrations to Active Tacrolimus Levels During and After Pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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biologically born women
Uterus transplant recipient over 18 years of age receiving tacrolimus for immunosuppression.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley McAllister | Contact | 214-820-1710 | ashley.mcallister@bswhealth.org | |
| Taryn Kruse | Contact | 214-820-1767 | taryn.kruse@bswhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Wilson, Pharmacist | Baylor Scott and White Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Center of Dallas | Dallas | Texas | 75246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2023 Annual Data Report. U.S. Department of Health and Human Services, Health Resources and Services Administration; 2025. | ||
| 39207751 | Background | Yo JH, Fields N, Li W, Anderson A, Marshall SA, Kerr PG, Palmer KR. Adverse Pregnancy Outcomes in Solid Organ Transplant Recipients: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Aug 1;7(8):e2430913. doi: 10.1001/jamanetworkopen.2024.30913. | |
| 27295076 |
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Blood
|
Correlate clinical outcomes with estimated unbound tacrolimus concentrations from uterus transplant recipients during each trimester and outside of pregnancy using whole blood trough concentrations and the model developed in Outcome 1 |
| 1 week postpartum, 4 weeks, 5 weeks and 6 weeks postpartum |
| Background |
| Rodrigues-Diez R, Gonzalez-Guerrero C, Ocana-Salceda C, Rodrigues-Diez RR, Egido J, Ortiz A, Ruiz-Ortega M, Ramos AM. Calcineurin inhibitors cyclosporine A and tacrolimus induce vascular inflammation and endothelial activation through TLR4 signaling. Sci Rep. 2016 Jun 13;6:27915. doi: 10.1038/srep27915. |
| 19218475 | Background | Naesens M, Kuypers DR, Sarwal M. Calcineurin inhibitor nephrotoxicity. Clin J Am Soc Nephrol. 2009 Feb;4(2):481-508. doi: 10.2215/CJN.04800908. |
| 23007747 | Background | Zheng S, Easterling TR, Umans JG, Miodovnik M, Calamia JC, Thummel KE, Shen DD, Davis CL, Hebert MF. Pharmacokinetics of tacrolimus during pregnancy. Ther Drug Monit. 2012 Dec;34(6):660-70. doi: 10.1097/FTD.0b013e3182708edf. |
| 37596793 | Background | Schagen MR, Ulu AN, Francke MI, van de Wetering J, van Buren MC, Schoenmakers S, Matic M, van Schaik RHN, Hesselink DA, de Winter BCM. Modelling changes in the pharmacokinetics of tacrolimus during pregnancy after kidney transplantation: A retrospective cohort study. Br J Clin Pharmacol. 2024 Jan;90(1):176-188. doi: 10.1111/bcp.15886. Epub 2023 Sep 4. |
| 38084781 | Background | Versluis J, Bourgonje AR, Touw DJ, Meinderts JR, Prins JR, de Jong MFC, Mian P. Pharmacokinetics of Tacrolimus in Pregnant Solid-Organ Transplant Recipients: A Retrospective Study. J Clin Pharmacol. 2024 Apr;64(4):428-436. doi: 10.1002/jcph.2393. Epub 2024 Jan 4. |
| 39968606 | Background | Brannstrom M. A decade of human uterus transplantation. Acta Obstet Gynecol Scand. 2025 Mar;104(3):434-436. doi: 10.1111/aogs.15080. Epub 2025 Feb 19. No abstract available. |
| 29575738 | Background | Testa G, McKenna GJ, Gunby RT Jr, Anthony T, Koon EC, Warren AM, Putman JM, Zhang L, dePrisco G, Mitchell JM, Wallis K, Klintmalm GB, Olausson M, Johannesson L. First live birth after uterus transplantation in the United States. Am J Transplant. 2018 May;18(5):1270-1274. doi: 10.1111/ajt.14737. Epub 2018 Apr 12. |
| 36445981 | Background | Wilson NK, Schulz P, Wall A, Parrott M, Testa G, Johannesson L, Sam T. Immunosuppression in Uterus Transplantation: Experience From the Dallas Uterus Transplant Study. Transplantation. 2023 Mar 1;107(3):729-736. doi: 10.1097/TP.0000000000004437. Epub 2023 Feb 21. |