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Trial record 1 of 1 for:    ctot-21
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Treg Therapy in Subclinical Inflammation in Kidney Transplantation (TASK)

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ClinicalTrials.gov Identifier: NCT02711826
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE March 11, 2016
First Posted Date  ICMJE March 17, 2016
Last Update Posted Date May 20, 2020
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • Timing of Banff 2A or higher acute cell-mediated rejection and/or acute antibody mediated rejection [ Time Frame: Baseline (Day 0) to Day 405 ]
    The safety of polyTregs will be described in comparison with CNI-based maintenance IS therapy.
  • Incidence of Banff 2A or higher acute cell-mediated rejection and/or acute antibody mediated rejection [ Time Frame: Baseline (Day 0) to Day 405 ]
    The safety of polyTregs will be described in comparison with CNI-based maintenance IS therapy.
  • Timing of study defined Grade 3 or higher infection [ Time Frame: Baseline (Day 0) to Day 405 ]
    The safety of polyTregs will be described in comparison with CNI-based maintenance IS therapy.
  • Incidence of study defined Grade 3 or higher infection [ Time Frame: Baseline (Day 0) to Day 405 ]
    The safety of polyTregs will be described in comparison with CNI-based maintenance IS therapy.
  • Percent change in inflammation [ Time Frame: Baseline and 7 months after study group allocation ]
    As measured by the percentage area of cortex occupied by inflammatory cells using computer-assisted quantitative image analysis on the biopsy, expressed as the percent change relative to the baseline biopsy.
  • Immunologic profiles of kidney transplant recipients [ Time Frame: At 2 weeks after infusion (PolyTregs group) and 7 months after group allocation ]
    Immunologic profiles using the common response module (CRM) graft gene expression of rejection and/or histologic evidence of inflammation in biopsies.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2016)
  • Timing of Banff 2A or higher acute cell-mediated rejection and/or acute antibody mediated rejection [ Time Frame: Baseline (Day 0) to Day 405 ]
    The safety of polyTregs and/or darTregs will be described in comparison with CNI-based maintenance IS therapy.
  • Incidence of Banff 2A or higher acute cell-mediated rejection and/or acute antibody mediated rejection [ Time Frame: Baseline (Day 0) to Day 405 ]
    The safety of polyTregs and/or darTregs will be described in comparison with CNI-based maintenance IS therapy.
  • Timing of study defined Grade 3 or higher infection [ Time Frame: Baseline (Day 0) to Day 405 ]
    The safety of polyTregs and/or darTregs will be described in comparison with CNI-based maintenance IS therapy.
  • Incidence of study defined Grade 3 or higher infection [ Time Frame: Baseline (Day 0) to Day 405 ]
    The safety of polyTregs and/or darTregs will be described in comparison with CNI-based maintenance IS therapy.
  • Percent change in inflammation [ Time Frame: Baseline (pre-randomization) and 7 months after randomization. ]
    As measured by the percentage area of cortex occupied by inflammatory cells using computer-assisted quantitative image analysis on the biopsy, expressed as the percent change relative to the baseline (pre-randomization) biopsy.
  • Immunologic profiles of kidney transplant recipients [ Time Frame: At 2 weeks after infusion (PolyTregs and darTregs groups) and 7 months after randomization (all groups). ]
    Immunologic profiles using the common response module (CRM) graft gene expression of rejection and/or histologic evidence of inflammation in biopsies.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • Timing of polyTregs infusion reactions [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs.
  • Incidence of polyTregs infusion reactions [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs.
  • Severity of polyTregs infusion reactions [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs.
  • Timing of culture-proven and clinically diagnosed infection [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs.
  • Incidence of culture-proven and clinically diagnosed infection. [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs.
  • Severity of culture-proven and clinically diagnosed infection [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs.
  • Timing of acute rejection using Banff grading [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs. Banff 2007 Type 1A or higher and clinical treatment for acute rejection. Central reading will be utilized when accounting for study stopping rule and for safety endpoint.
  • Incidence of acute rejection using Banff grading [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs. Banff 2007 Type 1A or higher and clinical treatment for acute rejection. Central reading will be utilized when accounting for study stopping rule and for safety endpoint.
  • Severity of acute rejection using Banff grading [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs. Banff 2007 Type 2A or higher and clinical treatment for acute rejection. Central reading will be utilized when accounting for study stopping rule and for safety endpoint.
  • Timing of BK viremia and cytomegalovirus (CMV) reactivation [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs.
  • Incidence of BK viremia and CMV reactivation [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs.
