Tolerance Induction in Living Donor Kidney Transplantation With Hematopoietic Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT02199301|
Recruitment Status : Unknown
Verified September 2012 by Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : July 24, 2014
Last Update Posted : July 24, 2014
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 IS will be tapered slowly and withdrawn over a period of several months.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Procedure: Transplantation Conditioning for BMT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tolerance Induction in Living Donor Kidney Transplantation With Hematopoietic Stem Cell Transplantation|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2017|
Transplantation Conditioning for bone marrow transplantation (BMT) Kidney transplantation and BMT (BMTKT)
Procedure: Transplantation Conditioning for BMT
Transplantation Conditioning for BMT (POD#-7~-1) POD#-7: Rituximab (Mabthera, Roche Pharma Aktiengesellschaft (AG) Swiss) 375/m2 iv infusion POD#-6~-3: Fludarabine (Fludara Inj., Bayer AG, Germany) 30mg/m2/day iv infusion POD#-5~-4: Cyclophosphamide (Endoxan Inj., Baxter Oncology Gesellschaft mit beschränkter Haftung (GmbH), Germany) 30mg/kg/day iv infusion POD#-2: (Rituximab 375/m2 iv infusion) POD#-1: Thymic irradiation (Dose, 700cGy)
- Immune Suppression Withdrawal [ Time Frame: 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.
- Graft failure [ Time Frame: 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 [ Time Frame: 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.
- Microchimerism [ Time Frame: At post-transplantation 1, 2, 3, 4, 8, and 24 wks ]Presence and proportion of microchimerism in recipient's peripheral blood will be measured by microsatellite short tandem repeat.
- Immune Cell Profiling [ Time Frame: At post-transplantation 1, 2, 4, 8, 12, 24, and 52 weeks ]Changes of proportion or absolute count of immune cells are measured by flowcytometric analysis in recipient's peripheral blood, using cluster of differentiation (CD) marker.
- Mixed Lymphocyte Reaction [ Time Frame: At post-transplantation 8, 24, 52 weeks ]Mixed lymphocyte reaction will be done for the evaluation for the donor-specific immune response (Donor vs. 3rd party) in vitro.
- Protocol Biopsy [ Time Frame: Post-transplantation 3, 24, and 52 weeks ]Absence or presence of allograft rejection is confirmed by ultrasonography-guided percutaneous biopsy during follow-up and prior to withdrawal of immunosuppressive agent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199301
|Contact: Sung Joo Kim, MD, PhDemail@example.com|
|Contact: Jae Berm Park, MD, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center, Organ Transplant Center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Sung Joo Kim, MD, PhD 82-2-3410-3476 email@example.com|
|Contact: Jae Berm Park, MD, PhD 82-2-3410-3647 firstname.lastname@example.org|
|Principal Investigator: Sung Joo Kim, MD, PhD|
|Sub-Investigator: Jae Berm Park, MD, PhD|