Renal Failure, End StagePhase 1/2ONEatDCNCT02252055
The ONE Study ATDC Trial
A Phase 1/2 study testing ATDC_Nantes in people with Renal Failure, End Stage, run by Nantes University Hospital at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, End Stage
- What is being tested?
- ATDC_Nantes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2015to 14 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
- Aged at least 18 years
- Able to commence the immunosuppressive regimen at the protocol-specified time point
- Willing and able to participate in The ONE Study IM and HEC subprojects
- Eligible for leucapheresis prior to organ transplantation
- Signed and dated written informed consent
Show all 10Show fewer
- Eligible for live kidney donation
- Willing and able to provide a blood sample for The ONE Study IM Subproject
- Willing to provide personal and medical/biological data for the trial analysis
- Signed and dated written informed consent
Who cannot join
- Patient has previously received any tissue or organ transplant other than the planned kidney graft
- Known contraindication to the protocol-specified treatments / medications (like known allergies to heparin)
- Genetically identical to the prospective organ donor at the HLA loci (A.B.DR 0 mismatch)
- PRA grade > 0 within 6 months prior to enrolment
- Previous treatment with any desensitisation procedure (with or without IVIg)
- Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin)
Show all 36Show fewer
- ABO incompatibility
- Presence of DSA (donor specific antibodies) detected by luminex prior transplantation
- Evidence of significant local or systemic infection
- HIV-positive, EBV-negative or suffering chronic viral hepatitis, syphilis serology- positive
- Significant liver disease, defined as persistently elevated AST and/or ALT levels > 2 x ULN (Upper Limit of Normal range)
- Malignant or pre-malignant haematological conditions
- Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives
- Any condition which, in the judgement of the Investigator, would place the subject at undue risk
- Ongoing treatment with systemic immunosuppressive drugs at inclusion (despite corticoids lower than 10 mg)
- Participation in another clinical trial during the study or within 28 days prior to planned study entry
- Exposure to an investigational product during the study or within 28 days prior to planned study entry
- Female patients of child-bearing potential with a positive pregnancy test at enrolment and F01
- Female patients who are breast-feeding
- All female patients of child-bearing potential* UNLESS:
- The patient is willing to maintain a highly effective method of birth control** for the duration of the study
- The career, lifestyle, or sexual orientation of the patient ensures that there is no risk of pregnancy for the duration of the study (at the discretion of the Investigator)
- Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
- Any form of substance 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. individuals under legal guardianship).
- Criteria specific to the infusion of the ATDCNantes:
- Any pro-coagulant disposition, as evidenced by a past history of thromboembolic disease or abnormal laboratory coagulation parameters which, in the judgement of the Investigator, would place the subject at undue risk
- Any condition resulting in a substantial reduction in the volume of the pulmonary vasculature or an increase in the pulmonary vascular resistance. Any disease or disease process leading to substantially elevated pulmonary arterial pressure (as evidenced by electrocardiography, echocardiography, radiology or cardiac catheterisation) or right heart hypertrophy or dysfunction
- Known atrial or ventricular septal defects posing a risk of paradoxical embolism of infused cells or cell aggregates
- Known hypersensitivity to any component of the cell product or components used in the manufacture of the cell product.
- DONOR
- Genetically identical to the prospective organ recipient at the HLA loci (A.B.DR 0 mismatch)
- Exposure to any investigational agents at the time of kidney donation, or within 28 days prior to kidney donation
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
- Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).
- ABO incompatibility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
Decades of immunosuppressive drug development have produced an array of powerful pharmacological agents, but the various drawbacks associated with these treatments leaves considerable room for improvement. By harnessing the power of suppressive mechanisms in the human immune system, regulatory cell therapy may be able to support peripheral tolerance and induce a level of donor-specific unresponsiveness that allows for a reduction in the use of conventional immunosuppression in organ transplant recipients. Several alternative regulatory cell types have been identified as potential adjunct immunotherapies for solid organ transplantation and are now approaching a stage of development that would allow clinical testing in an early-stage trial. The ONE Study aims to answer the question as whether ATDC treatment, or immunoregulatory cell-based therapy in general, has any place in the clinical management of solid organ transplant recipients.
- Conditions
- Renal Failure, End Stage
- Being tested
- ATDC_Nantes
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATDC_NantesBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| ATDC Treatment | Experimental | 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 Receives: Biological: ATDC_Nantes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy-confirmed acute rejection (BCAR)
Measured: 60 weeks
Secondary outcomes (13)
Time to first acute rejection episode
Measured: 60 weeks
Severity of acute rejection episodes
based on response to treatment and histological scoring
Measured: 60 weeks
Total immunosuppressive burden
assessed at last study visit
Measured: 60 weeks
Incidence of patients treated for subclinical acute rejection on the basis of histopathological findings
Measured: 60 weeks
Prevention of chronic graft dysfunction (chronic rejection or IF/TA)
assessed by clinical (impairment of GFR) and histopathological (Banff staging) measures.
