End-stage Renal FailurePhase 4NCT01656135
Reference Group Trial for The ONE Study
A Phase 4 study testing Blood drawing for immune monitoring and questionnaires in people with End-stage Renal Failure and Kidney Graft Rejection, run by University of Regensburg at 8 sites in 5 countries.
Trial summary
To investigate the progression of the immunological response in living-donor kidney transplant recipients treated with a standard immunosuppressive regimen. Clinical, immunological, and health-economic data collected during this Reference Group Trial will be used to corroborate historical renal transplantation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Failure, Kidney Graft Rejection
- What is being tested?
- Blood drawing for immune monitoring and questionnaires
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Dec 2012to Dec 2015
- Phase
- Phase 4
- 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
- Organ Donor:
- A prospective donor is eligible for the research if all of the following inclusion criteria apply:
- Eligible for live kidney donation
- Aged at least 18 years
- An ABO blood type compatible with the organ recipient
- Willing and able to provide a blood sample for The ONE Study Subprojects
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- Willing to provide personal and medical/biological data for the trial
- Signed and dated written informed consent.
- In signing the donor information sheet/informed consent form (DIS/ICF), organ donors agree to provide a blood sample for the IM Subproject, and permit access to their medical records for the collection of specified demographic and medical/biological data for the trial.
- Organ Recipient:
- 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 subprojects
- Signed and dated written informed consent.
Who cannot join
- Organ Donor:
- If a prospective donor fulfils any of the following criteria, then they are ineligible for the trial:
- Genetically identical to the prospective organ recipient at the HLA loci
- 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).
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- Organ Recipient:
- Patient has previously received, or is scheduled to receive, any tissue or organ transplant other than the planned kidney graft
- Known sensitivity to tacrolimus, mycophenolate, or corticosteroids
- Genetically identical to the prospective organ donor at the HLA loci
- PRA grade > 40% 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)
- Evidence of significant local or systemic infection
- HIV-positive, EBV-negative or suffering chronic viral hepatitis
- 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 study entry
- Participation in another clinical trial 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
- 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 local 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).
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of California San Francisco
San Francisco, California, 94143
Germany2 sites
Charite Campus Virchow-Klinikum
Berlin, 13353
University Hospital Regensburg
Regensburg, 93053
United Kingdom2 sites
Guy's Hospital in affiliation with King's College London
London, SE1 9RT
Churchill Hospital in affiliation with the University of Oxford
Oxford, OX3 7LE
About this study
Official title: Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
To investigate the progression of the immunological response in living-donor kidney transplant recipients treated with a standard immunosuppressive regimen. Clinical, immunological, and health-economic data collected during this Reference Group Trial will be used to corroborate historical renal transplantation statistics and generate reference ranges for future clinical studies that will test immunoregulatory cell therapy as an adjunct immunosuppressive treatment in renal transplantation.
- Conditions
- End-stage Renal Failure, Kidney Graft Rejection
- Being tested
- Blood drawing for immune monitoring and questionnaires
- Keywords
- gold standard treatment, immune monitoring, acute rejection, graft rejection, living-donor, renal transplantation, kidney transplantation
- 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.
Blood drawing for immune monitoring and questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| Reference Group | Other | Basiliximab (Simulect®):
* Day 0: 20mg IV ≤2h prior to surgery
* Day 4: 20mg IV
Prednisolone:
* Day 0: 500mg IV (250mg pre-op, 250mg intra-op)
* Day 1: 125mg IV
* Day 2 - 14: 20mg/day oral
* Week 3 - 4: 15mg/day oral
* Week 5 - 8: 10mg/day oral
* Week 9 - 12: 5mg/day oral
* Week 13 - 14: 2.5mg/day oral
* Week 15 - Study End: Cessation
Steroid tapering should not proceed if graft rejection has occurred or if renal dysfunction is observed.
