Insufficient rate of patient recruitment and treatment.
ONEmreg12
The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation - M Reg Trial
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
OTHER_GRANT · European Union FP7 Programme
interventional
8
1 country
1
Study Start
July 24, 2014
Actual (reported)Primary Completion
December 3, 2018
Actual (reported)Study Completion
December 3, 2018
Actual (reported)To collect evidence of the safety of administering donor-derived regulatory macrophage (M reg) preparations to living-donor renal transplant recipients in the context of an international European Union funded consortium aimed at evaluating cellular immunotherapy in solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced by M reg therapy can eventually 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.
December 3, 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.
March 10, 2014
Actual (reported)March 13, 2014
Actual (reported)July 24, 2014
Actual (reported)December 3, 2018
Actual (reported)December 3, 2018
Actual (reported)biopsy-confirmed acute rejection incidence
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
60 weeks
prevention of chronic graft dysfunction (chronic rejection or IF/TA)
60 weeks
incidence of malignancies arising directly from Mreg_UKR
60 weeks
incidence of autoimmune disorders
60 weeks
incidence of inflammatory pathologies
60 weeks
Donor M reg (2.5-7.5 million cells/kg) IV infused (6-7d before Tx) into recipients of a LD renal Tx. Recipients also receive prednisolone, mycophenolate mofetil and tacrolimus, as detailed below: Prednisolone * D 0: 500 mg IV * D 1: 125 mg IV * D 2 - 14: 20.0 mg/d (oral) * Wk 3 - 4: 15.0 mg/d * Wk 5 - 8: 10.0 mg/d * Wk 9 - 12: 5.0 mg/d * Wk 13 - 14: 2.5 mg/d * Wk 15 - 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 - 36: 1000 mg/d * Wk 37 - 40: 750 mg/d * Wk 41 - 44: 500 mg/d * Wk 45 - 48: 250 mg/d * Wk 49 - End: Cessation NOTE: MMF tapering will only happen if a 36-Wk biopsy shows no signs of subclinical rejection or if there is no evidence of declining renal function or if the clinician has any other concern about dose reduction. Tacrolimus (or biologic equiv.) * ≤ 48 h pre-Tx to D 14: 3-12 ng/ml * Wk 3 - 12: 3-10 ng/ml * Wk 13 - 36: 3-8 ng/ml * Wk 37 - End: 3-6 ng/ml
Experimental: M reg treatment Donor M reg (2.5-7.5 million cells/kg) IV infused (6-7d before Tx) into recipients of a living donor renal Tx. 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.
University Hospital Regensburg
Regensburg, 93053, Germany
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.
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.
Edward K Geissler, PhD
University Hospital Regensburg, University of Regensburg
Bernhard Banas, MD
University Hospital Regensburg, University of Regensburg
James A Hutchinson, MD, PhD
University Hospital Regensburg, University of Regensburg
8 participants (actual enrollment reported by the registry).
First Submitted
March 10, 2014
First Posted
March 13, 2014
Study Start
July 24, 2014
Actual (reported)Chinese Medicine on Deferring Dialysis Initiation
Contact the study team to confirm eligibility.
Primary Completion
December 3, 2018
Actual (reported)Study Completion
December 3, 2018
Actual (reported)Last Updated
April 18, 2019
Record last verified: 2019-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: