- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02129881
The ONE Study UK Treg Trial (ONETreg1)
The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
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London, United Kingdom, SE1 9RT
- Guy's Hospital
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Oxford, United Kingdom, OX3 7LE
- The Oxford Transplant Centre - Churchill Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Recipient Inclusion Criteria
- 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
- Signed and dated written informed consent
Exclusion Criteria
- Patient has previously received any tissue or organ transplant
- Known contraindication to the protocol-specified treatments / medications
- Genetically identical to the prospective organ donor at the HLA loci (0-0-0 mismatch)
- 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
- EBV-negative; serologically positive for anti-HIV-1,2; HBsAg; Anti-HBc; Anti-HCV-ab; Anti-HTLV-1,2 or syphilis (Treponema palladium)
- 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 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).
Donor Inclusion Criteria
- 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 IM Subproject
- Willing to provide personal and medical/biological data for the trial analysis
- Signed and dated written informed consent. Exclusion Criteria
1. Genetically identical to the prospective organ recipient at the HLA loci (0-0-0 mismatch) 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 designated study personnel 4. Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Autologous regulatory T Cell Product
Autologous regulatory T Cell Product (1-10 million cells/kg) infused intravenously 5 days post renal transplantation. Recipients also receive prednisolone, mycophenolate mofetil, and tacrolimus as detailed below: Prednisolone Day 0: 500 mg IV (250mg pre-op, 250mg intra-op) Day 1: 125 mg IV Day 2 to 14: 20.0 mg/day oral Week 3 to 4: 15.0 mg/day oral Week 5 to 8: 10.0 mg/day oral Week 9 to 12: 5.0 mg/day oral Week 13 to 14: 2.5 mg/day oral Week 15 to End: Cessation Mycophenolate Mofetil (MMF) Day -7 to -2: 500 mg/day oral Day -1 to 14: 2000 mg/day oral Week 3 to 36: 1000 mg/day oral Week 37 to 40: 750 mg/day oral Week 41 to 44: 500 mg/day oral Week 45 to 48: 250 mg/day oral Week 49 to End: Cessation Tacrolimus Day -4 to 14: 3-12 ng/ml oral Week 3 to 12: 3-10 ng/ml oral Week 13 to 36: 3-8 ng/ml oral Week 37 to End: 3-6 ng/ml oral |
Autologous regulatory T Cell Product (1-10 million cells/kg) infused intravenously 5 days post renal transplantation.
Recipients also receive prednisolone, mycophenolate mofetil, and tacrolimus as detailed in the arm description.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of biopsy-confirmed acute rejection.
Time Frame: 60 weeks
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60 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first acute rejection episode
Time Frame: 60 weeks
|
60 weeks
|
Severity of acute rejection episodes
Time Frame: 60 weeks
|
60 weeks
|
Total immunosuppressive burden
Time Frame: 60 weeks
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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 and/or opportunistic infections
Time Frame: 60 weeks
|
60 weeks
|
Incidence of neoplasia.
Time Frame: 60 weeks
|
60 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Giovanna Lombardi, PhD, King's College Hospital NHS Trust
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONETreg1
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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