ONEatDC
A Phase I/II Monocentric Trial of Cellular Immunotherapy Based on Autologous Tolerogenic Dendritic Cells (ATDCs) Administration in Patients With Renal Insufficiency Receiving as First Transplantation a Kidney Transplant From a Living-donor.
Sponsor study identifier
interventional
11
1 country
1
Study Start
March 19, 2015
Actual (reported)Primary Completion
November 14, 2018
Actual (reported)Study Completion
November 14, 2018
Actual (reported)To collect evidence of the safety of administering autologous tolerogenic dendritic cells (ATDC) preparations to living-donor renal transplant recipients in the context of an international European Union funded consortium aimed at evaluationg cellular immunotherapy in solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced by ATDC therapy can evntually be used to reduce the need for conventional immunosuppression in transplant recipients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 14, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 25, 2014
Actual (reported)September 29, 2014
Actual (reported)March 19, 2015
Actual (reported)November 14, 2018
Actual (reported)November 14, 2018
Actual (reported)Incidence of biopsy-confirmed acute rejection (BCAR)
60 weeks
Time to first acute rejection episode
60 weeks
Severity of acute rejection episodes
60 weeks
Total immunosuppressive burden
60 weeks
Incidence of patients treated for subclinical acute rejection on the basis of histopathological findings
60 weeks
Prevention of chronic graft dysfunction (chronic rejection or IF/TA)
60 weeks
Incidence of malignancies arising directly from ATDC_Nantes
60 weeks
ii) incidence of autoimmune disorders
60 weeks
Incidence of inflammatory pathologies
60 weeks
ATDC treatment (1 x 106 cells/kg BW slow peripheral venous) occurs the day before transplantation. Recipients also receive prednisolone, Mycophenolate Mofetil and tacrolimus, as detailed below : Prednidolone : * D 0: 500 mg IV * D 1: 125 mg IV * D 2 to 14: 20.0 mg/d * Wk 3 to 4: 15.0 mg/d * Wk 5 to 8: 10.0 mg/d * Wk 9 to 12: 5.0 mg/d * Wk 13 to 14: 2.5 mg/d * Wk 15 to End:Cessation MMF (or biologic equiv.): * D -7 to -2: 500 mg/d (250mg 2x/d) * D -1 to 14: 2000 mg/d * Wk 3 to 36: 1000 mg/d * Wk 37 to 40: 750 mg/d * Wk 41 to 44: 500 mg/d * Wk 45 to 48: 250 mg/d * Wk 49 to End:Cessation Note : MMF tapering will only happen if the 36-week protocol biopsy shows no signs of subclinical rejection and there is evidence of declining renal function or if the clinician has any other concern about MMF dose reduction. Tacrolimus : * ≤ 48 h pre-Tx to D 14: 3-12 ng/ml * Wk 3 to 12: 3-10 ng/ml * Wk 13 to 36: 3-8 ng/ml * Wk 37 to End: 3-6 ng/ml
ATDC treatment (1 x 106 cells/kg BW slow peripheral venous) occurs the day before transplantation into recipients also recipients of a living donor renal transplantation. Recipients also receive prednisolone, Mycophenolate Mofetil and tacrolimus background immunosuppression ( as described in detail in the arm description)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Nantes University hospital
Nantes, 44093, France
Geissler EK. The ONE Study compares cell therapy products in organ transplantation: introduction to a review series on suppressive monocyte-derived cells. Transplant Res. 2012 Sep 28;1(1):11. doi: 10.1186/2047-1440-1-11. No abstract available.
Moreau A, Kervella D, Bouchet-Delbos L, Braudeau C, Saiagh S, Guerif P, Limou S, Moreau A, Bercegeay S, Streitz M, Sawitzki B, James B, Harden PN, Game D, Tang Q, Markmann JF, Roberts ISD, Geissler EK, Dreno B, Josien R, Cuturi MC, Blancho G; DIVAT consortium. A Phase I/IIa study of autologous tolerogenic dendritic cells immunotherapy in kidney transplant recipients. Kidney Int. 2023 Mar;103(3):627-637. doi: 10.1016/j.kint.2022.08.037. Epub 2022 Oct 26.
Edward K Geissler, PhD
University Hospital Regensburg
11 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2014
First Posted
September 29, 2014
Study Start
March 19, 2015
Actual (reported)Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation
Contact the study team to confirm eligibility.
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.
Primary Completion
November 14, 2018
Actual (reported)Study Completion
November 14, 2018
Actual (reported)Last Updated
January 2, 2019
Record last verified: 2018-12
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Source: ClinicalTrials.gov.
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