Trial Outcomes & Findings for Renal Allograft Tolerance Through Mixed Chimerism (NCT NCT01780454)

Last Updated: 2021-04-19

Results Overview

The primary endpoint is induction of transient mixed chimerism and renal allograft tolerance without "engraftment syndrome" or "acute kidney injury"

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

5 years

Results posted on

2021-04-19

Participant milestones
Measure	Combined Bone Marrow and Kidney Transplantation Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation MEDI-507: T-Cell Depleting Agent Rituximab: B-Cell Depleting Agent Total Body Irradiation: Bone Marrow Depletion Thymic Irradiation
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Renal Allograft Tolerance Through Mixed Chimerism

Baseline characteristics by cohort
Measure	Combined Bone Marrow and Kidney Transplantation n=2 Participants Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation MEDI-507: T-Cell Depleting Agent Rituximab: B-Cell Depleting Agent Total Body Irradiation: Bone Marrow Depletion Thymic Irradiation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 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	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

Timeframe: 5 years

The primary endpoint is induction of transient mixed chimerism and renal allograft tolerance without "engraftment syndrome" or "acute kidney injury"

Outcome measures
Measure	Combined Bone Marrow and Kidney Transplantation n=2 Participants Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation MEDI-507: T-Cell Depleting Agent Rituximab: B-Cell Depleting Agent Total Body Irradiation: Bone Marrow Depletion Thymic Irradiation
Successful Withdrawal of Immunosuppressive Therapy	2 Participants

Timeframe: 5 Years

Constellation of symptoms known "Engraftment Syndrome"

Outcome measures
Measure	Combined Bone Marrow and Kidney Transplantation n=2 Participants Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation MEDI-507: T-Cell Depleting Agent Rituximab: B-Cell Depleting Agent Total Body Irradiation: Bone Marrow Depletion Thymic Irradiation
Number of Participants With Engraftment Syndrome	2 Participants

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events
Measure	Combined Bone Marrow and Kidney Transplantation n=2 participants at risk Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation MEDI-507: T-Cell Depleting Agent Rituximab: B-Cell Depleting Agent Total Body Irradiation: Bone Marrow Depletion Thymic Irradiation
Gastrointestinal disorders Dehydration	50.0% 1/2 • Number of events 1 • 5 years

Other adverse events
Measure	Combined Bone Marrow and Kidney Transplantation n=2 participants at risk Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation MEDI-507: T-Cell Depleting Agent Rituximab: B-Cell Depleting Agent Total Body Irradiation: Bone Marrow Depletion Thymic Irradiation
Blood and lymphatic system disorders Neutropenia	100.0% 2/2 • Number of events 2 • 5 years

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