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| Name | Class |
|---|---|
| Transplant Genomics, Inc. | INDUSTRY |
| CareDx | INDUSTRY |
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This study will examine whether renal transplant recipients treated with a belatacept-based immunosuppressive regimen can safely be weaned off all non-belatacept immunosuppression (mycophenolate, mTORi, prednisone) in a stepwise fashion. To this end, participants will undergo monthly "immune monitoring" using the Allosure (dd-cfDNA) and Trugraf (RNA profiling) blood tests to determine if they are in a state of immune quiescence. Only patients who are deemed to be immune quiescent, will continue to be weaned of non-belatacept immunosuppression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belatacept treated patients | Experimental | Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allosure | Diagnostic Test | Monthly monitoring of dd-cfDNA levels in blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute Rejection | Biopsy-proven according to Banff 2017 criteria | Enrollment through 12 months |
| Incidence of Acute Rejection | Biopsy-proven according to Banff 2017 criteria | Through study completion, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in eGFR | Calculated using CKD-EPI formula | From baseline to 12 months |
| Rate of New-onset Proteinuria | Defined as g/g creatinine, measured on random urine sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannah Gilligan, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
There is no plan to share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Belatacept Treated Patients | Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood Immunosuppression reduction: Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results Trugraf: Monthly monitoring of Trugraf result |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Belatacept Treated Patients | Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood Immunosuppression reduction: Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results Trugraf: Monthly monitoring of Trugraf result |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Incidence of Acute Rejection | Biopsy-proven according to Banff 2017 criteria | Posted | Count of Participants | Participants | Enrollment through 12 months |
|
|
2 Years
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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 | Belatacept Treated Patients | Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood Immunosuppression reduction: Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results Trugraf: Monthly monitoring of Trugraf result |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hannah Gilligan, MD | Massachusetts General Hospital | 617-726-2000 | hgilligan@mgh.harvard.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 25, 2019 | Oct 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| D009173 | Mycophenolic Acid |
| D020123 | Sirolimus |
| D000068338 | Everolimus |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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Prospective single-center, single-arm pilot study
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| Immunosuppression reduction | Drug | Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results |
|
|
| Trugraf | Diagnostic Test | Monthly monitoring of Trugraf result |
|
| At 12 months |
| Incidence of de Novo Donor Specific Antibodies | Screened for using Luminex platform | At 12 months |
| Survival | Overall and death-censored graft survival | At 12 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Increase in eGFR | Calculated using CKD-EPI formula | Posted | Count of Participants | Participants | From baseline to 12 months |
|
|
|
| Secondary | Rate of New-onset Proteinuria | Defined as g/g creatinine, measured on random urine sample | Posted | Count of Participants | Participants | At 12 months |
|
|
|
| Secondary | Incidence of de Novo Donor Specific Antibodies | Screened for using Luminex platform | Posted | Count of Participants | Participants | At 12 months |
|
|
|
| Secondary | Survival | Overall and death-censored graft survival | Posted | Count of Participants | Participants | At 12 months |
|
|
|
| Primary | Incidence of Acute Rejection | Biopsy-proven according to Banff 2017 criteria | Posted | Count of Participants | Participants | Through study completion, 1 year |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| Elevated LFTs | Investigations | Systematic Assessment |
|
| Fatigue | Investigations | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Elevated Creatinine | Investigations | Systematic Assessment |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |