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Effect of BM-MSCs in DCD Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT02561767
Recruitment Status : Unknown
Verified September 2015 by Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Not yet recruiting
First Posted : September 28, 2015
Last Update Posted : September 28, 2015
Sponsor:
Collaborator:
Second Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University

Study Description
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Brief Summary:
This study is designed to determine the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells in kidney transplantation from Chinese donation after citizen's death (DCD). A pair uremia patients receiving kidney grafts from a same donor are randomized into two groups: MSCs group and control group. Besides routine induction therapy (ATG or Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA + prednisone), patients in MSCs group are administered MSCs treatment (1*10^6/kg). Allogeneic bone marrow-derived MSCs (1*10^6/kg) are given intravenously at day 0 (post renal reperfusion during surgery), day 7, day 14 and day 21. The renal allograft function, rejection, patient/graft survival and severe adverse events within 12 months post-transplant are monitored.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Acute Kidney Tubular Necrosis Other: bone marrow-derived mesenchymal stem cells Other: Saline Drug: Induction therapy (ATG or Basiliximab) Drug: Maintenance therapy (Low-dose CNI + MPA + steroids) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Bone Marrow-derived Mesenchymal Stem Cells in Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Multi-center Randomized Controlled Trial
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: MSCs group

Allogeneic bone marrow-derived mesenchymal stem cells (10^6/kg) from third party donors is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21.Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.

The third-party MSCs have no similar HLA alleles of kidney donors, and have no HLA alleles specific to preformed anti-HLA antibodies in recipients prior to KTx.

 Other: bone marrow-derived mesenchymal stem cells
BM-MSCs is harvested from third-party health volunteer donors.
Other Name: BM-MSCs

Drug: Induction therapy (ATG or Basiliximab)
ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group.
Other Name: ATG or Basiliximab

Drug: Maintenance therapy (Low-dose CNI + MPA + steroids)
Maintenance immunosuppressive therapy consists of low-dose tacrolimus and mycophenolic acid and steroids. Recipients receive the same maintenance therapy in both MSCs group and control group.
Other Name: Low-dose tacrolimus + Mycophenolic acid (MPA) + steroids
Placebo Comparator: Control group
Placebo (saline) is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21. Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.
 Other: Saline
Saline as placebo of MSCs

Drug: Induction therapy (ATG or Basiliximab)
ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group.
Other Name: ATG or Basiliximab

Drug: Maintenance therapy (Low-dose CNI + MPA + steroids)
Maintenance immunosuppressive therapy consists of low-dose tacrolimus and mycophenolic acid and steroids. Recipients receive the same maintenance therapy in both MSCs group and control group.
Other Name: Low-dose tacrolimus + Mycophenolic acid (MPA) + steroids


Outcome Measures
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Primary Outcome Measures :
  1. Estimated glomerular filtration rate [ Time Frame: 1 month ]
    eGFR at one month post-transplant


Secondary Outcome Measures :
  1. Incidence of slow graft function [ Time Frame: 12 months ]
  2. Incidence of delayed graft function [ Time Frame: 12 months ]
  3. Proportion of normal renal function recovery [ Time Frame: 12 months ]
  4. Time to renal function recovery [ Time Frame: 12 months ]
  5. Patient survival [ Time Frame: 12 months ]
  6. Renal graft survival [ Time Frame: 12 months ]
  7. Incidence of acute rejection [ Time Frame: 12 months ]
  8. Severe adverse events [ Time Frame: 12 months ]
  9. Estimated glomerular filtration rate [ Time Frame: 12 months ]
    eGFR up to 12 months post-transplant


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Primary kidney transplantation
  2. Receiving induction therapy and combined immunosuppressive regimens (CNIs + MPA + steroids)
  3. Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

Exclusion Criteria:

  1. Secondary kidney transplantation
  2. Combined or multi-organ transplantation
  3. Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
  4. Panel reactive antibody (PRA)>20%
  5. CDC crossmatch is positive
  6. Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
  7. Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
  8. Donors or recipients are known human immunodeficiency virus (HIV) infection
  9. Patients with active infection
  10. Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow-up.
  11. Patients with severe cardiovascular dysfunction
  12. WBC<3*10^9/L or RBC <5g/dL
  13. Highly allergic constitution or having severe history of allergies.
  14. Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption
  15. Patients with a history of cancer within the last 5 years
  16. Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02561767


Contacts
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Contact: Changxi Wang, M.D., Ph.D 86-20-87333428 wangchx@mail.sysu.edu.cn
Contact: Longshan Liu, M.D., Ph.D 86-20-87306082 liulshan@mail.sysu.edu.cn

Locations
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China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Second Affiliated Hospital of Guangzhou Medical University
Investigators
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Study Chair: Changxi Wang, M.D., Ph.D First Affiliated Hospital, Sun Yat-Sen University
More Information
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Additional Information:

Publications:

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Responsible Party: Changxi Wang, Director of Organ Transplant Center, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02561767    
Other Study ID Numbers: MSCs-KTx-DCD-150924
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015
Keywords provided by Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University:
kidney transplantation
mesenchymal stem cell
donation after citizen's death
ischemia reperfusion injury
renal function recovery
Additional relevant MeSH terms:
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Kidney Tubular Necrosis, Acute
Necrosis
Pathologic Processes
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Tacrolimus
Basiliximab
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents