Reference Group Trial for The ONE Study

March 8, 2016 updated by: Edward Geissler, University of Regensburg

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • CHU de Nantes Hôtel-Dieu
  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum
      • Regensburg, Germany, 93053
        • University Hospital Regensburg
  • Italy
      • Milan, Italy, 20132
        • Ospedale San Raffaele
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital in affiliation with King's College London
      • Oxford, United Kingdom, OX3 7LE
        • Churchill Hospital in affiliation with the University of Oxford
  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Organ Donor:

A prospective donor is eligible for the research if all of the following inclusion criteria apply:

  1. Eligible for live kidney donation
  2. Aged at least 18 years
  3. An ABO blood type compatible with the organ recipient
  4. Willing and able to provide a blood sample for The ONE Study Subprojects
  5. Willing to provide personal and medical/biological data for the trial
  6. 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:

  1. Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
  2. Aged at least 18 years
  3. Able to commence the immunosuppressive regimen at the protocol-specified time point
  4. Willing and able to participate in The ONE Study subprojects
  5. 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:

  1. Genetically identical to the prospective organ recipient at the HLA loci
  2. Exposure to any investigational agents at the time of kidney donation, or within 28 days prior to kidney donation
  3. 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
  4. Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).

Organ Recipient:

  1. Patient has previously received, or is scheduled to receive, any tissue or organ transplant other than the planned kidney graft
  2. Known sensitivity to tacrolimus, mycophenolate, or corticosteroids
  3. Genetically identical to the prospective organ donor at the HLA loci
  4. PRA grade > 40% within 6 months prior to enrolment
  5. Previous treatment with any desensitisation procedure (with or without IVIg)
  6. 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)
  7. Evidence of significant local or systemic infection
  8. HIV-positive, EBV-negative or suffering chronic viral hepatitis
  9. Significant liver disease, defined as persistently elevated AST and/or ALT levels >2 x ULN (Upper Limit of Normal range)
  10. Malignant or pre-malignant haematological conditions
  11. Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives
  12. Any condition which, in the judgement of the Investigator, would place the subject at undue risk
  13. Ongoing treatment with systemic immunosuppressive drugs at study entry
  14. Participation in another clinical trial during the study or within 28 days prior to planned study entry
  15. Female patients of child-bearing potential with a positive pregnancy test at enrolment
  16. Female patients who are breast-feeding

  17. All female patients of child-bearing potential UNLESS:

    1. The patient is willing to maintain a highly effective method of birth control for the duration of the study
    2. 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)
  18. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
  19. 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
  20. Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Reference Group

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
Other: Blood drawing for immune monitoring and questionnaires

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
biopsy-confirmed acute rejection incidence
Time Frame: 60 weeks
60 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
incidence of patients treated for subclinical acute rejection
Time Frame: 60 weeks
60 weeks
time to first acute rejection episode
Time Frame: within 60 weeks
within 60 weeks
severity of acute rejection episodes
Time Frame: within 60 weeks
within 60 weeks
total immunosuppressive burden
Time Frame: 60 weeks
60 weeks
incidence of chronic graft dysfunction
Time Frame: 60 weeks
60 weeks
incidence of graft loss through rejection
Time Frame: 60 weeks
60 weeks
incidence of adverse drug reactions
Time Frame: 60 weeks
60 weeks
incidence of major infections
Time Frame: 60 weeks
60 weeks
incidence of neoplasia
Time Frame: 60 weeks
60 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Immune Monitoring (IM) assessment
Time Frame: 60 weeks
60 weeks
Health Economics (HEC) assessment
Time Frame: 60 weeks
60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Regensburg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Edward K. Geissler, Ph.D., University of Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONErgt11
  • 260687 (Other Grant/Funding Number: EU FP7 Programme)
  • 2011-004301-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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