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The ONE Study nTreg Trial (ONEnTreg13) (ONEnTreg13)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02371434
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : February 5, 2020
Information provided by (Responsible Party):
Prof. Dr. Petra Reinke, Charite University, Berlin, Germany

Brief Summary:
The aim of this trial is to collect evidence of the safety of administering autologous CD4+CD25+FoxP3+ natural regulatory T cells (nTregs) to living-donor renal transplant recipients. In addition, the study will determine whether post-transplant nTregs infusion allows a tapering of conventional maintenance immunosuppression within 60 weeks after transplantation.

Condition or disease Intervention/treatment Phase
Immunosuppressive Treatment of Living-donor Renal Transplantation Biological: autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs) Phase 1 Phase 2

Detailed Description:

The ONE Study aims to explore the feasibility, safety and efficacy of regulatory cell therapies as adjunct immunosuppressive treatments in the context of living-donor renal transplantation.The clinical trial presented here (ONEnTreg13) will test autologous, polyclonally expanded CD4+CD25+FoxP3+ nTregs as a somatic cell-based medicinal product.

The objective of this study is to determine whether administration of nTregs to recipients of living-donor kidney transplants is safe and able to polarize the immunological response of the recipient away from graft rejection and towards graft acceptance, allowing a reduction in the doses of pharmacological maintenance immunosuppression.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation - nTregs Trial
Study Start Date : February 2015
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Arm Intervention/treatment
Experimental: Treatment arm

Patients in ONEnTreg13 will be treated with four immunosuppressive agents, all of which are classified as an Investigational Medicinal Products (IMPs):

  • nTregs
  • Prednisolone
  • MMF
  • Tacrolimus
Biological: autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs)
autologous CD4+CD25+FoxP3+ natural regulatory T cells (nTregs). nTregs will be infused at escalating doses of 0.5 x 10^6, 1 x 10^6, and 2.5-3 x 10^6 cells/kg body weight in cohorts of three patients each.

Primary Outcome Measures :
  1. Incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks of organ transplantation [ Time Frame: 60 weeks ]
  2. Incidence of infectious complications associated with cell administration. [ Time Frame: 60 weeks ]
  3. Incidence of embolic pulmonary complications and other embolic events. [ Time Frame: 60 weeks ]
  4. Incidence of immune responses resulting in anaphylactic reactions, cardiovascular compromise or other acute organ failure. [ Time Frame: 60 weeks ]
  5. Biochemical disturbances associated with the cell infusion. [ Time Frame: 60 weeks ]
  6. Over-suppression of the immune system assessed by the incidence of opportunistic infections, especially, CMV, EBV and polyoma virus. [ Time Frame: 60 weeks ]
  7. Over-suppression of the immune system assessed by the incidence of neoplasia. [ Time Frame: 60 weeks ]

Secondary Outcome Measures :
  1. Prevention of acute rejection will be secondarily assessed by measuring [ Time Frame: 60 weeks ]
    i) time to first acute rejection episode ii) severity of acute rejection episodes based on response to treatment and histological scoring iii) the level of total immunosuppression drugs at the final trial visit.

  2. Incidence of patients treated for subclinical acute rejection on the basis of histopathological findings [ Time Frame: 60 weeks ]
  3. Prevention of chronic graft dysfunction (chronic rejection or IF/TA) will be assessed by clinical (impairment of GFR) and histopathological (Banff staging) measures. [ Time Frame: 60 weeks ]
  4. Incidence of post-transplant dialysis, inclusion on the transplant waiting list or retransplantation following graft loss through rejection (acute or chronic). [ Time Frame: 60 weeks ]
  5. Avoidance of drug-related complications by immunosuppressant reduction will be assessed by the incidence of reported adverse drug reactions. [ Time Frame: 60 weeks ]

Information from the National Library of Medicine

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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

Inclusion Criteria for organ recipients:

  • Chronic renal insufficiency with a GFR < 15 ml/min, accepted by the organ transplantation conference, registered by ET (Euro Transplant) and having a positive vote from the living donor ethic commission (Lebendspendekommission) at the Berlin Medical Association.
  • Willing and able to participate in The ONE Study IM and HEC Subprojects.
  • Signed and dated written informed consent. For patients unable to read and/or write, oral informed consent observed by an independent witness is acceptable if the patient has fully understood oral information given by the Investigator. The witness should sign the consent form on behalf of the patient.

Exclusion Criteria for organ recipients:

  • Patient has previously received any tissue or organ transplant other than the planned kidney graft.
  • Known contraindication to protocol-specified treatments / medications.
  • Genetically identical to the prospective organ donor at the HLA loci, the so called "full house match" (0-0-0 mismatch).
  • Panel-Reactive Antibody (PRA) grade > 40% within last 6 months before transplantation.
  • Previous treatment with any desensitization procedure (with or without IVIg).
  • Concomitant malignancy or history of malignancy within 5 years before study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin).
  • Evidence of significant local or systemic infection.
  • CMV-negative recipient receiving a kidney from a CMV-positive donor. EBV-negative recipient receiving a kidney from an EBV-positive donor.
  • HIV-positive or suffering chronic viral hepatitis.
  • Significant liver disease, defined as persistently elevated AST and/or ALT levels > 2 x ULN.
  • Malignant or pre-malignant hematological conditions.
  • Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives.
  • Any condition which, according to the Investigator, would place the subject at undue risk.
  • Ongoing treatment with systemic immunosuppressive drugs at study entry.
  • Participation in another clinical trial during the study or within 28 days prior to planned study entry.
  • Female patients of childbearing potential with a positive pregnancy test at enrolment.
  • Female patients who are breast-feeding.
  • All female patients of childbearing potential unless the patient is willing to maintain a highly effective method of birth control for the duration of the study.
  • Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule.
  • Any form of drug or alcohol abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel.
  • Patients unable to freely give their informed consent (e.g. patients under legal guardianship).
  • Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
  • Known allergy/hypersensitivity to any component of the study product.

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 identifier (NCT number): NCT02371434

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Charité University Medicine, Dept. of Nephrology and Internal Intensive Care
Berlin, Germany, 13353
Sponsors and Collaborators
Prof. Dr. Petra Reinke
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Petra Reinke, Professor of Nephrology, Charite University, Berlin, Germany Identifier: NCT02371434    
Other Study ID Numbers: ONEnTreg13
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020