Measured: 60 weeks
Incidence of post-transplant dialysis, inclusion on the transplant waiting list or re-transplantation following graft loss through rejection (acute or chronic).
Measured: 60 weeks
Avoidance of drug-related complications by immunosuppressant reduction
Measured: 60 weeks
Incidence of embolic pulmonary complications and other embolic events
Measured: 60 weeks
Incidence of immunological reactions resulting in anaphylactoid reactions, immediate cardiovascular compromise or other acute organ failure
Measured: 1 week
Biochemical disturbances caused by cell infusion
Measured: 1 week
Over-suppression of the immune system assessed by the incidence of major and/or opportunistic infections, especially CMV, EBV and polyoma virus
Measured: 1 week
Over-suppression of the immune system assessed by the incidence of neoplasia.
Measured: 1 week
Immunological condition of study patients w
an extensive immune monitoring program has been established in the ONE Study
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start19 Mar 2015
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal Failure, End StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward K Geissler, PhD, Study director, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252055
- Sponsor's protocol ID
- RC13_0441
- Acronym
- ONEatDC
- Status last verified
- Dec 2018
- First submitted
- 25 Sep 2014
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23369457Moreau 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.
PubMed 36306921Sawitzki 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.
PubMed 32446407
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02252055
- Acronym / sponsor ID
- ONEatDC / RC13_0441
- Conditions
- Renal Failure, End Stage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 19 Mar 2015 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Decades of immunosuppressive drug development have produced an array of powerful pharmacological agents, but the various drawbacks associated with these treatments leaves considerable room for improvement. By harnessing the power of suppressive mechanisms in the human immune system, regulatory cell therapy may be able to support peripheral tolerance and induce a level of donor-specific unresponsiveness that allows for a reduction in the use of conventional immunosuppression in organ transplant recipients. Several alternative regulatory cell types have been identified as potential adjunct immunotherapies for solid organ transplantation and are now approaching a stage of development that would allow clinical testing in an early-stage trial. The ONE Study aims to answer the question as whether ATDC treatment, or immunoregulatory cell-based therapy in general, has any place in the clinical management of solid organ transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATDC Treatment | Experimental | Biological: ATDC_NantesATDC 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
- Aged at least 18 years
- Able to commence the immunosuppressive regimen at the protocol-specified time point
- Willing and able to participate in The ONE Study IM and HEC subprojects
- Eligible for leucapheresis prior to organ transplantation
Key exclusion criteria (36 listed)
- Patient has previously received any tissue or organ transplant other than the planned kidney graft
- Known contraindication to the protocol-specified treatments / medications (like known allergies to heparin)
- Genetically identical to the prospective organ donor at the HLA loci (A.B.DR 0 mismatch)
- PRA grade > 0 within 6 months prior to enrolment
- Previous treatment with any desensitisation procedure (with or without IVIg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATDC_NantesATDC 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) | Biological | ATDC Treatment |
Primary outcome
Incidence of biopsy-confirmed acute rejection (BCAR)
Time frame: 60 weeks
13 secondary outcomes
Time to first acute rejection episode
Time frame: 60 weeks
Severity of acute rejection episodes
Time frame: 60 weeks
Total immunosuppressive burden
Time frame: 60 weeks
Incidence of patients treated for subclinical acute rejection on the basis of histopathological findings
Time frame: 60 weeks
Prevention of chronic graft dysfunction (chronic rejection or IF/TA)
Time frame: 60 weeks
Incidence of post-transplant dialysis, inclusion on the transplant waiting list or re-transplantation following graft loss through rejection (acute or chronic).
Time frame: 60 weeks
Avoidance of drug-related complications by immunosuppressant reduction
Time frame: 60 weeks
Incidence of embolic pulmonary complications and other embolic events
Time frame: 60 weeks
Incidence of immunological reactions resulting in anaphylactoid reactions, immediate cardiovascular compromise or other acute organ failure
Time frame: 1 week
Biochemical disturbances caused by cell infusion
Time frame: 1 week
Over-suppression of the immune system assessed by the incidence of major and/or opportunistic infections, especially CMV, EBV and polyoma virus
Time frame: 1 week
Over-suppression of the immune system assessed by the incidence of neoplasia.
Time frame: 1 week
Immunological condition of study patients w
Time frame: 60 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Background: PubMed 23369457Geissler 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.
- Derived from this study: PubMed 36306921Moreau 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.
- Derived from this study: PubMed 32446407Sawitzki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward K Geissler, PhD study director
University Hospital Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATDC_Nantes in people with Renal Failure, End Stage, run by Nantes University Hospital at 1 site in France.
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 10 inclusion and 36 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: finished, as of the sponsor's last update on 2 Jan 2019. 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 France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of biopsy-confirmed acute rejection (BCAR) (time frame: 60 weeks). 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 NCT02252055, which also lists 3 linked publications.
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 2 Jan 2019.