Mycophenolate Mofetil (MMF, or biologic equivalent):
Treatment with MMF should commence one day prior to transplantation (on Day -1) and should continue indefinitely, with a dose reduction after two weeks:
* Day -1 - 14: 2g/day oral
* Day 15 - Study End 1.5g/day oral (750mg twice daily)
Tacrolimus (or biologic equivalent):
* Day -4 - 14: 3-12ng/ml
* Week 3 - 12: 3-10ng/ml
* Week 13 - 36: 3-8ng/ml
* Week 37 - Study End: 3-6ng/ml Receives: Other: Blood drawing for immune monitoring and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
biopsy-confirmed acute rejection incidence
Measured: 60 weeks
Secondary outcomes (9)
time to first acute rejection episode
Measured: within 60 weeks
severity of acute rejection episodes
Measured: within 60 weeks
total immunosuppressive burden
Measured: 60 weeks
incidence of chronic graft dysfunction
Measured: 60 weeks
incidence of graft loss through rejection
Measured: 60 weeks
incidence of adverse drug reactions
Measured: 60 weeks
incidence of major infections
Measured: 60 weeks
incidence of neoplasia
Measured: 60 weeks
incidence of patients treated for subclinical acute rejection
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 posted2 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionDec 2015
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 End-stage Renal FailureStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Edward Geissler, University of Regensburg
- Investigators
- Edward K. Geissler, Ph.D., Study director, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656135
- Sponsor's protocol ID
- ONErgt11
- Other IDs
- 260687, 2011-004301-24
- Status last verified
- Mar 2016
- First submitted
- 31 Jul 2012
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sly LM, McKay DM. Macrophage immunotherapy: overcoming impediments to realize promise. Trends Immunol. 2022 Dec;43(12):959-968. doi: 10.1016/j.it.2022.10.002. Epub 2022 Oct 29.
PubMed 36441083Moreau 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 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT01656135
- Acronym / sponsor ID
- ONErgt11
- Conditions
- End-stage Renal Failure, Kidney Graft Rejection
- Keywords
- gold standard treatment, immune monitoring, acute rejection, graft rejection, living-donor, renal transplantation, kidney transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Aug 2012 (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 investigate the progression of the immunological response in living-donor kidney transplant recipients treated with a standard immunosuppressive regimen. Clinical, immunological, and health-economic data collected during this Reference Group Trial will be used to corroborate historical renal transplantation statistics and generate reference ranges for future clinical studies that will test immunoregulatory cell therapy as an adjunct immunosuppressive treatment in renal transplantation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reference Group | Other | Other: Blood drawing for immune monitoring and questionnairesBasiliximab (Simulect®): * Day 0: 20mg IV ≤2h prior to surgery * Day 4: 20mg IV Prednisolone: * Day 0: 500mg IV (250mg pre-op, 250mg intra-op) * Day 1: 125mg IV * Day 2 - 14: 20mg/day oral * Week 3 - 4: 15mg/day oral * Week 5 - 8: 10mg/day oral * Week 9 - 12: 5mg/day oral * Week 13 - 14: 2.5mg/day oral * Week 15 - Study End: Cessation Steroid tapering should not proceed if graft rejection has occurred or if renal dysfunction is observed. Mycophenolate Mofetil (MMF, or biologic equivalent): Treatment with MMF should commence one day prior to transplantation (on Day -1) and should continue indefinitely, with a dose reduction after two weeks: * Day -1 - 14: 2g/day oral * Day 15 - Study End 1.5g/day oral (750mg twice daily) Tacrolimus (or biologic equivalent): * Day -4 - 14: 3-12ng/ml * Week 3 - 12: 3-10ng/ml * Week 13 - 36: 3-8ng/ml * Week 37 - Study End: 3-6ng/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- A prospective donor is eligible for the research if all of the following inclusion criteria apply:
- Eligible for live kidney donation
- Aged at least 18 years
- An ABO blood type compatible with the organ recipient
- Willing and able to provide a blood sample for The ONE Study Subprojects
Key exclusion criteria (29 listed)
- If a prospective donor fulfils any of the following criteria, then they are ineligible for the trial:
- Genetically identical to the prospective organ recipient at the HLA loci
- 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).
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 |
|---|---|---|
| Blood drawing for immune monitoring and questionnaires | Other | Reference Group |
Primary outcome
biopsy-confirmed acute rejection incidence
Time frame: 60 weeks
9 secondary outcomes
time to first acute rejection episode
Time frame: within 60 weeks
severity of acute rejection episodes
Time frame: within 60 weeks
total immunosuppressive burden
Time frame: 60 weeks
incidence of chronic graft dysfunction
Time frame: 60 weeks
incidence of graft loss through rejection
Time frame: 60 weeks
incidence of adverse drug reactions
Time frame: 60 weeks
incidence of major infections
Time frame: 60 weeks
incidence of neoplasia
Time frame: 60 weeks
incidence of patients treated for subclinical acute rejection
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 9 Mar 2016.
- Derived from this study: PubMed 36441083Sly LM, McKay DM. Macrophage immunotherapy: overcoming impediments to realize promise. Trends Immunol. 2022 Dec;43(12):959-968. doi: 10.1016/j.it.2022.10.002. Epub 2022 Oct 29.
- 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, Ph.D. study director
University of Regensburg
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood drawing for immune monitoring and questionnaires in people with End-stage Renal Failure and Kidney Graft Rejection, run by University of Regensburg at 8 sites in 5 countries.
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 15 inclusion and 29 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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany, United Kingdom, France, Italy. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
biopsy-confirmed acute rejection incidence (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 NCT01656135, 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 9 Mar 2016.