Tolerance Induction in Living Donor Kidney Transplantation With Hematopoietic Stem Cell Transplantation
- Conditions
- End Stage Renal Disease
- Interventions
- Procedure: Transplantation Conditioning for BMT
- Registration Number
- NCT02199301
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Kidney transplantation (KT) requires a life-long immune suppression (IS). It has been well-known that long-term IS inevitably causes various complication e.g. infection, toxicity, diabetes, osteoporosis, avascular necrosis of hip joint, cataract, acne, and malignancies and so on. Tolerance induction showing graft function without maintenance IS has been considered as a final solution in the transplantation recipients. Tolerance induction can be achieved in KT recipients with donor hematopoietic stem cell transplantation (HSCT).
In this study, adult patients (18 and more years of age) with a human leukocyte antigen (HLA)-haplotype match donor are enrolled. Patients receive preconditioning treatment for HSCT 1week prior to KT. Bone marrow is harvested from donor under general anesthesia at the time of nephrectomy for transplantation in donor. Donor BM is infused immediate post-transplantation at intensive care unit (ICU). Immunologic measurements including microchimerism study and protocol biopsy will be followed at several time points. IS will be tapered slowly and withdrawn over a period of several months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6
- All consenting adult (18 and more years of age) living donor kidney transplant recipients who have a one haplotype match donor.
- Patients who have no known contraindication to administration of rabbit anti-thymocyte globulin (ATG) or radiation.
- Patients who agree to participate in the study and sign an Informed Consent.
- Presence of previous episode of transplantation including kidney
- Simultaneous multi-visceral transplantation
- Demonstration of donor specific antibody (DSA) or panel reactive antibody(PRA) greater than 20%
- ABO blood type incompatible
- Previous treatment with rabbit anti-thymocyte globulin or a known allergy to rabbit proteins.
- History of malignancy with the exception of non-melanoma skin malignancies.
- Uncontrolled systemic or concomitant unstable infection
- Serological evidence of Hepatitis B or Hepatitis C or HIV infection.
- Severe psychiatric disease
- Leukopenia (with a white blood cell count < 3000/mm3)
- Disagreement to participate in the study and sign an Informed Consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMTKT Transplantation Conditioning for BMT Transplantation Conditioning for bone marrow transplantation (BMT) Kidney transplantation and BMT (BMTKT)
- Primary Outcome Measures
Name Time Method Immune Suppression Withdrawal Immune Suppression Withdrawal within 18 months post-transplantation Immune suppression will be tapered-off and withdrawn over the period of 6 to 18 months post-transplantation under the monitoring of graft function and immunologic measurements.
- Secondary Outcome Measures
Name Time Method Graft failure At the post-transplantation 18 months In this study, immune suppression(IS) will be tapered-off and withdrawn over the period of 6 to 18 months post-transplantation under the monitoring of graft function and immunologic measurements. At the post-transplantation 18 months we evaluate graft failure episode irrespective of IS withdrawal.
Allograft Rejection At the post-transplantation 18 months In this study, immune suppression(IS) will be tapered-off and withdrawn over the period of 6 to 18 months post-transplantation under the monitoring of graft function and immunologic measurements. At the post-transplantation 18 months we evaluate allograft rejection episode irrespective of IS withdrawal.
Trial Locations
- Locations (1)
Samsung Medical Center, Organ Transplant Center
🇰🇷Seoul, Korea, Republic of