Trial Outcomes & Findings for Research Study of ATG and Rituximab in Renal Transplantation (NCT NCT01318915)

NCT ID: NCT01318915

Last Updated: 2018-11-29

Results Overview

Participants are considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least 52 weeks without evidence of rejection, as determined by a biopsy performed 52 weeks after completion of immunosuppression withdrawal. All participants who failed to complete immunosuppression withdrawal, regardless of reason, or failed to have a biopsy 52 weeks after completion of immunosuppression withdrawal, were considered to have failed. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

• Recruitment status: TERMINATED
• Study phase: EARLY_PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: Transplantation through 52 weeks after discontinuation of all immunosuppression
• Results posted on: 2018-11-29

Participant Flow

Participant milestones

Measure	Induction (Rituximab and ATG) Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Induction (Rituximab and ATG) Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Overall Study Lost to Follow-up

1

Baseline Characteristics

Research Study of ATG and Rituximab in Renal Transplantation

Baseline characteristics by cohort

Measure	Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	36.6 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants
Serum Creatinine	1.7 mg/dL STANDARD_DEVIATION 0.73 • n=5 Participants
eGFR	55.1 mg/dL STANDARD_DEVIATION 20.79 • n=5 Participants
Systolic Blood Pressure	142.3 mmHg STANDARD_DEVIATION 21.27 • n=5 Participants
Diastolic Blood Pressure	82.5 mmHg STANDARD_DEVIATION 15.01 • n=5 Participants
Total Cholesterol	181.6 mg/dL STANDARD_DEVIATION 67.10 • n=5 Participants
Glucose	102.0 mg/dL STANDARD_DEVIATION 22.57 • n=5 Participants

PRIMARY outcome

Timeframe: Transplantation through 52 weeks after discontinuation of all immunosuppression

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study

Participants are considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least 52 weeks without evidence of rejection, as determined by a biopsy performed 52 weeks after completion of immunosuppression withdrawal. All participants who failed to complete immunosuppression withdrawal, regardless of reason, or failed to have a biopsy 52 weeks after completion of immunosuppression withdrawal, were considered to have failed. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

Outcome measures

Measure

Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Participants Successfully Withdrawn From Immunosuppression and Remained Off Immunosuppression for at Least 52 Weeks

20 Percent of participants Interval 2.5 to 55.6

SECONDARY outcome

Timeframe: Transplantation through 52 weeks after discontinuation of all immunosuppression

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study

Participants are considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least 52 weeks without evidence of rejection. A biopsy performed 52 weeks after completion of immunosuppression withdrawal confirmed that there was no sub-clinical evidence of rejection. This result considers a participant off all immunosuppression for at least 52 weeks with or without the confirmatory week 52 biopsy as a success. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

Outcome measures

Measure

Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Transplanted Participants Who Remain Off Immunosuppression for at Least 52 Weeks Including Those in Whom the 52 Week Biopsy Was Not Performed

20 Percent of participants Interval 2.5 to 55.6

SECONDARY outcome

Timeframe: Transplantation through study completion (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study

Participants that remained off all immunosuppression through the completion of study participation. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

Outcome measures

Measure

Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Transplanted Participants Who Remain Off Immunosuppression for the Duration of the Study as Defined as Completion of All Schedules of Events/Followed Through August 25, 2017

10 Percent of participants Interval 0.3 to 44.5

SECONDARY outcome

Timeframe: Transplantation through 52 weeks post-transplantation

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study that tolerated sirolimus

Participants that were treated with only sirolimus within 52 weeks after transplantation in those who could tolerant sirolimus. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

Outcome measures

Measure

Induction (Rituximab and ATG) n=7 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Transplanted Participants Who Achieve Sirolimus Monotherapy Within 52 Weeks Post-transplant

86 Percent of participants Interval 42.1 to 99.6

SECONDARY outcome

Timeframe: Transplantation through 52 weeks post-transplantation

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study that could not tolerate sirolimus

Participants that were treated with only mycophenolate mofetil (MMF) or mycophenolic acid within 52 weeks after transplantation in those who could not tolerate sirolimus. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

