Acute Kidney Tubular Necrosis, Kidney Transplantation
Conditions
Keywords
kidney transplantation, mesenchymal stem cell, donation after citizen's death, ischemia reperfusion injury, renal function recovery
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.
Interventions
BM-MSCs is harvested from third-party health volunteer donors.
OTHERSaline
Saline as placebo of MSCs
DRUGInduction 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.
DRUGMaintenance 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.
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated glomerular filtration rate | 1 month | eGFR at one month post-transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delayed graft function | 12 months | — |
| Proportion of normal renal function recovery | 12 months | — |
| Time to renal function recovery | 12 months | — |
| Patient survival | 12 months | — |
| Incidence of slow graft function | 12 months | — |
| Incidence of acute rejection | 12 months | — |
| Severe adverse events | 12 months | — |
| Estimated glomerular filtration rate | 12 months | eGFR up to 12 months post-transplant |
| Renal graft survival | 12 months | — |
Countries
China
Contacts
Primary ContactChangxi Wang, M.D., Ph.D
Backup ContactLongshan Liu, M.D., Ph.D
Outcome results
None listed