Renal Allograft Tolerance Through Mixed Chimerism

Phase 1

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: MEDI-507; Drug: Rituximab; Radiation: Total Body Irradiation; Radiation: Thymic Irradiation

• Registration Number: NCT01780454
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a haplo-identical related donor. An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-31
• Study Start: 2013-03
• Primary Completion: 2018-06
• Study Completion: 2020-06
• Results First Submitted: 2020-09-01
• Results First Submitted QC: 2020-09-01
• Results First Posted: 2020-09-23
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Male or female 18-60 years of age
• Candidate for a living-donor renal allograft with a one haplotype identical donor identified.
• First or second transplant with either a living donor or cadaveric transplant as the first transplant.
• Positive serologic testing for EBV indicating past exposure.

Key

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Exclusion Criteria

• ABO blood group-incompatible renal allograft.
• Evidence of anti-HLA antibody within 60 days prior to transplant as assessed by routine methodology (AHG and/or ELISA)
• Positive testing for: HIV, hepatitis B core antigen, or hepatitis C virus or positivity for hepatitis B surface antigen.
• Cardiac ejection fraction < 40% or clinical evidence of insufficiency.
• History of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
• Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis, type I or II nonproliferative glomerulonephritis).
• Prior dose-limiting radiation therapy.
• Abnormal (>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT).
• The presence of any medical condition that the investigator deems incompatible with participation in the trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined Bone Marrow and Kidney Transplantation	Total Body Irradiation	Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation
Combined Bone Marrow and Kidney Transplantation	Thymic Irradiation	Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation
Combined Bone Marrow and Kidney Transplantation	MEDI-507	Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation
Combined Bone Marrow and Kidney Transplantation	Rituximab	Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation

Primary Outcome Measures

Name	Time	Method
Successful Withdrawal of Immunosuppressive Therapy	5 years	The primary endpoint is induction of transient mixed chimerism and renal allograft tolerance without "engraftment syndrome" or "acute kidney injury"

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Engraftment Syndrome	5 Years	Constellation of symptoms known "Engraftment Syndrome"

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States