  • Timing of > 10% decrease in estimated Glomerular Filtration Rate (eGFR ) compared to baseline [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs .
  • Incidence of > 10% decrease in eGFR compared to baseline [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs.
  • Timing of acute rejection in PolyTregs group [ Time Frame: Day 69 to Day 405 ]
    To assess safety of mTOR therapy after Treg infusion. Subjects who receive Tregs in either group who convert to mTOR therapy will be compared to subjects who did not convert to mTOR therapy; as well as subjects in CNI Maintenance group.
  • Incidence of acute rejection in PolyTregs group [ Time Frame: Day 69 to Day 405 ]
    To assess safety of mTOR therapy after Treg infusion. Subjects who receive Tregs in either group who convert to mTOR therapy will be compared to subjects who did not convert to mTOR therapy; as well as subjects in CNI Maintenance group.
  • Proportion of subjects exhibiting a relative decrease of 25% or more inflammation on kidney biopsy [ Time Frame: Baseline to 2 weeks after polyTregs ]
    Measured as the percentage area of cortex occupied by inflammatory cells using computer-assisted quantitative image analysis on the baseline kidney biopsy and the biopsy 2 weeks after polyTregs.
  • Proportion of subjects who exhibit a relative decrease of 50% or more inflammation on kidney biopsy [ Time Frame: Baseline to 2 weeks after polyTregs ]
  • Proportion of subjects who exhibit a relative decrease of 25% or more inflammation on kidney biopsy [ Time Frame: Baseline to 7 months after group allocation ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2016)
  • Timing of polyTregs and/or darTreg infusion reactions [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups
  • Incidence of polyTregs and/or darTreg infusion reactions [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups
  • Severity of polyTregs and/or darTreg infusion reactions [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups
  • Timing of culture-proven and clinically diagnosed infection [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups
  • Incidence of culture-proven and clinically diagnosed infection. [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups
  • Severity of culture-proven and clinically diagnosed infection [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups
  • Timing of acute rejection using Banff grading [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups Banff 2007 Type 1A or higher and clinical treatment for acute rejection. Central reading will be utilized when accounting for study stopping rule and for safety endpoint.
  • Incidence of acute rejection using Banff grading [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups. Banff 2007 Type 1A or higher and clinical treatment for acute rejection. Central reading will be utilized when accounting for study stopping rule and for safety endpoint.
  • Severity of acute rejection using Banff grading [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups Banff 2007 Type 2A or higher and clinical treatment for acute rejection. Central reading will be utilized when accounting for study stopping rule and for safety endpoint.
  • Timing of BK viremia and cytomegalovirus (CMV) reactivation [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups
  • Incidence of BK viremia and CMV reactivation [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups
  • Timing of > 10% decrease in eGFR compared to baseline [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups
  • Incidence of > 10% decrease in eGFR compared to baseline [ Time Frame: Baseline (Day 0) to Day 405 ]
    To assess safety of PolyTregs and darTregs in all groups
  • Timing of acute rejection in PolyTregs and darTregs groups [ Time Frame: Day 69 to Day 405 ]
    To assess safety of mTOR therapy after Treg infusion. Subjects who receive Tregs in either group who convert to mTOR therapy will be compared to subjects who did not convert to mTOR therapy; as well as subjects in CNI Maintenance group.
  • Incidence of acute rejection in PolyTregs and darTregs groups [ Time Frame: Day 69 to Day 405 ]
    To assess safety of mTOR therapy after Treg infusion. Subjects who receive Tregs in either group who convert to mTOR therapy will be compared to subjects who did not convert to mTOR therapy; as well as subjects in CNI Maintenance group.
  • Proportion of subjects exhibiting a relative decrease of 25% or more inflammation on kidney biopsy [ Time Frame: Baseline (pre-randomization) to 2 weeks after polyTregs and/or darTregs ]
    Measured as the percentage area of cortex occupied by inflammatory cells using computer-assisted quantitative image analysis on the baseline (pre-randomization) kidney biopsy and the biopsy 2 weeks after polyTregs and/or darTregs.
  • Proportion of subjects who exhibit a relative decrease of 50% or more inflammation on kidney biopsy [ Time Frame: Baseline (pre-randomization) to 2 weeks after polyTregs and/or darTregs ]
  • Proportion of subjects who exhibit a relative decrease of 25% or more inflammation on kidney biopsy [ Time Frame: Baseline (pre-randomization) to 7 months after randomization. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treg Therapy in Subclinical Inflammation in Kidney Transplantation
Official Title  ICMJE Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation (CTOT-21)
Brief Summary

