Renal Allograft Tolerance Through Mixed Chimerism
This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
David Sachs M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01780454
First received: January 29, 2013
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
End Stage Renal Disease |
Drug: MEDI-507 Drug: Rituximab Radiation: Total Body Irradiation Radiation: Thymic Irradiation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Renal Allograft Tolerance Through Mixed Chimerism |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Successful withdrawal of immunosuppressive therapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]The primary endpoint is induction of transient mixed chimerism and renal allograft tolerance without "engraftment syndrome" or "acute kidney injury"
Secondary Outcome Measures:
- Incidence of Engraftment Syndrome [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 2 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Drug: MEDI-507
T-Cell Depleting Agent
Drug: Rituximab
B-Cell Depleting Agent
Radiation: Total Body Irradiation
Bone Marrow Depletion
Radiation: Thymic Irradiation
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key 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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780454
Contacts
| Contact: Kerry Crisalli, RN | 617-643-4087 | kcrisalli@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | A. Benedict Cosimi, M.D. | Massachusetts General Hospital |
| Principal Investigator: | David Sachs, M.D. | Massachusetts General Hospital |
More Information
Publications:
| Responsible Party: | David Sachs M.D., Director, Transplantation Biology Research Center, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01780454 History of Changes |
| Other Study ID Numbers: | 2013P000822 |
| Study First Received: | January 29, 2013 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
End Stage Renal Disease Renal Transplant Bone Marrow Transplant |
Tolerance Chimerism ESRD |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Rituximab |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013