Kidney Transplant RejectionMISSIONNCT04953715
Microbiome and Immunosuppression: The Mission Study
An observational study of Kidney Transplant Rejection and Kidney Transplant, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection, Kidney Transplant
- What is being tested?
- collection of body microbiome
- Type of treatment
- Pill or oral medicine
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2020to 1 Jan 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants undergoing kidney transplant
- Male or female at least 18 years of age at time of enrollment
- Will or have received a living or deceased donor kidney transplant
- 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).
- Able and willing to complete study-related procedures and visits
- Signs written informed consent
Who cannot join
- Recipient of a previous non-kidney transplant
- Subject is a multi-organ transplant recipient
- Presence of active gastroparesis, and documented in the medical record
- Liver dysfunction (total bilirubin >2x upper limit of normal) within 2 months of enrollment
- Patients who take medications that significantly inhibit uridine 5'-diphosphate glucuronosyltransferase (UGT) enzymes.
- Patients who take medications that significantly inhibit or induce the biliary transporters
Show all 10Show fewer
- Patient is known to be HIV positive
- Pregnant or nursing (lactating) women
- Non-English speaking
- Patients who have undergone bariatric surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota
Minneapolis, Minnesota, 55414
HCMC
Minneapolis, Minnesota, 55415
About this study
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. The study team wants to study how the microbiome affects how the body processes the transplant medication.
Read the 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. The study team wants to study what impact these changes to the microbiome have on the individual. The study team is specifically interested in how these changes to the microbiome may change the metabolism (breakdown) and action of medications. It is already known that individual genetics impact the metabolism, absorption, and toxicities of some medications. It is suspected that 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, providers can more accurately prescribe and dose these medications to better treat and care for transplant patients and their organs.
It is expected that participants will be in this research study for up to 12 years. There will be periods of time that requires active participation (visits) and periods of time that will be more passive participation (allowing study staff to follow-up with medical records for outcomes).
- Conditions
- Kidney Transplant Rejection, Kidney Transplant
- Being tested
- collection of body microbiome
- Keywords
- transplant, kidney, Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of body microbiomeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: collection of body microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the relationship between transplant graft outcomes and urinary transcriptome.
The gut microbiome has been implicated in the Stool from tx recipients with diarrhea is often sent for testing of potential pathogenic organisms. polymerase chain reaction (PCR)- based approaches to identify etiology of post-tx diarrhea only tests for a limited number of organisms.
Measured: 5 years
To assess the relationship between kidney graft outcomes and stool, oral, nasal, and urine microbiome diversity.
The gut microbiome has been implicated in the variability in metabolism of drugs with specific microbial species being associated with direct and indirect effects.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start12 Feb 2020
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Israni, MD, Principal investigator, University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953715
- Sponsor's protocol ID
- 24-0273
- Other IDs
- R01AI140303, "MISSION" study, K01AI199717-01
- Acronym
- MISSION
- Status last verified
- Aug 2026
- First submitted
- 28 Jun 2021
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohamed ME, Saqr A, Onyeaghala G, Remmel RP, Staley C, Dorr CR, Teigen L, Guan W, Vo D, El-Rifai R, Oetting WS, Matas AJ, Israni AK, Jacobson PA. A Mycophenolate Pharmacokinetic Study with New Insights into Enterohepatic Recirculation in Kidney Transplant Recipients. Clin Pharmacokinet. 2026 Mar;65(3):479-495. doi: 10.1007/s40262-025-01611-3. Epub 2026 Feb 6.
PubMed 41649771Mohamed ME, Saqr A, Onyeaghala G, Remmel RP, Staley C, Dorr CR, Teigen L, Guan W, Madden H, Munoz J, Sanchez B, Vo D, El-Rifai R, Oetting WS, Matas AJ, Israni AK, Jacobson PA. Simultaneous Prediction of Area Under the Curves of Mycophenolic Acid and Its Metabolites and Enterohepatic Recirculation in Kidney Transplant Recipients. Ther Drug Monit. 2025 Dec 1;47(6):799-808. doi: 10.1097/FTD.0000000000001336. Epub 2025 Apr 30.
PubMed 40315256Mohamed ME, Saqr A, Al-Kofahi M, Onyeaghala G, Remmel RP, Staley C, Dorr CR, Teigen L, Guan W, Madden H, Munoz J, Vo D, Sanchez B, El-Rifai R, Oetting WS, Matas AJ, Israni AK, Jacobson PA. Limited Sampling Strategies Fail to Accurately Predict Mycophenolic Acid Area Under the Curve in Kidney Transplant Recipients and the Impact of Enterohepatic Recirculation. Ther Drug Monit. 2025 Feb 1;47(1):174-182. doi: 10.1097/FTD.0000000000001248. Epub 2024 Jul 23.
