Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection
Renal Allograft Tolerance Through Mixed Chimerism
1 other identifier
interventional
5
1 country
1
Brief Summary
In small initial studies, combined kidney and bone marrow transplants from the same donor have permitted some individuals to stop taking anti-rejection medicines without rejecting their transplant. This clinical trial will study this method in a greater number of people to determine if it is indeed effective and safe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
May 12, 2015
CompletedNovember 10, 2015
November 1, 2015
5.3 years
December 2, 2008
April 21, 2015
November 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks
A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first.
48 months post-transplant
Secondary Outcomes (7)
Percentage of Participants Experiencing Acute Rejection
Transplantation until study completion or participant termination (up to five years)
Change in Renal Function
Transplantation until study completion or participant termination (up to five years)
Percentage of Participants With Graft Survival Through 156 Weeks
Transplantation until week 156
Percentage of Participants Surviving Through 156 Weeks
Transplantation until week 156
Time to Neutrophil Recovery Following Transplant
Transplantation until study completion or participant termination (participants followed up to five years)
- +2 more secondary outcomes
Study Arms (1)
Kidney and Marrow Recipients
EXPERIMENTALCombined kidney and bone marrow transplant
Interventions
Surgical transplantation of donor kidney
During kidney transplant, bone marrow cells donated by the same donor as the kidney are given through a plastic tube placed in a vein in the chest, underneath the collarbone
0.1 mg/kg on day -2; 0.6 mg/kg on days -1,0,1
60 mg/kg infusion on days -5, -4
375 mg/m\^2 infusion on days -7, -2, 5, and 12
0.05 mg/kg intravenously twice daily starting on day -1, adjusted to trough level of 10-15ng/ml, then tapered (if eligible) on days 1, 7, 14, 21, 28, 42, and 56
2 mg/kg prednisone on day 4, with an additional 500-mg pulse of methylprednisolone given on days 10, 11, and 12, and then tapered off by day 20
700 cGy of thymic irradiation administered in a single dose on day -1
Eligibility Criteria
You may qualify if:
- Awaiting first or second transplant with a living donor or first transplant with a cadaveric donor
- For living-donor transplants, must have one or more HLA antigen-mismatched donors identified
- Serologic evidence of prior exposure to Epstein-Barr virus (EBV)
You may not qualify if:
- ABO blood group-incompatibility for a kidney graft of tissue from a donor
- Decreased circulating white blood cell count
- Positive for HIV-1, hepatitis B and C viruses
- Have had prior radiation therapy that could limit dose
- Lung capacity \<50% of predicted normal
- Evidence of insufficient cardiac capacity
- Unwilling to use adequate contraception until 2 years after transplant
- Lactation or pregnancy
- Presence of antibody against the donor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
Kawai T, Cosimi AB, Spitzer TR, Tolkoff-Rubin N, Suthanthiran M, Saidman SL, Shaffer J, Preffer FI, Ding R, Sharma V, Fishman JA, Dey B, Ko DS, Hertl M, Goes NB, Wong W, Williams WW Jr, Colvin RB, Sykes M, Sachs DH. HLA-mismatched renal transplantation without maintenance immunosuppression. N Engl J Med. 2008 Jan 24;358(4):353-61. doi: 10.1056/NEJMoa071074.
PMID: 18216355BACKGROUNDKawai T, Sachs DH, Sykes M, Cosimi AB; Immune Tolerance Network. HLA-mismatched renal transplantation without maintenance immunosuppression. N Engl J Med. 2013 May 9;368(19):1850-2. doi: 10.1056/NEJMc1213779. No abstract available.
PMID: 23656665RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research Program
- Organization
- DAIT/NIAID
Study Officials
- PRINCIPAL INVESTIGATOR
David Sachs, MD
Massacusetts General Hospital
- PRINCIPAL INVESTIGATOR
Ben Cosimi, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 3, 2008
Study Start
December 1, 2008
Primary Completion
April 1, 2014
Study Completion
November 1, 2014
Last Updated
November 10, 2015
Results First Posted
May 12, 2015
Record last verified: 2015-11