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The main purpose of this study is to find out whether treatment to prevent kidney rejection with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result in less delayed graft function or "sleepy kidney" after transplant than that seen in patients who get tacrolimus as their main drug to prevent rejection instead of belatacept. The investigators will also look at whether patients who get belatacept have the same, lesser or more problems that those who get tacrolimus.
New York Presbyterian Hospital-Columbia University Medical Center (NYPH-CUMC) performs nearly 250 renal transplants annually; of these approximately half are recipients of a variety of deceased donor kidneys, usually with cold ischemia time (CIT) >24 hours leading to an approximate incidence of delayed graft function (DGF) of 50%. The main focus of this study will be to determine whether initial immunosuppression with belatacept with Thymoglobulin induction will result in lower incidence and/or more rapid disappearance of DGF than that observed in patients who receive tacrolimus based immunosuppression. NGAL determinations will bne made in the first months after transplantation to correlate with clinical DGF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belatacept Immunosuppression | Experimental | Renal transplant recipients will receive steroids (Methylprednisolone), rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation. |
|
| Standard Immunosuppression (Tacrolimus) | Active Comparator | Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belatacept | Drug | Belatacept 10 mg/kg will be administered in the operating room approximately 1 hour prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: Day 5, 14, 30, 56, and 84. Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Delayed Graft Function (DGF) | To assess whether treatment with Thymoglobulin induction and belatacept based maintenance immunosuppression would reduce delayed graft function (DGF) rates among recipients of deceased donor renal transplants as measured by clinical findings and NGAL marker, as specified below and defined by others. This will be compared to the incidence of DGF in patients treated with a Tacrolimus based regimen. Patients who require hemodialysis in the first 7 days after transplantation and/or patients whose serum creatinine decreases <10% during 3 consecutive days after the transplant will be considered to have DGF in the absence of other confounding factors such as obstruction or infection. NGAL will be used as a verification marker of DGF. | Up to 3 months post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Allograft Survival | Allograft survival is defined as functioning renal transplant. | Up to 1 year post-transplantation |
| Number of Participants With an Allograft Rejection Episode |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A. Hardy, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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Patients called into the hospital for potential renal transplants were approached for possible participation in the study if they agreed to discuss research and were eligible per study criteria. Patients were given the option to participate or decline.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belatacept Immunosuppression | Renal transplant recipients will receive Methylprednisolone, rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation. Belatacept 10 mg/kg will be administered in the operating room ~1 hr prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: 5, 14, 30, 56, & 84. Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study. Standard of Care:
|
| FG001 | Standard Immunosuppression (Tacrolimus) | Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation. Tacrolimus 0.05 mg/kg PO every 12 hrs will be on Day 0 after transplantation. It will then be administered on the following post-transplantation days: 3-90 at 8-12ng/mL; Day 91-180 at 8-10 ng/mL. Standard of Care:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Belatacept Immunosuppression | Renal transplant recipients will receive Methylprednisolone, rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation. Belatacept 10 mg/kg will be administered in the operating room ~1 hr prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: 5, 14, 30, 56, & 84. Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study. Standard of Care:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Number of Participants With Delayed Graft Function (DGF) | To assess whether treatment with Thymoglobulin induction and belatacept based maintenance immunosuppression would reduce delayed graft function (DGF) rates among recipients of deceased donor renal transplants as measured by clinical findings and NGAL marker, as specified below and defined by others. This will be compared to the incidence of DGF in patients treated with a Tacrolimus based regimen. Patients who require hemodialysis in the first 7 days after transplantation and/or patients whose serum creatinine decreases <10% during 3 consecutive days after the transplant will be considered to have DGF in the absence of other confounding factors such as obstruction or infection. NGAL will be used as a verification marker of DGF. | Posted | Count of Participants | Participants | Up to 3 months post-transplantation |