Outcome measures

Measure

Induction (Rituximab and ATG) n=3 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Transplanted Participants Who Achieve MMF or Mycophenolic Acid Monotherapy Within 52 Weeks Post-transplant in Those Participants Intolerant of Sirolimus

33 Percent of participants Interval 0.8 to 90.6

SECONDARY outcome

Timeframe: Transplantation through 52 weeks post-transplantation

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study

Participants that were treated with only sirolimus or treated with only mycophenolate mofetil (MMF) or mycophenolic acid within 52 weeks after transplantation. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

Outcome measures

Measure

Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Transplanted Participants Who Achieve Either Sirolimus Monotherapy or Monotherapy on a Mycophenolic Compound Within 52 Weeks Post-transplant

70 Percent of participants Interval 34.8 to 93.3

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study that stopped using all immunosuppression drugs

Time (in days) from when the participant is off all immunosuppression to the end of trial participation or re-initiation of immunosuppression, whichever is earliest.

Outcome measures

Measure

Induction (Rituximab and ATG) n=6 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Immunosuppression-free Duration in Days, Defined as Time From Completion of Immunosuppression Withdrawal to End of Trial Participation or to Time of Restarting Immunosuppression

374 Days Interval 198.0 to 639.0

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study that stopped using all immunosuppression drugs and had acute rejection or presumed acute rejection.

Time (in days) from when the participant is off all immunosuppression to the first episode of biopsy proven or presumed acute rejection.

Outcome measures

Measure

Induction (Rituximab and ATG) n=5 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Time From Completion of Immunosuppression Withdrawal to First Episode of Acute Rejection or Presumed Acute Rejection

380 Days Interval 198.0 to 452.0

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study that stopped using all immunosuppression drugs and were diagnosed with chronic rejection.

Time (in days) from the time the participant is off all immunosuppression to the first episode of chronic T cell mediated or chronic antibody-mediated rejection. This assessment also includes progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy without an alternative, non-rejection related cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study.

A participant is considered to have graft loss when the donated kidney needs to be removed, the participant is retransplanted with another donor kidney, or chronic dialysis is instituted. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

Outcome measures

Measure

Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Transplanted Participants With Graft Loss

0 Percent of participants Interval 0.0 to 30.9

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study

Death after receiving a kidney transplant. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

Outcome measures

Measure

Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Transplant Participants Who Died

0 Percent of participants Interval 0.0 to 30.9

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study.

Participants with either biopsy proven acute rejection per Banff guidelines or participants that were treated for acute rejection in the absence of a biopsy. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

Outcome measures

Measure

Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Transplanted Participants With Acute Rejection or Presumed Acute Rejection

90 Percent of participants Interval 55.5 to 99.8

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study.

Biopsy-confirmed 1.) acute cellular rejection and 2.) acute antibody-mediated rejection was classified according to Banff 2007 criteria of renal allograft pathology for renal allograft rejection. A Banff result of indeterminate was not classified as rejection.

Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection is defined as a grade ≥ IA. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe.

Acute antibody-mediated rejection-or humoral rejection-is defined as a grade ≥1. Severity is graded as I, II, or III, with I being the mildest form of antibody-mediated rejection and III being the most severe.

Outcome measures

Measure	Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Histological Severity of Biopsies Demonstrating Acute Rejection as Measured by Banff 2007 Grade Acute Cellular Rejection (Type IIA)	0 Biopsies
Histological Severity of Biopsies Demonstrating Acute Rejection as Measured by Banff 2007 Grade Acute Cellular Rejection (Type III)	0 Biopsies
Histological Severity of Biopsies Demonstrating Acute Rejection as Measured by Banff 2007 Grade Acute Antibody-Mediated Rejection (Type I)	0 Biopsies
Histological Severity of Biopsies Demonstrating Acute Rejection as Measured by Banff 2007 Grade Acute Antibody-Mediated Rejection (Type III)	0 Biopsies
Histological Severity of Biopsies Demonstrating Acute Rejection as Measured by Banff 2007 Grade Acute Cellular Rejection (Type IA)	7 Biopsies
Histological Severity of Biopsies Demonstrating Acute Rejection as Measured by Banff 2007 Grade Acute Cellular Rejection (Type IB)	3 Biopsies
Histological Severity of Biopsies Demonstrating Acute Rejection as Measured by Banff 2007 Grade Acute Cellular Rejection (Type IIB)	0 Biopsies
Histological Severity of Biopsies Demonstrating Acute Rejection as Measured by Banff 2007 Grade Acute Antibody-Mediated Rejection (Type II)	0 Biopsies

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study.

