Acute Kidney Tubular Necrosis, Kidney Transplantation
Conditions
Keywords
kidney transplantation, mesenchymal stem cell therapy, poor early graft function, delayed graft function, ischemia reperfusion injury, donation after cardiac death
Brief summary
This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) can promote function recovery in patients with poor early graft function after kidney transplantation from Chinese Donation after Citizen Death (DCD). DCD kidney transplant recipients with poor early graft function (with or without dialysis) post transplant are equally randomized into MSCs group or control group. Patients in MSCs group are administered MSCs treatment. Allogeneic BM-MSCs (1\*10\^6/kg) from third party are given intravenously for four consecutive doses every week after enrollment. Patients in control group receive placebo. Renal allograft function (eGFR), rejection, patient/graft survival and severe adverse events up to 12 months post enrollment are monitored.
Interventions
OTHERBM-MSCs
BM-MSCs are from third-party healthy volunteer donors.
OTHERSaline
Saline is the placebo of MSCs in this study.
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
* Primary kidney transplantation * Kidneys are from donation after Chinese citizen death * Poor early graft function with or without dialysis after transplantation * 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
* Secondary kidney transplantation * Combined or multi-organ transplantation * 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 * Panel reactive antibody (PRA)\>20% or CDC crossmatch is positive * Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C * Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B * Donors or recipients are known human immunodeficiency virus (HIV) infection * Patients with active infection * 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. * Patients with severe cardiovascular dysfunction * WBC\<3\*10\^9/L or RBC \<5g/dL * Highly allergic constitution or having severe history of allergies. * Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption * Patients with a history of cancer within the last 5 years * 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 |
|---|---|---|
| Proportion of normal renal function recovery | 12 months | — |
| Time to renal function recovery (days) | 12 months | — |
| Estimated glomerular filtration rate | 12 months | eGFR up to 12 months post transplant |
| patient and graft survival rate | 12 months | patient and graft survival rate up to 12 months post transplantation |
| Incidence of severe adverse events | 12 months | Incidence of severe adverse events up to 12 months post transplantation |
| acute rejection rate | 12 months | Acute rejection rate according to Banff 2013 criteria up to 12 months post transplant |
Countries
China
Contacts
Primary ContactChangxi Wang, M.D., Ph.D
Backup ContactLongshan Liu, M.D., Ph.D
Outcome results
None listed