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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug that may stabilize or improve kidney function for patients with chronic kidney disease (CKD) that has been caused by immunosuppressants. EVL is used for standard of care treatment to prevent transplant liver rejection in combination with other immunosuppressants, such as tacrolimus. The overall aim of this study is to examine a combination of two different immunosuppressants and EVL to determine if patients may have stabilized and/or improved kidney function without liver rejection. This study will look at how safe it is to slowly withdraw one anti-rejection medication while continuing to take the other medicine, and whether this can be done without liver rejection occurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus Withdrawal and Everolimus Monotherapy | Experimental | Tacrolimus will be tapered while continual use of everolimus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus Withdrawal and Everolimus Monotherapy | Drug | During the first month post-transplant, the subject receives everolimus (about 5-8 ng/mL) and tacrolimus with or without mycophenolic acid as part of standard of care procedures. At one month post-transplant, mycophenolic acid will be stopped and tacrolimus dosage will be reduced while continuing the dosage of everolimus. At three months post-transplant, tacrolimus dosage will be reduced by 50% of the daily dose each week. At four months post-transplant, tacrolimus will be discontinued. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection | flow cytometry immunophenotyping and gene expression microassays to assess amount of Treg cells and mRNA in peripheral blood in patients with and without rejection (after Tacc withdrwal) | Six months post transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josh Levitsky, MD, MS | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Comprehensive Transplant Center | Chicago | Illinois | 60611 | United States |
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28 patients consented but 8 were removed (n=1 withdrew, n=2 non compliant with protocol, n=2 new wound issues, n=1 high urine protein/creatinine ration and n=2 had neutropenia) Final sample for analysis is n=20
From May 2016 to May 2018, 170 adult primary LT were performed at our center. 20 Subjects underwent tac (Tacrolimus)withdrwal.
28 patients consented but 8 were removed
Final sample for analysis is n=20
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| ID | Title | Description |
|---|---|---|
| FG000 | Graft Rejection After Tacrolimus Was Discontinued (REJ) | Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6 |
| FG001 | No Graft Rejection After Tacrolimus Weaning (Non REJ) | NON-REJ patients did not required liver biopsy during the trial |
| FG002 | Removed From Study Before Tac Withdrawl Started | Removed from study before Tac withdrawl started |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Graft Rejection After Tacrolimus Was Discontinued (REJ) | Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6 |
| BG001 | No Graft Rejection After Tacrolimus Weaning (Non REJ) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection | flow cytometry immunophenotyping and gene expression microassays to assess amount of Treg cells and mRNA in peripheral blood in patients with and without rejection (after Tacc withdrwal) | 15 patients did not reject and 5 had mild rejection responding to tacrolimus resumption. | Posted | Mean | Standard Deviation | percentage of CD4 positive cell | Six months post transplantation |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Graft Rejection After Tacrolimus Was Discontinued (REJ) | Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josh Levitsky | Northwestern University | 312-695-4413 | j-levitsky@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2020 | Mar 2, 2022 | Prot_SAP_000.pdf |
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|
| Non Compliant |
|
NON-REJ patients did not required liver biopsy during the trial
| BG002 | Withdrew From Study Before Tacrolimus Weaning | These subjects were removed after consenting. These subjects were not initiated on TAC weaning |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Hepatocellular Carcinoma | Measure Analysis Population Description: Data was not collected for participant in the "Withdrew from study before Tacrolimus Weaning" Arm | no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Number | participants |
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| Primary Liver Disease- Hep C | Number | participants |
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| Primary Liver Disease- Alcohol | Number | participants |
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| Primary Liver Disease- Non Alcoholic Fatty Liver | Number | participants |
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| Primary Liver Disease- Other | Number | participants |
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| Tacrolimus Trough | Measure Description: Measure Analysis Population Description: Data was not collected for participant in the "Withdrew from study before Tacrolimus Weaning" Arm | Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Mean | Standard Deviation | ng/ml |
|
| Everolimus Trough | Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Mean | Standard Deviation | ng/ml |
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| Lab Value -White Blood Count | Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Mean | Standard Deviation | 1000 *cells*/mm^3 |
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| Lab Value -Hb | Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Mean | Standard Deviation | g/dl |
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| Lab Value -Platelet count | Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Mean | Standard Deviation | 1000 *cells*/mm^3 |
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| Lab Value -eGFR-MDRD | Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Mean | Standard Deviation | mL/min/1.73 m^2 |
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| Lab Value -Total Bilirubin | Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Mean | Standard Deviation | mg/dl |
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| Lab Value -AST | Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Mean | Standard Deviation | u/l |
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| Lab Value -ALT | Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Mean | Standard Deviation | u/l |
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| Lab Value -Alk Phos | Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning" | Mean | Standard Deviation | u/l |
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NON-REJ patients did not required liver biopsy during the trial |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | No Graft Rejection After Tacrolimus Weaning (Non REJ) | NON-REJ patients did not required liver biopsy during the trial | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Withdrew From Study Before Tacrolimus Weaning | Removed from study before Tac withdrawal started | 0 | 8 | 0 | 8 | 0 | 8 |
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| Male |
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