This assessment included participants who experienced chronic T cell-mediated rejection or chronic antibody mediated rejection as well as progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy without an alternative, non-rejection-related cause.

Outcome measures

Measure

Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Participants With Chronic T Cell-mediated or Antibody-mediated Rejection

0 Percent of participants Interval 0.0 to 30.9

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study that had acute rejection requiring treatment.

Time (in days) from transplant to the start date of the first dose of treatment for acute rejection. This includes acute rejection episodes requiring treatment that are not biopsy proven.

Outcome measures

Measure

Induction (Rituximab and ATG) n=6 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Time From Transplant to the First Episode of Acute Rejection Requiring Treatment

1008.5 Days Interval 577.0 to 1139.0

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study.

Anti-lymphocyte therapy is a drug that targets specific cells in the immune system called lymphocytes (white blood cells). This therapy helps stop the participant's immune system from attacking the donor kidney. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.

Outcome measures

Measure

Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.

Percent of Participants Requiring Anti-lymphocyte Therapy (OKT3, ATG) for an Acute Rejection Event

20 Percent of participants Interval 2.5 to 55.6

SECONDARY outcome

Timeframe: Transplantation through end of trial participation (up to 4.4 years post-transplant)

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study

Adverse events that are reported as being a post-transplant infection, wound complication, lymphocoele (a collection of fluid in the lymphatic system), post-transplant diabetes mellitus or malignancy.

Outcome measures

Measure	Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Number of Adverse Events, Including Number of Post-transplant Infections, Wound Complications, Lymphocoele, Post-transplant Diabetes Mellitus, and Malignancies Post-Transplant Infection	4 Events
Number of Adverse Events, Including Number of Post-transplant Infections, Wound Complications, Lymphocoele, Post-transplant Diabetes Mellitus, and Malignancies Wound Complications	1 Events
Number of Adverse Events, Including Number of Post-transplant Infections, Wound Complications, Lymphocoele, Post-transplant Diabetes Mellitus, and Malignancies Lymphocoele	0 Events
Number of Adverse Events, Including Number of Post-transplant Infections, Wound Complications, Lymphocoele, Post-transplant Diabetes Mellitus, and Malignancies Post-Transplant Diabetes Mellitus	0 Events
Number of Adverse Events, Including Number of Post-transplant Infections, Wound Complications, Lymphocoele, Post-transplant Diabetes Mellitus, and Malignancies Malignancy	0 Events

SECONDARY outcome

Timeframe: 26, 52, 104, 156, and 208 Weeks Post-Transplant

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. A value less than 15 indicates kidney failure, 15 to 29 indicates severe loss of kidney function, 30 to 44 indicates moderate to severe loss of kidney function, 45 to 59 mild to moderate loss of kidney function, 60 to 89 indicates mild loss of kidney function, and 90 or higher indicates normal kidney function. The equation developed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) is used to estimate GFR from serum creatinine. The value closest to and within 6 weeks of the day expected was selected.

Outcome measures

Measure	Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Participant Renal Function as Measured by GFR Using CKD-EPI 26 Weeks Post-Transplant	60.3 mL/min/1.73m^2 Interval 57.1 to 64.3
Participant Renal Function as Measured by GFR Using CKD-EPI 52 Weeks Post-Transplant	70.9 mL/min/1.73m^2 Interval 57.0 to 74.6
Participant Renal Function as Measured by GFR Using CKD-EPI 156 Weeks Post-Transplant	56.7 mL/min/1.73m^2 Interval 54.9 to 85.6
Participant Renal Function as Measured by GFR Using CKD-EPI 104 Weeks Post-Transplant	63.7 mL/min/1.73m^2 Interval 58.6 to 69.5
Participant Renal Function as Measured by GFR Using CKD-EPI 208 Weeks Post-Transplant	56.0 mL/min/1.73m^2 Interval 37.5 to 94.1

SECONDARY outcome

Timeframe: 26, 52, 104, 156, and 208 Weeks Post-Transplant

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.

Systolic blood pressure measures the pressure on the blood vessels when the heart is beats and thus is pushing blood to the rest of the body. A normal systolic blood pressure is lower than 120 mmHg. High blood pressure, as known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged. The value closest to and within 6 weeks of the day expected was selected.

Outcome measures

Measure	Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Participant Systolic Blood Pressure Over Time 26 Weeks Post-Transplant	131.5 mmHg Interval 123.0 to 140.0
Participant Systolic Blood Pressure Over Time 52 Weeks Post-Transplant	135 mmHg Interval 130.0 to 140.0
Participant Systolic Blood Pressure Over Time 104 Weeks Post-Transplant	137 mmHg Interval 135.0 to 148.0
Participant Systolic Blood Pressure Over Time 156 Weeks Post-Transplant	140 mmHg Interval 120.0 to 140.0
Participant Systolic Blood Pressure Over Time 208 Weeks Post-Transplant	132 mmHg Interval 123.5 to 135.0

SECONDARY outcome

Timeframe: 26, 52, 104, 156, and 208 Weeks Post-Transplant

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.

Diastolic blood pressure measures the pressure in the arteries when the heart is at rest and is thus filled with blood. A normal diastolic blood pressure is lower than 80 mmHg. High blood pressure, as known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged. The value closest to and within 6 weeks of the day expected was selected.

Outcome measures

Measure	Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Participant Diastolic Blood Pressure Over Time 26 Weeks Post-Transplant	77.5 mmHg Interval 71.0 to 86.0
Participant Diastolic Blood Pressure Over Time 52 Weeks Post-Transplant	77 mmHg Interval 74.0 to 88.0
Participant Diastolic Blood Pressure Over Time 104 Weeks Post-Transplant	79 mmHg Interval 72.0 to 88.0
Participant Diastolic Blood Pressure Over Time 156 Weeks Post-Transplant	76 mmHg Interval 58.0 to 92.0
Participant Diastolic Blood Pressure Over Time 208 Weeks Post-Transplant	73 mmHg Interval 66.5 to 79.5

SECONDARY outcome

Timeframe: 26, 52, 104, 156, and 208 Weeks Post-Transplant

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.

Total cholesterol measures the amount of cholesterol found in the blood. Cholesterol is a waxy substance your body needs to build cells, but too much can be a problem since it can build-up in arteries. Narrowed arteries can result in heart attack or stroke. A value less than 200 mg/dL is considered good. The value closest to and within 12 weeks of the day expected was selected.

Outcome measures

Measure	Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Participant Total Cholesterol Over Time 52 Weeks Post-Transplant	141.5 mg/dL Interval 129.5 to 170.0
Participant Total Cholesterol Over Time 208 Weeks Post-Transplant	173 mg/dL Interval 118.0 to 285.0
Participant Total Cholesterol Over Time 26 Weeks Post-Transplant	188 mg/dL Interval 168.0 to 215.5
Participant Total Cholesterol Over Time 104 Weeks Post-Transplant	165 mg/dL Interval 149.0 to 172.0
Participant Total Cholesterol Over Time 156 Weeks Post-Transplant	175 mg/dL Interval 153.0 to 199.0

SECONDARY outcome

Timeframe: 26, 52, 104, 156, and 208 Weeks Post-Transplant

Population: Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.

This is a measure of glucose found in the blood. Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. Fasting levels for glucose should be around 70-99 mg/dL and less than 140 mg/dL within 2 hours after a meal. The value closest to and within 6 weeks of the day expected was selected.