The purpose of this study is:

  • To see if polyTregs can reduce inflammation in a transplanted kidney.
  • To find out what effects, good or bad, polyTregs will have in the kidney recipient.
  • To find out what effects, good or bad, taking everolimus after polyTregs will have in the kidney recipient.
Detailed Description

Inflammation occurs when the body's defense system recognizes a foreign object (such as a transplanted kidney), and responds by sending white blood cells to attack the foreign object. These cells and the substances they produce can damage the transplanted kidney. There is currently no standard treatment for inflammation in the kidney; some transplant centers do not treat inflammation at all. Rejection is a more severe form of inflammation and injury. Both inflammation and rejection are diagnosed by looking at a piece of kidney (a kidney biopsy) under a microscope. Kidneys that have inflammation and/or rejection do not work as well or last as long as kidneys without injury.

People who have a transplant take immunosuppressive drugs (IS) to prevent inflammation and rejection. Although kidney transplant recipients usually do well in the first five years after transplant, transplant researchers are interested in finding ways to prevent inflammation and rejection without IS, or with lower doses of IS in order to avoid side effects.

While some white blood cells cause inflammation, other types of white blood cells, called T regulatory cells (Tregs), can control inflammation. Tregs may have an important role in controlling or preventing inflammation and rejection. A person's Tregs can be grown in the laboratory to increase their number (polyTreg). These Tregs can be given back through a needle placed in a vein (IV). PolyTregs, when given to the recipient, might reduce inflammation in the transplanted kidney. However, this effect has not yet been shown.

One of the IS drugs used in kidney transplant is Everolimus. Everolimus has been shown to help Tregs survive better than other types of IS drugs.

This is a randomized open‐label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with subclinical inflammation (SCI) in the 3 to 7 months post‐transplant allograft protocol biopsy compared to control patients treated with CNI‐based immunosuppression. The efficacy of the Treg therapy will be assessed by the reduction of graft inflammation on biopsies performed at 7 months after study group allocation compared to the eligibility biopsy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Transplant
  • Adult Living Donor Kidney Transplant Recipients
  • Renal Transplant
  • Living Kidney Donor
Intervention  ICMJE
  • Biological: Polyclonal Regulatory T Cells
    Participants randomized to polyTregs group will receive a single infusion of 550 ± 450 x 10^6 polyTregs.
    Other Names:
    • Polyclonal Tregs
    • polyTregs
  • Drug: Everolimus
    Other Name: Zortress
  • Drug: Tacrolimus
    Other Names:
    • FK-506
    • FR-900506
    • Prograf
  • Drug: Mycophenolate mofetil
    All enrolled participants will be on MMF (or MPA below) at the time of study entry at a minimum dose of 1000mg per day.
    Other Names:
    • Cellcept
    • MMF
  • Drug: Mycophenolic acid
    All enrolled participants will be on MPA (or MMF above) at the time of study entry at a minimum dose of 720mg per day.
    Other Names:
    • Myfortic
    • MPA
  • Drug: Acetaminophen
    650 mg acetaminophen, administered 30-60 minutes prior to infusion as pre-medication.
    Other Name: Tylenol
  • Drug: Diphenhydramine
    25-50 mg diphenhydramine intravenously or by mouth, administered 30-60 minutes prior to infusion as pre-medication.
    Other Name: Benadryl
  • Procedure: Biopsy, Kidney
    Other Name: Kidney Biopsy
  • Procedure: Blood Draw
    Other Names:
    • Phlebotomy
    • Venipuncture
  • Procedure: Leukapheresis
    Other Name: leukocytapheresis
  • Procedure: IS regimen conversion
    Conversion from Tacrolimus, a calcineurin inhibitors (CNI), to Everolimus, an mTOR inhibitor.
    Other Name: Everolimus Conversion
Study Arms  ICMJE
  • Active Comparator: Maintenance CNI based immunosuppression therapy group

    Standard of care

    (N=15 participants in this group)

    Interventions:
    • Drug: Tacrolimus
    • Drug: Mycophenolate mofetil
    • Drug: Mycophenolic acid
    • Procedure: Biopsy, Kidney
    • Procedure: Blood Draw
  • Experimental: Polyclonal Regulatory T Cells group

    Subjects to receive polyTregs (550 ± 450 x 10^6). After receiving at least 300X10^6 polyTregs infusion, eligible subjects will start mammalian Target of Rapamycin (mTOR) inhibitor.

    Target tacrolimus trough levels prior to conversion to everolimus are 4-11 μg/dl, which falls within standard of care. For eligible participants in polyTregs and darTregs groups, the tacrolimus dose will be reduced by 50% when everolimus is initiated. Tacrolimus will be discontinued 4 weeks after initiation of everolimus therapy.

    Everolimus, a mTOR inhibitor immunosuppressant, will be initiated at a dose of 1.5 mg orally twice daily and titrated, as needed. Participants will begin everolimus with target trough levels of 3-8μg/L for 4 weeks while still taking tacrolimus. Everolimus target trough levels will be 6-10 μg/L when tacrolimus is discontinued.

    (N=15 participants in this group)

    Interventions:
    • Biological: Polyclonal Regulatory T Cells
    • Drug: Everolimus
    • Drug: Tacrolimus
    • Drug: Mycophenolate mofetil
    • Drug: Mycophenolic acid
    • Drug: Acetaminophen
    • Drug: Diphenhydramine
    • Procedure: Biopsy, Kidney
    • Procedure: Blood Draw
    • Procedure: Leukapheresis
    • Procedure: IS regimen conversion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2016)
45
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study participants:

  1. Subject must be able to understand and provide informed consent;
  2. Age ≥18 years of age at the time of study entry;
  3. Recipients of non- Human Leukocyte Antigen (HLA) identical living or deceased renal transplants;
  4. Protocol renal allograft biopsy at 5 months (± 8 weeks) after transplantation with Banff i1 and/or ti1 with concomitant t scores t0, t1,t2 or t3; Banff i2 and/or ti2 with concomitant t scores t0 or t1; and without v > 0, [ptc + g] ≥2, C4d >1 (by immunofluorescence, IF), or C4d > 0 (by immunohistochemistry, IHC); confirmed by central pathologist. Subjects must not be treated for pathologic criteria (e.g. steroids).
  5. Estimated glomerular filtration rate (eGFR) ≥30 ml/min at the time of study entry;
  6. Maintenance immunosuppression consisting of tacrolimus, MMF/MPA (≥1000 mg/720 mg daily) ± prednisone (≤10 mg/day);
  7. Current immunizations including TdAP, hepatitis B, pneumococcal and seasonal influenza vaccines at the time of study entry, completed prior to enrollment and no less than 14 days prior to planned manufacturing collection;
  8. Documented Hepatitis B (HB) serologies must be:

    1. Positive HB surface antibody, negative HB core antibody and negative HB surface antigen for recipients immune to hepatitis B
    2. Negative HB surface antibody, negative HB core antibody and negative HB surface antigen for non-immune/ HBV naïve recipients provided donor had negative HB core antibody and negative HB surface antigen at the time of donation.
  9. Hepatitis C Virus Ab positive subjects with negative HCV PCR are eligible if they have spontaneously cleared infection or are in sustained virologic remission for at least 12 weeks after treatment for hepatitis C infection;
  10. Negative TB test (PPD, interferon-gamma release assay, ELISPOT testing) within 1 year prior to enrollment. Subjects with a history of TB (positive TB test without active infection) must have completed one of the latent TB infection treatment regimens endorsed by the CDC (Division of TB Elimination, 2016). Alternative regimens for latent TB infection eradication will be adjudicated by the site's infectious disease specialist.
  11. Female subjects of childbearing potential must have reviewed the Mycophenolate Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) and have a negative pregnancy test upon study entry (Reference:https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm318880.htm); and
  12. Female subjects with child-bearing potential, must agree to use FDA approved methods of birth control for the duration of the study; subjects must consult with their physician and determine the most suitable method(s) that are greater than 80% effective (http://www.fda.gov/birthcontrol).

Treg Infusion Inclusion Criteria:

  1. Individuals randomized to the polyTreg and darTreg groups who continue to meet all of the enrollment criteria; and
  2. Negative SARS-COV2 by RTP-PCR testing within 1 week of Treg infusion.

mTOR Conversion Inclusion Criteria:

Individuals who meet all of these criteria are eligible for mTOR conversion:

  1. Received either polyTreg or darTregs infusion; and
  2. Inflammatory load on 2 week post-infusion biopsy has decreased by ≥50% relative to the baseline biopsy, confirmed by central pathologist.

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study participants:

  1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
  2. History of malignancy; except adequately treated basal cell carcinoma;
  3. History of graft loss from acute rejection within 1 year after any previous transplant;
  4. History of transplant renal artery stenosis;
  5. History of cellular rejection prior to enrollment that did not respond to steroids and/or subsequent creatinine after treatment for rejection greater than 15% above baseline;
  6. Known hypersensitivity to mTOR inhibitors or contraindication to everolimus (including history of wound healing complications);
  7. Any chronic illness requiring uninterrupted anti-coagulation after kidney transplantation;
  8. Post-transplant DSA >5000 MFI or post-transplant treatment with IVIg for DSA.

    • Note: Enrolled subjects with post-transplant DSA >2000 MFI will not be eligible for mTOR conversion.
  9. Positive HIV 1 or HIV 2 serology prior to transplantation;
  10. Positive HBSAg or HBcAb serology;
  11. Proteinuria with urine protein-to-creatinine ratio > 1.0 g/g;
  12. Any condition requiring chronic use of corticosteroids >10mg/day at the time of study entry;
  13. Subjects requiring treatment for pathologic findings on study eligibility biopsy (see inclusion 5).
  14. Active infection at the time of study entry;
  15. History of active TB or latent TB without adequate treatment;
  16. Serum BK virus >1,000 copies/ml by Polymerase Chain Reaction (PCR) at the time of study entry;
  17. Hematocrit <27%; Absolute Neutrophil Count (ANC) < 1,000/μL; and/or lymphocyte count <500/μL at the time of study entry;
  18. Participation in any other studies with investigational drugs or regimens in the preceding year;
  19. Any condition or prior treatment which, in the opinion of the investigator, precludes study participation.
  20. Unable to provide adequate biopsy specimen (paraffin embedded formalin fixed) from eligibility biopsy (3-7 months post -transplant) for quantitative analysis.
  21. Epstein-Barr virus (EBV) naïve recipient of a kidney from an EBV positive donor; and/or historically EBV naïve recipient with primary EBV infection at the time of screening (e.g., anti-VCA IgM positive and EBNA negative), a positive EBV PCR.

Treg Infusion Exclusion Criteria:

Individuals randomized to polyTreg and darTreg groups who meet any of these criteria are not eligible for Treg infusion:

  1. Received any vaccination within 14 days prior to blood collection for Treg manufacture;
  2. Unacceptable Treg product;
  3. Positive pregnancy test for women of child bearing potential.

mTOR Conversion Exclusion Criteria:

1. Post-transplant Donor-Specific Antibodies (DSA) >2000 mean florescence intensity (MFI).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02711826
Other Study ID Numbers  ICMJE DAIT CTOT-21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The plan is to share data in ImmPort [https://immport.niaid.nih.gov/ ], a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts, upon completion of the study.
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Clinical Trials in Organ Transplantation
Investigators  ICMJE
Principal Investigator: Flavio Vincenti, MD University of California at San Francisco
Study Chair: Sindhu Chandran, MD University of California at San Francisco
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP