At a glance
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Renal Allograft Tolerance Through Mixed Chimerism
In Brief
A Phase 2 clinical trial evaluating Kidney Transplantation, Bone marrow transplantation, and 6 other interventions for Kidney Transplantation and Kidney Failure, Chronic. Completed, enrolled 5 participants across 1 site.
Detailed 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.
Study Details
Timeline
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