|
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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 Immunosuppression | Renal transplant recipients will receive Methylprednisolone, rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation. Belatacept 10 mg/kg will be administered in the operating room ~1 hr prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: 5, 14, 30, 56, & 84. Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study. Standard of Care:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Graft Function | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark A. Hardy | Columbia University Irving Medical Center | (212) 305-5502 | mah1@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D020360 | Neoadjuvant Therapy |
| D000961 | Antilymphocyte Serum |
| D008775 | Methylprednisolone |
| D016030 | Kidney Transplantation |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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|
|
| Tacrolimus | Drug | Tacrolimus 0.05 mg/kg by mouth every 12 hours will be on Day 0 after transplantation. It will then be administered at 8-12 ng/mL on the following post-transplantation days: Day 3-90; at 8-10 ng/mL Day 91-180. Tacrolimus 6 - 8 ng/mL will be administered daily thereafter until end of study. (standard of care) |
|
|
| Mycophenolate | Drug | An immunosuppressive agent used with other medicines to lower the body's natural immunity in patients who receive kidney transplants. 720 mg by mouth every 12 hours (Day 0)(1080 mg AA). (standard of care) |
|
|
| rATG | Drug | 1.5 mg/kg IV daily on Day 0-3. (standard of care) |
|
|
| Methylprednisolone | Drug | 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3. (standard of care) |
|
|
| Renal transplant | Procedure | Standard organ transplant of a kidney into a patient with end-stage renal disease. |
|
|
All rejection episodes will be confirmed by renal transplant biopsy provoked by change in renal function not explained by other clinical causes.
| Up to 1 year post-transplantation |
| Estimated Glomerular Filtration Rate (eGFR) | Estimated glomerular filtration rate (eGFR) is based on a blood sample (serum creatinine value), age, race, and gender. eGFR estimates best the function of the kidney at any one time. | Up to 1 year post-transplantation |
| BG001 | Standard Immunosuppression (Tacrolimus) | Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation. Tacrolimus 0.05 mg/kg PO every 12 hrs will be on Day 0 after transplantation. It will then be administered on the following post-transplantation days: 3-90 at 8-12ng/mL; Day 91-180 at 8-10 ng/mL. Standard of Care:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Standard Immunosuppression (Tacrolimus) | Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation. Tacrolimus 0.05 mg/kg PO every 12 hrs will be on Day 0 after transplantation. It will then be administered on the following post-transplantation days: 3-90 at 8-12ng/mL; Day 91-180 at 8-10 ng/mL. Standard of Care:
|
|
|
| Secondary | Percentage of Participants With Allograft Survival | Allograft survival is defined as functioning renal transplant. | Posted | Count of Participants | Participants | Up to 1 year post-transplantation |
|
|
|
| Secondary | Number of Participants With an Allograft Rejection Episode | All rejection episodes will be confirmed by renal transplant biopsy provoked by change in renal function not explained by other clinical causes. | Posted | Count of Participants | Participants | Up to 1 year post-transplantation |
|
|
|
| Secondary | Estimated Glomerular Filtration Rate (eGFR) | Estimated glomerular filtration rate (eGFR) is based on a blood sample (serum creatinine value), age, race, and gender. eGFR estimates best the function of the kidney at any one time. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Up to 1 year post-transplantation |
|
|
|
| 4 |
| 24 |
| 14 |
| 24 |
| 5 |
| 24 |
| EG001 | Standard Immunosuppression (Tacrolimus) | Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation. Tacrolimus 0.05 mg/kg PO every 12 hrs will be on Day 0 after transplantation. It will then be administered on the following post-transplantation days: 3-90 at 8-12ng/mL; Day 91-180 at 8-10 ng/mL. Standard of Care:
| 1 | 24 | 15 | 24 | 3 | 24 |
| Rejection | Renal and urinary disorders | Systematic Assessment |
|
| EBV quant+ | Infections and infestations | Systematic Assessment |
|
| CMV quant+ | Infections and infestations | Systematic Assessment |
|
| BK quant+ | Infections and infestations | Systematic Assessment |
|
| Posttransplant lymphoproliferative disease | Renal and urinary disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D007106 | Immune Sera |
| D007162 | Immunoproteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D017582 | Renal Replacement Therapy |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |