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Kidney TransplantationPhase 1/2NCT02561767

Effect of BM-MSCs in DCD Kidney Transplantation

A Phase 1/2 study testing bone marrow-derived mesenchymal stem cells, Saline and Induction therapy (ATG or Basiliximab) in people with Kidney Transplantation and Acute Kidney Tubular Necrosis, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
bone marrow-derived mesenchymal stem cells, Saline and Induction therapy (ATG or Basiliximab)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
Oct 2015to Oct 2017
Phase
Phase 1/2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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%
  • CDC crossmatch is positive
  • Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Changxi Wang, M.D., Ph.D contact

86-20-87333428

wangchx@mail.sysu.edu.cn

Longshan Liu, M.D., Ph.D contact

86-20-87306082

liulshan@mail.sysu.edu.cn

China1 site

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

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

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.

Being tested
bone marrow-derived mesenchymal stem cells, Saline, Induction therapy (ATG or Basiliximab), Maintenance therapy (Low-dose CNI + MPA + steroids)
Keywords
kidney transplantation, mesenchymal stem cell, donation after citizen's death, ischemia reperfusion injury, renal function recovery
Medical subject headings
Kidney Tubular Necrosis, Acute, Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bone marrow-derived mesenchymal stem cellsOther

    Also called BM-MSCs

    BM-MSCs is harvested from third-party health volunteer donors.

  • SalineOther

    Saline as placebo of MSCs

  • Induction therapy (ATG or Basiliximab)Drug

    Also called 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.

  • Maintenance therapy (Low-dose CNI + MPA + steroids)Drug

    Also called Low-dose tacrolimus + Mycophenolic acid (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.

Study groups in NCT02561767
Study groupRoleWhat they receive
MSCs groupExperimentalAllogeneic 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.
Receives: Other: bone marrow-derived mesenchymal stem cells; Drug: Induction therapy (ATG or Basiliximab); Drug: Maintenance therapy (Low-dose CNI + MPA + steroids)
Control groupPlacebo comparatorPlacebo (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.
Receives: Other: Saline; Drug: Induction therapy (ATG or Basiliximab); Drug: Maintenance therapy (Low-dose CNI + MPA + steroids)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimated glomerular filtration rate

    eGFR at one month post-transplant

    Measured: 1 month

Secondary outcomes (9)

  1. Incidence of slow graft function

    Measured: 12 months

  2. Incidence of delayed graft function

    Measured: 12 months

  3. Proportion of normal renal function recovery

    Measured: 12 months

  4. Time to renal function recovery

    Measured: 12 months

  5. Patient survival

    Measured: 12 months

  6. Renal graft survival

    Measured: 12 months

  7. Incidence of acute rejection

    Measured: 12 months

  8. Severe adverse events

    Measured: 12 months

  9. Estimated glomerular filtration rate

    eGFR up to 12 months post-transplant

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2016 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02561767
Sponsor's protocol ID
MSCs-KTx-DCD-150924
Status last verified
Sep 2015
First submitted
25 Sep 2015
Last updated
28 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • Peng Y, Ke M, Xu L, Liu L, Chen X, Xia W, Li X, Chen Z, Ma J, Liao D, Li G, Fang J, Pan G, Xiang AP. Donor-derived mesenchymal stem cells combined with low-dose tacrolimus prevent acute rejection after renal transplantation: a clinical pilot study. Transplantation. 2013 Jan 15;95(1):161-8. doi: 10.1097/TP.0b013e3182754c53.

    PubMed 23263506

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bone marrow-derived mesenchymal stem cells, Saline and Induction therapy (ATG or Basiliximab) in people with Kidney Transplantation and Acute Kidney Tubular Necrosis, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

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 16 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 28 Sep 2015. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Changxi Wang, M.D., Ph.D (86-20-87333428, wangchx@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated glomerular filtration rate (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02561767, which also lists 1 linked publication.

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 28 Sep 2015.

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