PubMed 39047238Khan MH, Onyeaghala GC, Rashidi A, Holtan SG, Khoruts A, Israni A, Jacobson PA, Staley C. Fecal beta-glucuronidase activity differs between hematopoietic cell and kidney transplantation and a possible mechanism for disparate dose requirements. Gut Microbes. 2022 Jan-Dec;14(1):2108279. doi: 10.1080/19490976.2022.2108279.
PubMed 35921529
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome and Immunosuppression: The Mission Study
- ClinicalTrials.gov ID
- NCT04953715
- Acronym / sponsor ID
- MISSION / 24-0273
- Conditions
- Kidney Transplant Rejection, Kidney Transplant
- Keywords
- transplant, kidney, Microbiome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2033 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The study team wants to study how the microbiome affects how the body processes the transplant medication.
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. The study team wants to study what impact these changes to the microbiome have on the individual. The study team is specifically interested in how these changes to the microbiome may change the metabolism (breakdown) and action of medications. It is already known that individual genetics impact the metabolism, absorption, and toxicities of some medications. It is suspected that 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, providers can more accurately prescribe and dose these medications to better treat and care for transplant patients and their organs.
It is expected that participants will be in this research study for up to 12 years. There will be periods of time that requires active participation (visits) and periods of time that will be more passive participation (allowing study staff to follow-up with medical records for outcomes).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 - This is a multicenter microbiome and pharmacokinetic study. | – | Other: collection of body microbiomeA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Participants undergoing kidney transplant
- Male or female at least 18 years of age at time of enrollment
- Will or have received a living or deceased donor kidney transplant
- 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).
- Able and willing to complete study-related procedures and visits
Key exclusion criteria (10 listed)
- Recipient of a previous non-kidney transplant
- Subject is a multi-organ transplant recipient
- Presence of active gastroparesis, and documented in the medical record
- Liver dysfunction (total bilirubin >2x upper limit of normal) within 2 months of enrollment
- Patients who take medications that significantly inhibit uridine 5'-diphosphate glucuronosyltransferase (UGT) enzymes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of body microbiomeA 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. | Other | 1 - This is a multicenter microbiome and pharmacokinetic study. |
Primary outcome
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. polymerase chain reaction (PCR)- based approaches to identify etiology of post-tx diarrhea only tests for a limited number of organisms.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 41649771Mohamed ME, Saqr A, Onyeaghala G, Remmel RP, Staley C, Dorr CR, Teigen L, Guan W, Vo D, El-Rifai R, Oetting WS, Matas AJ, Israni AK, Jacobson PA. A Mycophenolate Pharmacokinetic Study with New Insights into Enterohepatic Recirculation in Kidney Transplant Recipients. Clin Pharmacokinet. 2026 Mar;65(3):479-495. doi: 10.1007/s40262-025-01611-3. Epub 2026 Feb 6.
- Background: PubMed 40315256Mohamed ME, Saqr A, Onyeaghala G, Remmel RP, Staley C, Dorr CR, Teigen L, Guan W, Madden H, Munoz J, Sanchez B, Vo D, El-Rifai R, Oetting WS, Matas AJ, Israni AK, Jacobson PA. Simultaneous Prediction of Area Under the Curves of Mycophenolic Acid and Its Metabolites and Enterohepatic Recirculation in Kidney Transplant Recipients. Ther Drug Monit. 2025 Dec 1;47(6):799-808. doi: 10.1097/FTD.0000000000001336. Epub 2025 Apr 30.
- Background: PubMed 39047238Mohamed ME, Saqr A, Al-Kofahi M, Onyeaghala G, Remmel RP, Staley C, Dorr CR, Teigen L, Guan W, Madden H, Munoz J, Vo D, Sanchez B, El-Rifai R, Oetting WS, Matas AJ, Israni AK, Jacobson PA. Limited Sampling Strategies Fail to Accurately Predict Mycophenolic Acid Area Under the Curve in Kidney Transplant Recipients and the Impact of Enterohepatic Recirculation. Ther Drug Monit. 2025 Feb 1;47(1):174-182. doi: 10.1097/FTD.0000000000001248. Epub 2024 Jul 23.
- Background: PubMed 35921529Khan MH, Onyeaghala GC, Rashidi A, Holtan SG, Khoruts A, Israni A, Jacobson PA, Staley C. Fecal beta-glucuronidase activity differs between hematopoietic cell and kidney transplantation and a possible mechanism for disparate dose requirements. Gut Microbes. 2022 Jan-Dec;14(1):2108279. doi: 10.1080/19490976.2022.2108279.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Israni, MD principal investigator
University of Texas Medical Branch, Galveston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection and Kidney Transplant, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the relationship between transplant graft outcomes and urinary transcriptome. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04953715, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.