Tolerance Induction in Living Donor Kidney Transplantation With Hematopoietic Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-12-31

Brief Summary

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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 IS will be tapered slowly and withdrawn over a period of several months.

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMTKT

Transplantation Conditioning for bone marrow transplantation (BMT) Kidney transplantation and BMT (BMTKT)

Group Type EXPERIMENTAL

Transplantation Conditioning for BMT

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. All consenting adult (18 and more years of age) living donor kidney transplant recipients who have a one haplotype match donor.
2. Patients who have no known contraindication to administration of rabbit anti-thymocyte globulin (ATG) or radiation.
3. Patients who agree to participate in the study and sign an Informed Consent.

Exclusion Criteria

1. Presence of previous episode of transplantation including kidney
2. Simultaneous multi-visceral transplantation
3. Demonstration of donor specific antibody (DSA) or panel reactive antibody(PRA) greater than 20%
4. ABO blood type incompatible
5. Previous treatment with rabbit anti-thymocyte globulin or a known allergy to rabbit proteins.
6. History of malignancy with the exception of non-melanoma skin malignancies.
7. Uncontrolled systemic or concomitant unstable infection
8. Serological evidence of Hepatitis B or Hepatitis C or HIV infection.
9. Severe psychiatric disease
10. Leukopenia (with a white blood cell count \< 3000/mm3)
11. Disagreement to participate in the study and sign an Informed Consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No