Kidney Transplantation, Mycophenolate Mofetil
Conditions
Keywords
Kidney Transplant
Brief summary
The purpose of this research is to determine the safety and efficacy of withdrawing MMF (Mycophenolate Mofetil) in kidney transplant recipients who are 55 years or older at the time of receiving a kidney transplant. We are comparing them to patients who receive the standard of care Mycophenolate Mofetil.
Detailed description
Participation will be two years and it involves blood collection, collection of medical information and images from standard of care kidney biopsies. Subjects will be asked to complete questionnaires for the study at 12 and 24 months after kidney transplant. The research blood tests that are being collected for the study are called Trugraf®, Eurofins TRAC®, Trac-ID and Immunophenotyping and Single Cell RNA -sequencing. The principal investigator is using this test to see if they can predict and monitor rejection and viral infections in our kidney transplant patients. Immunophenotyping and single cell RNA sequencing tests are being done to identify unique gene expression profiles and their functions in different immune cells. At the time of the 4 month standard of care follow up visit, if participants have not experienced any rejection episodes or formed any donor specific antibodies (dnDSA) and are still eligible, randomization will occur. Participants will be put into 1 of 2 groups: Mycophenolate Mofetil Maintenance group where the subject would continue on current medication, or the subject will be placed into the MMF Withdrawal group which means they would slowly be withdrawn from this medication. If the subject is not eligible to be randomized, they will remain in the study and placed into the Non-Randomized group and continue to have study related visits and procedures like the MMF Maintenance group.
Interventions
DRUGMycophenolate Mofetil (MMF) Maintenance Group
Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Maintenance in Immunosuppression medication.
DRUGMycophenolate Mofetil (MMF) Withdrawal Group
Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Withdrawal of MMF immunosuppression medication.
Sponsors
Mayo Clinic
Transplant Genomics, Inc.
Eurofins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Solitary kidney transplant recipient \>55 years of age. At most 1 prior solitary kidney transplant. * No other solid organ transplant though recipients of autologous stem cell transplants are eligible. * HIV negative. * Subjects must be on tacrolimus and mycophenolate mofetil or Myfortic at the time of consent. Prednisone at the time of consent is optional and is per local standard of care. Patients randomized to MMF withdrawal will be placed on prednisone 5mg/d at 4 months. Use of other immunosuppression medications for maintenance (cyclosporine, azathioprine, belatacept, sirolimus) is excluded.
Exclusion criteria
Time of Transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Rejection | 4 to 24 months post transplant. | Total number of subjects to experience acute rejection of the renal transplant |
| Patient Deaths | 4 to 24 months post transplant. | Total number of subject deaths from 4-24 months post transplant. |
| Graft Failure | 4 to 24 months post transplant. | Total number of subjects to experience graft failure from the renal transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events (SAE) | 1 and 2 years post transplant. | The total number of subjects to experience SAE's. Defined as subjects experience any one of the following: acute cellular or antibody medicated rejection, borderline rejection or dnDSA (De novo donor-specific antibodies) |
| eGFR (estimated glomerular filtration rate) | 2 years post transplant | eGFR is calculated from a lab blood test using a formula that measures the level of creatinine. In this test a higher number is better. An eGFR value lower than 60 is a sign that the kidneys may not be working properly. Measured as mL/min/1 |
| Single antigen beads (SAB) for donor-specific antibodies | Baseline, 1 year post transplant and 2 years post transplant | Single antigen bead (SAB) assay is a lab blood test used to detect human leukocyte antigen antibodies (HLA) and assessing the immunological risk for organ transplant. For HLA-DRβ1/3/4/5 the single molecule mismatches can range from 0-22 and for HLA-DQα1/β1 the single molecule mismatches range from 0-31. Measured as pg/mL. |
| BANFF scores | 2 years post transplant. | The Banff 2018 classification involves scoring numerous characteristics of renal biopsy specimens. The scores can take values of 0, 1, 2, or 3 for each characteristic, indicating increasing severity of disease as the scores increase. |
| Absolute lymphocyte counts | 1 year post transplant and 2 years post transplant | An absolute lymphocytes count is determined by multiplying the total number of white blood cells by the percentage of white blood cells that are lymphocytes. The normal range for lymphocytes is between 800 and 5000 (0.8-5.0) lymphocytes per mL of blood. A normal lymphocytes percentage is 18-45% of total white blood cells. Measured as cells per microliter (cells/µL) |
| Transplant Related Symptom (CIRS) Questionnaire | 2 years post transplant. | The CIRS questionnaire is a 36-item questionnaire that contains statements that rate transplant symptoms on a scale of 1(None) to 5 (Very Severe). Total scores range from 36-180, lower scores indicate less severe symptoms, higher scores indicate more severe symptoms. |
| Albumin/Creatinine Ratio (Microalbumin) Urine | 2 years post transplant | The urine albumin-creatinine ratio (uACR) test measures the amount of two different substances in urine - albumin (a protein) and creatinine. A value of 30 or higher suggests a higher risk for kidney failure. Measured as mg/g |
Countries
United States
Contacts
CONTACTNong Yowe Braaten, LPN
CONTACTEsma Kesik, M.D.
PRINCIPAL_INVESTIGATORMark D Stegall, M.D.
Mayo Clinic
Outcome results
None listed