Outcome measures

Measure	Induction (Rituximab and ATG) n=10 Participants Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m\^2. The first dose of rituximab was given \~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Participant Glucose Level Over Time 26 Weeks Post-Transplant	103.5 mg/dL Interval 96.0 to 112.0
Participant Glucose Level Over Time 156 Weeks Post-Transplant	104.5 mg/dL Interval 94.0 to 208.0
Participant Glucose Level Over Time 52 Weeks Post-Transplant	108 mg/dL Interval 90.0 to 116.0
Participant Glucose Level Over Time 104 Weeks Post-Transplant	96.5 mg/dL Interval 83.0 to 129.0
Participant Glucose Level Over Time 208 Weeks Post-Transplant	83.5 mg/dL Interval 75.5 to 141.0

Adverse Events

Transplanted

Serious events: 7 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Transplanted n=10 participants at risk These are adult living donor kidney transplant recipients that were enrolled into the study prior to transplant and met all criteria for study participation. These participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m2. The first dose of rituximab was given around day -6 prior to transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on the anti-rejection medications tacrolimus, MMF, and sirolimus after transplant. Participants were evaluated for eligibility to start gradual withdrawal of their anti-rejection medications starting as early as 26 weeks post-transplant. Eligible participants were gradually withdrawn from anti-rejection medication over a period of 68-104 weeks.
Gastrointestinal disorders Abdominal hernia	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Immune system disorders Transplant rejection	40.0% 4/10 • Number of events 4 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Infections and infestations Pyelonephritis	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Injury, poisoning and procedural complications Incisional hernia	20.0% 2/10 • Number of events 2 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Injury, poisoning and procedural complications Seroma	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Injury, poisoning and procedural complications Toxicity to various agents	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Nervous system disorders Cerebrovascular accident	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Renal and urinary disorders Nephrolithiasis	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Renal and urinary disorders Renal injury	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Vascular disorders Deep vein thrombosis	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).

Other adverse events

Measure	Transplanted n=10 participants at risk These are adult living donor kidney transplant recipients that were enrolled into the study prior to transplant and met all criteria for study participation. These participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m2. The first dose of rituximab was given around day -6 prior to transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on the anti-rejection medications tacrolimus, MMF, and sirolimus after transplant. Participants were evaluated for eligibility to start gradual withdrawal of their anti-rejection medications starting as early as 26 weeks post-transplant. Eligible participants were gradually withdrawn from anti-rejection medication over a period of 68-104 weeks.
Blood and lymphatic system disorders Leukopenia	20.0% 2/10 • Number of events 6 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Blood and lymphatic system disorders Neutropenia	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Cardiac disorders Aortic valve incompetence	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Endocrine disorders Hyperparathyroidism secondary	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Gastrointestinal disorders Mouth ulceration	20.0% 2/10 • Number of events 2 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Gastrointestinal disorders Stomatitis	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
General disorders Oedema peripheral	20.0% 2/10 • Number of events 2 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Immune system disorders Transplant rejection	20.0% 2/10 • Number of events 2 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Infections and infestations BK virus infection	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Infections and infestations Cytomegalovirus viraemia	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Infections and infestations Viraemia	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Investigations Blood creatinine increased	20.0% 2/10 • Number of events 4 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Investigations Eosinophil count increased	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Investigations Lymphocyte count decreased	20.0% 2/10 • Number of events 5 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Investigations Transaminases increased	20.0% 2/10 • Number of events 2 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Investigations White blood cell count decreased	30.0% 3/10 • Number of events 3 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Metabolism and nutrition disorders Hyperglycaemia	30.0% 3/10 • Number of events 3 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Metabolism and nutrition disorders Hyperkalaemia	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Metabolism and nutrition disorders Hypoalbuminaemia	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Metabolism and nutrition disorders Hyponatraemia	20.0% 2/10 • Number of events 4 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Metabolism and nutrition disorders Hypophosphataemia	20.0% 2/10 • Number of events 2 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Nervous system disorders Paraesthesia	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Renal and urinary disorders IgA nephropathy	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Renal and urinary disorders Nephropathy	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Renal and urinary disorders Proteinuria	20.0% 2/10 • Number of events 2 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Vascular disorders Hypertension	20.0% 2/10 • Number of events 3 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Vascular disorders Varicose vein	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).
Vascular disorders Venous insufficiency	10.0% 1/10 • Number of events 1 • Transplantation through end of trial participation (up to 4.4 years post-transplant).

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: DAITClinicalTrialsGov@niaid.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place