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Renal Allograft Tolerance Through Mixed Chimerism

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ClinicalTrials.gov Identifier: NCT01780454
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : September 23, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
David Sachs M.D., Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition End Stage Renal Disease
Interventions Drug: MEDI-507
Drug: Rituximab
Radiation: Total Body Irradiation
Radiation: Thymic Irradiation
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combined Bone Marrow and Kidney Transplantation
Hide Arm/Group Description

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

Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Combined Bone Marrow and Kidney Transplantation
Hide Arm/Group Description

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 Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
1
  50.0%
Not Hispanic or Latino
1
  50.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Successful Withdrawal of Immunosuppressive Therapy
Hide Description The primary endpoint is induction of transient mixed chimerism and renal allograft tolerance without "engraftment syndrome" or "acute kidney injury"
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Bone Marrow and Kidney Transplantation
Hide Arm/Group Description:

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 Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
2.Secondary Outcome
Title Number of Participants With Engraftment Syndrome
Hide Description Constellation of symptoms known "Engraftment Syndrome"
Time Frame 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Bone Marrow and Kidney Transplantation
Hide Arm/Group Description:

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 Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combined Bone Marrow and Kidney Transplantation
Hide Arm/Group Description

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

All-Cause Mortality
Combined Bone Marrow and Kidney Transplantation
Affected / at Risk (%)
Total   0/2 (0.00%)    
Hide Serious Adverse Events
Combined Bone Marrow and Kidney Transplantation
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Gastrointestinal disorders   
Dehydration   1/2 (50.00%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Combined Bone Marrow and Kidney Transplantation
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia   2/2 (100.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Sachs
Organization: Massachusetts General Hospital
Phone: 617-726-4065
EMail: David.Sachs@tbrc.mgh.harvard.edu
Layout table for additonal information
Responsible Party: David Sachs M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01780454    
Other Study ID Numbers: 2013P000822
First Submitted: January 29, 2013
First Posted: January 31, 2013
Results First Submitted: September 1, 2020
Results First Posted: September 23, 2020
Last Update Posted: April 19, 2021