Reference Group Trial for The ONE Study
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ClinicalTrials.gov Identifier: NCT01656135 |
Recruitment Status
:
Completed
First Posted
: August 2, 2012
Last Update Posted
: March 9, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
End-stage Renal Failure Kidney Graft Rejection | Other: Blood drawing for immune monitoring and questionnaires | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |
Arm | Intervention/treatment |
---|---|
Reference Group
Basiliximab (Simulect®):
Prednisolone:
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:
Tacrolimus (or biologic equivalent):
|
Other: Blood drawing for immune monitoring and questionnaires |
- biopsy-confirmed acute rejection incidence [ Time Frame: 60 weeks ]
- 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 ]
- Immune Monitoring (IM) assessment [ Time Frame: 60 weeks ]
- Health Economics (HEC) assessment [ Time Frame: 60 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
- 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.
Exclusion Criteria:
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).
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
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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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656135
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
France | |
CHU de Nantes Hotel-Dieu | |
Nantes, France, 44093 | |
Germany | |
Charite Campus Virchow-Klinikum | |
Berlin, Germany, 13353 | |
University Hospital Regensburg | |
Regensburg, Germany, 93053 | |
Italy | |
Ospedale San Raffaele | |
Milan, Italy, 20132 | |
United Kingdom | |
Guy's Hospital in affiliation with King's College London | |
London, United Kingdom, SE1 9RT | |
Churchill Hospital in affiliation with the University of Oxford | |
Oxford, United Kingdom, OX3 7LE |
Study Director: | Edward K. Geissler, Ph.D. | University of Regensburg |
Additional Information:
Responsible Party: | Edward Geissler, Chief Investigator and EU Project Leader, University of Regensburg |
ClinicalTrials.gov Identifier: | NCT01656135 History of Changes |
Other Study ID Numbers: |
ONErgt11 260687 ( Other Grant/Funding Number: EU FP7 Programme ) 2011-004301-24 ( EudraCT Number ) |
First Posted: | August 2, 2012 Key Record Dates |
Last Update Posted: | March 9, 2016 |
Last Verified: | March 2016 |
Keywords provided by Edward Geissler, University of Regensburg:
gold standard treatment immune monitoring acute rejection graft rejection |
living-donor renal transplantation kidney transplantation |
Additional relevant MeSH terms:
Renal Insufficiency Kidney Failure, Chronic Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic |