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Microbiome and Immunosuppression: The Mission Study (MISSION)

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ClinicalTrials.gov Identifier: NCT04953715
Recruitment Status : Recruiting
First Posted : July 8, 2021
Last Update Posted : July 8, 2021
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Ajay Israni, Hennepin Healthcare Research Institute

Brief Summary:
The purpose of this research is to study immunosuppression drugs, certain foods, and how they can change the microbiome (the natural microorganisms inside the body) of the individual taking the immunosuppressive medications. We want to study how the microbiome affects how your body process the transplant medication.

Condition or disease Intervention/treatment
Kidney Transplant Rejection Kidney Transplant Other: collection of body microbioma

Detailed Description:

Immunosuppression drugs, like antibiotics and certain foods, can change the microbiome (the natural micro-organisms inside the body) of the individual taking the drug. We want to study what impact these changes to the microbiome have on the individual. We are specifically interested in how these changes to the microbiome may change the metabolism (breakdown) and action of medications. We already know that individual genetics impact the metabolism, absorption, and toxicities of some medications. We suspect the microbiome will have similar impacts on medications.With a better understanding of how individual microbiome impacts immunosuppressant medications used to help transplant recipients from rejecting their new organs, we can more accurately prescribe and dose these medications to better treat and care for our transplant patients and their organs.

We expect that you will be in this research study for up to 12 years. There will be periods of time that require your active participation (visits) and periods of time that will be more passive participation (allowing our study staff to follow-up your medical records for outcomes).

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbiome and Immunosuppression: The Mission Study
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : January 1, 2032
Estimated Study Completion Date : January 1, 2033

Group/Cohort Intervention/treatment
1 - This is a multicenter microbiome and pharmacokinetic study.
A prospective, observational microbiome study of adult kidney transplant recipients receiving mycophenolate mofetil and tacrolimus maintenance immunosuppression. Participants will be studied post-transplant for mycophenolate pharmacokinetics and microbiome samples collected. Clinically measured tacrolimus trough concentrations will also be evaluated. Associations among mycophenolic acid enterohepatic recycling and metabolite formation, tacrolimus troughs, immunosuppression adverse effects, diarrhea and microbiome will be studied. To assess the relationship between kidney graft outcomes and stool, oral, nasal and urine microbiome diversity. To assess the relationship between transplant graft outcomes and urinary transcriptome.
Other: collection of body microbioma
A prospective, observational microbiome study of adult kidney transplant recipients receiving mycophenolate mofetil and tacrolimus maintenance immunosuppression. Participants will be studied post-transplant for mycophenolate pharmacokinetics and microbiome samples collected. Clinically measured tacrolimus trough concentrations will also be evaluated. Associations among mycophenolic acid enterohepatic recycling and metabolite formation, tacrolimus troughs, immunosuppression adverse effects, diarrhea and microbiome will be studied.




Primary Outcome Measures :
  1. To assess the relationship between transplant graft outcomes and urinary transcriptome. [ Time Frame: 5 years ]
    The gut microbiome has been implicated in the Stool from tx recipients with diarrhea is often sent for testing of potential pathogenic organisms. PCR based approaches to identify etiology of posttx diarrhea only tests for a limited number of organisms.

  2. To assess the relationship between kidney graft outcomes and stool, oral, nasal and urine microbiome diversity. [ Time Frame: 5 years ]
    The gut microbiome has been implicated in the variability in metabolism of drugs with specific microbial species being associated with direct and indirect effects.


Biospecimen Retention:   Samples With DNA
DNA from whole blood, microbiome stool and oral samples will be processed and stored


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults kidney transplant recipients with a planned immunosuppression regimen of mycophenolate mofetil dosed every 12 hours and immediate release tacrolimus dosed twice daily.
Criteria

Inclusion Criteria:

  • 1) Participants undergoing kidney transplant 2) Male or female at least 18 years of age at time of enrollment 3) Will or have received a living or deceased donor kidney transplant 4) Planned post-transplant immunosuppression regimen of mycophenolate mofetil dosed every 12 hours (Cellcept or generic) and immediate release tacrolimus dosed twice daily with trough concentration monitoring (generic or brand formulation).

    5) Able and willing to complete study-related procedures and visits 6) Signs written informed consent

Exclusion Criteria:

  • 1) Recipient of a previous non-kidney transplant 2) Subject is a multi-organ transplant recipient 3) Presence of active gastroparesis and documented in medical record 4) Liver dysfunction (total bilirubin >2x upper limit of normal) within 2 months of enrollment 5) Patients that take medications that significantly inhibit UGT enzymes. 6) Patients that take medications that significantly inhibit or induce the biliary transporters 7) Patient is known to be HIV positive 8) Pregnant or nursing (lactating) women 9) Non-English speaking 10) Patients who have undergone bariatric surgery

Information from the National Library of Medicine

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): NCT04953715


Contacts
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Contact: Ajay Israni, MD 6128736994 Ajay.Israni@hcmed.org
Contact: Yuliya Doronin, MD 6128733581 ydoronin@hhrinstitute.org

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Pamala Jacobson, PharmD, FCCP    612-624-6118    jacob117@umn.edu   
HCMC Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Ajai Israni, MD    612-873-6994    Ajay.Israni@hcmed.org   
Contact: Yuliya Doronin, MD    6128733581    ydoronin@hhrinstitute.org   
Sponsors and Collaborators
Ajay Israni
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Ajay Israni, MD Hennepin Healthcare Research Institute
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Responsible Party: Ajay Israni, Ajay Israni, M.D., M.S. Nephrologist, Hennepin Healthcare President, Hennepin Healthcare Research Institute (www.hhrinstitute.org/) Professor of Medicine Adjunct Faculty School of Public Health, University of Minnesota., Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT04953715    
Other Study ID Numbers: "MISSION" study
R01AI140303 ( U.S. NIH Grant/Contract )
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ajay Israni, Hennepin Healthcare Research Institute:
transplant
kidney
Microbiome