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CompletedNCT02371434ONEnTreg13Updated Feb 5, 2020

The ONE Study nTreg Trial (ONEnTreg13)

A Phase 1/2 interventional study of autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs) in Immunosuppressive Treatment of Living-donor Renal Transplantation, sponsored by Prof. Dr. Petra Reinke. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Prof. Dr. Petra Reinke · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Immunosuppressive Treatment of Living-donor Renal Transplantation
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In context

Lead sponsor

Prof. Dr. Petra Reinke is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • 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)

Interventions

  • Biologicalautologous 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.

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What researchers measure

Primary outcomes

  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 outcomes

  1. Prevention of acute rejection will be secondarily assessed by measuring

    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.

    Time frame: 60 weeks

  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

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Study locations

1 site
  • Charité University Medicine, Dept. of Nephrology and Internal Intensive Care
    Berlin, 13353, Germany
08

References and documents

Publications

  • Roemhild A, Otto NM, Moll G, Abou-El-Enein M, Kaiser D, Bold G, Schachtner T, Choi M, Oellinger R, Landwehr-Kenzel S, Juerchott K, Sawitzki B, Giesler C, Sefrin A, Beier C, Wagner DL, Schlickeiser S, Streitz M, Schmueck-Henneresse M, Amini L, Stervbo U, Babel N, Volk HD, Reinke P. Regulatory T cells for minimising immune suppression in kidney transplantation: phase I/IIa clinical trial. BMJ. 2020 Oct 21;371:m3734. doi: 10.1136/bmj.m3734. PubMed 33087345 ↗
  • Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Boger CA, Scotta C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Ollinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyo J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7. Erratum In: Lancet. 2020 Jun 27;395(10242):1972. doi: 10.1016/S0140-6736(20)31419-7. PubMed 32446407 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02371434
Lead sponsor
Prof. Dr. Petra Reinke
Responsible party
Prof. Dr. Petra Reinke (Professor of Nephrology, Charite University, Berlin, Germany) — Sponsor-investigator
First posted
Feb 25, 2015
Start date
Feb 2015
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017
Last update
Feb 5, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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