End Stage Renal DiseaseNCT02199301
Tolerance Induction in Living Donor Kidney Transplantation With Hematopoietic Stem Cell Transplantation
A study testing Transplantation Conditioning for BMT in people with End Stage Renal Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Transplantation Conditioning for BMT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center, Organ Transplant Center
Seoul, 135-710
Sung Joo Kim, MD, PhD, 82-2-3410-3476, kmhyj.kim@samsung.com
Jae Berm Park, MD, PhD, 82-2-3410-3647, jbparkmd@gmail.com
About this study
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.
- Conditions
- End Stage Renal Disease
- Being tested
- Transplantation Conditioning for BMT
- Keywords
- Kidney transplantation, Tolerance induction, Immunosuppression withdrawal, Bone marrow transplantation, Transplantation conditioning, Hematopoietic stem cell transplantation, Living donor, Haplotype, Immune tolerance
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation Conditioning for BMTProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| BMTKT | Experimental | Transplantation Conditioning for bone marrow transplantation (BMT) Kidney transplantation and BMT (BMTKT) Receives: Procedure: Transplantation Conditioning for BMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Suppression Withdrawal
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.
Measured: Immune Suppression Withdrawal within 18 months post-transplantation
Secondary outcomes (2)
Graft failure
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.
Measured: At the post-transplantation 18 months
Allograft Rejection
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.
Measured: At the post-transplantation 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199301
- Sponsor's protocol ID
- 2010-07-210
- Status last verified
- Sep 2012
- First submitted
- 10 Sep 2012
- Last updated
- 24 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance Induction in Living Donor Kidney Transplantation With Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02199301
- Acronym / sponsor ID
- 2010-07-210
- Conditions
- End Stage Renal Disease
- Keywords
- Kidney transplantation, Tolerance induction, Immunosuppression withdrawal, Bone marrow transplantation, Transplantation conditioning, Hematopoietic stem cell transplantation, Living donor, Haplotype
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMTKT | Experimental | Procedure: Transplantation Conditioning for BMTTransplantation Conditioning for bone marrow transplantation (BMT) Kidney transplantation and BMT (BMTKT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transplantation Conditioning for BMTTransplantation 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) | Procedure or surgery | BMTKT |
Primary outcome
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.
2 secondary outcomes
Graft failure
Time frame: At the post-transplantation 18 months
Allograft Rejection
Time frame: At the post-transplantation 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transplantation Conditioning for BMT in people with End Stage Renal Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Joo Kim, MD, PhD (82-2-3410-3476, kmhyj.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Suppression Withdrawal (time frame: Immune Suppression Withdrawal within 18 months post-transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.