| Primary | Percent of Participants Who Achieved Operational Tolerance | Operational tolerance is defined as remaining off all immunosuppression 52 weeks after completion of immunosuppression withdrawal, with no evidence of biopsy-proven allograft rejection and, with acceptable renal function defined as a serum creatinine that has increased no more than 25% above baseline at the primary endpoint visit. Baseline creatinine is defined as the average of the lowest three creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval. | Transplanted Per Protocol Participants | Posted | | Number | 95% Confidence Interval | Percent of participants | | Transplantation through 52 Weeks after Discontinuation of All Immunosuppression | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant | Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. | Transplanted Per Protocol Participants | Posted | | Count of Participants | | Participants | | Transplant to Two Years Post-Transplant | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Severity of Graft-versus-Host Disease in Transplanted Participants | Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Severity of GVHD is based on skin, liver, and intestinal tract symptoms, ranging from I to IV, with IV being the worst. This measure counts the number of participants experiencing GVHD by severity. | Transplanted Per Protocol Participants | Posted | | Count of Participants | | Participants | | Transplant to Two Years Post-Transplant | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Duration in Days of Graft-versus-Host Disease in Transplanted Participants | Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Duration (in days) is measured as the time from the start of the GVHD event to the end of the GVHD event. | Transplanted Per Protocol Participants | Posted | | Mean | Standard Deviation | Days | | Transplant to Two Years Post-Transplant | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | .Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Transplanted Participants With Engraftment Syndrome | Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil counts ≥ 500 per µL), without apparent other cause. | Transplanted Per Protocol Participants | Posted | | Count of Participants | | Participants | | Transplant to End of Study (Up to 25 months After Enrollment) | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Duration in Days of Engraftment Syndrome in Transplanted Participants | Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil count ≥ 500 per µL), without apparent other cause. Duration (in days) is measured as the time from the start of the engraftment syndrome event to the end of the engraftment syndrome event. | No statistical analyses provided for 'Duration of Engraftment Syndrome in Transplanted Participants' because no participants in the Per Protocol population experienced engraftment syndrome. | Posted | | | | | | Transplant to End of Study (Up to 25 months After Enrollment) | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Transplanted Participants Who Died | Number of participant deaths after receiving a transplant per protocol. | Transplanted Per Protocol Participants | Posted | | Count of Participants | | Participants | | Transplant to End of Study (Up to 25 months After Enrollment) | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Transplanted Participants With Acute Renal Allograft Rejection | Acute renal allograft rejection demonstrated either by biopsy or clinically (when a biopsy could not be performed). This measure includes participants with biopsy proven acute renal allograft rejection and those that have creatinine values 25% or greater relative to baseline for over 72 hours. Baseline serum creatinine is defined as the average of the lowest three serum creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. | Transplanted Per Protocol Participants | Posted | | Count of Participants | | Participants | | Transplant to End of Study (Up to 25 months After Enrollment) | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology | This outcome includes results from biopsies with proven acute renal allograft rejection according to the 2007 Banff Classification Renal Allograft Pathology. A Banff result of indeterminate is not classified as rejection. | Transplanted Per Protocol Participants | Posted | | Number | | participants | | Transplant to End of Study (Up to 25 months After Enrollment) | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection | Outcome includes participants who experienced chronic T cell-mediated rejection, antibody-mediated rejection and progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy, without an alternative, non-rejection related cause. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms. | Transplanted Per Protocol Participants | Posted | | Count of Participants | | Participants | | Transplant to End of Study (Up to 25 months After Enrollment) | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment | Number of days post-transplant to the first episode of acute rejection that required treatment. This includes acute rejection episodes requiring treatment that were not biopsy proven. | Transplanted Per Protocol Participants who experienced acute rejection. | Posted | | Mean | Standard Deviation | Days | | Transplant to End of Study (Up to 25 months After Enrollment) | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy | AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. | Safety population, which includes all participants who received any study medication. | Posted | | Number | | Events | | First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment) | | | | ID | Title | Description |
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| OG000 | Enrolled, Not Transplanted | Participants were consented and enrolled in the study, but did not receive a full evaluation of all criteria for study participation. These participants were terminated during the screening process due to a decision by study sponsor. | | OG001 | Enrolled, Transplanted | Participants were consented, enrolled, fulfilling all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy | AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0. | Safety population, which includes all participants who received any study medication. | Posted | | Number | | Events | | First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment) | | | | ID | Title | Description |
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| OG000 | Enrolled, Not Transplanted | Participants were consented and enrolled in the study, but did not receive a full evaluation of all criteria for study participation. These participants were terminated during the screening process due to a decision by study sponsor. | | OG001 | Enrolled, Transplanted | Participants were consented, enrolled, fulfilling all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy | AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Time (in days) from the start date of the AE until the end date of the AE. Two events contributed to this calculation. | Participants who received any study medication and experienced at least one AE inclusive of infection, wound complications, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. | Posted | | Mean | Standard Deviation | Days | | First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment) | | | | ID | Title | Description |
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| OG000 | Enrolled, Not Transplanted | Participants were consented and enrolled in the study, but did not receive a full evaluation of all criteria for study participation. These participants were terminated during the screening process due to a decision by study sponsor. | | OG001 | Enrolled, Transplanted | Participants were consented, enrolled, fulfilling all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal | Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. | Transplanted Per Protocol Participants | Posted | | Count of Participants | | Participants | | Initiation of Immunosuppression Withdrawal to End of Study (to 25 months) | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation | Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. | Transplanted Per Protocol Participants | Posted | | Count of Participants | | Participants | | Transplant to End of Study (Up to 25 months) | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery | Time (in days) from neutrophil nadir, the first day post-transplant on which the absolute neutrophil count (ANC) is below 500 per µL, to the first day after three consecutive daily ANCs ≥ 500 per µL. ANC is a measure of the number of neutrophils present in the blood. Neutrophils are a type of white blood cell that fight against infection. A healthy person has an ANC between 2,500 and 6,000 per µL. A value below 500 per µL means the risk of infection is higher. | Transplanted Per Protocol Participants | Posted | | Mean | Standard Deviation | Days | | Post-Transplant Neutrophil Nadir to Neutrophil Recover | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Days From Transplant to Platelet Count Recovery | Time (in days) from transplant to the first day of a platelet count of ≥20,000 per μL without a prior platelet transfusion in the preceding seven days. Low platelet numbers is associated with increased risk of bleeding and bruising. A healthy person has a platelet count ranging from 150,000 to 450,000 platelets per microliter of blood. | Transplanted Per Protocol Participants | Posted | | Mean | Standard Deviation | Days | | Transplant to Platelet Count Recovery | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed | Number of transplanted participants who remained off immunosuppression for ≥52 weeks, including those in whom the 52 week biopsy was not performed. This outcome included participants who were able to withdrawal successfully from all immunosuppression medication and remain off all immunosuppression for 52 weeks after the completion of withdrawal. | Transplanted Per Protocol Participants | Posted | | Count of Participants | | Participants | | Transplant to 52 Weeks after Discontinuation of All Immunosuppression | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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| Secondary | Number of Participants Free From Return to Immunosuppression for the Duration of the Study | Participants who were able to withdrawal successfully from all immunosuppression medication and remained off all immunosuppression medication for the remainder of the study. | Transplanted Per Protocol Participants | Posted | | Count of Participants | | Participants | | Transplant to End of Study (Up to 25 Months) | | | | ID | Title | Description |
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| OG000 | Enrolled, Transplanted | Participants were consented, enrolled, and fulfilled all study criteria. Participants received three .5, 2, and 2 mg/kg doses of ATG (7-9 days before transplant) pre-medicated with 650 mg acetaminophen, 25 mg diphenhydramine and steroid taper of methylprednisolone, five 30 mg/m^2/day doses of fludarabine (2-6 days before transplant), and two 14.5 mg/kg/day doses of low-dose cyclophosphamide (5-6 days before transplant), along with total body irradiation the day before transplant. Participants received a living renal transplant followed by bone marrow infusion. Two 50 mg/kg/day doses of high-dose cyclophosphamide were given days 3 and 4 post-transplant with MESNA. Filgrastim was given starting on day 5 post-transplant until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone began on day 5 post-transplant and given for at least 26 weeks post-transplant. Eligible participants were gradually withdrawn from medication over a period of 24-40 weeks. |
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