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Study of Mycophenolate and Tacrolimus Effects on Gut Microbiome in Kidney Transplant Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients who have received a kidney transplant and are taking immunosuppressive medications to prevent organ rejection. The medications being studied are mycophenolate mofetil (CellCept) and tacrolimus (Prograf), which are commonly used after transplantation to suppress the immune system and help prevent the body from rejecting the new organ.

The purpose of this research is to understand how these medications interact with the bacteria naturally present in the digestive system (known as the gut microbiome). The study will examine how these beneficial bacteria in the gut may affect the way the body processes these transplant medications. Participants will receive standard doses of both medications - up to 2000 mg per day of mycophenolate mofetil and up to 30 mg per day of tacrolimus.

The study will last for 12 months, during which researchers will monitor how the medications work in the body and how they affect the natural bacteria in the digestive system. Both medications will be taken by mouth. The medications used in this study are already approved for use in transplant patients and are part of standard care after kidney transplantation.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medication regimen
You will receive two medications as part of your treatment after kidney transplantation:
- CellCept (mycophenolate mofetil) 500 mg tablets taken by mouth
- Prograf (tacrolimus) 1 mg capsules taken by mouth
Step 2
First week monitoring
During the first week of treatment, your body's response to both medications will be monitored
Blood samples will be collected to measure the amount of medication in your system
Tests will be conducted to examine how your body processes the medications
Step 3
Ongoing assessments
Regular blood tests will be performed to check:
- The levels of medications in your blood
- Your body's immune response
- The presence of certain viruses
Samples will be collected to monitor how your body responds to the treatment
Step 4
Long-term follow-up
Your progress will be monitored until December 2028
Regular check-ups will assess:
- How well the transplanted kidney is working
- Any side effects from the medications
- Your overall health status

Who can join the trial?

10 criteria

Must be receiving a first-time kidney transplant with standard risk
Must be scheduled to receive tacrolimus (an anti-rejection medication) and mycophenolate mofetil (another anti-rejection medication) after transplant
Can receive a kidney from either a deceased or living adult donor
Must have ABO-compatible transplantation (meaning the blood type of donor and recipient match)
Must have a PRA level of 20% or less (PRA measures antibodies that could react against donor tissues)
Must be DSA negative (meaning no donor-specific antibodies are present that could attack the transplanted kidney)
Must be an adult (18 years or older)
Can be either male or female
Must be willing and able to provide informed consent
Must be able to follow the treatment plan and attend follow-up visits

Who cannot join the trial?

13 criteria

Age below 18 years or above 65 years
Currently pregnant or breastfeeding women
Patients who have had multiple organ transplants
Patients taking antibiotics within the last 30 days
Patients with active infections or inflammatory bowel conditions
Patients with severe kidney dysfunction (poor kidney function requiring dialysis)
Patients who have received a kidney transplant less than 3 months ago
Patients with known allergies to mycophenolate (anti-rejection medication)
Patients unable to provide informed consent
Patients with significant liver disease
Patients participating in other clinical trials
Patients with severe digestive system disorders that could affect drug absorption
Patients who have recently changed their immunosuppressive medication regimen

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Verified sites

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Oslo Universitetssykehus HF
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Oslo, Norway

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Investigated drugs

Mycophenolate is an immunosuppressive medication that helps prevent organ rejection in transplant patients by reducing the activity of the immune system. It works by blocking an enzyme that immune cells need to multiply. The medication is being studied to understand how it interacts with the natural bacteria in the digestive system (gut microbiome) and how these bacteria might affect how the body processes the medication.

What is already known about the treatment

Mycophenolate - An immunosuppressive medication administered orally in tablet or capsule form, widely used in transplant medicine, particularly for preventing organ rejection after kidney transplantation. The drug works by inhibiting an enzyme called inosine monophosphate dehydrogenase, which is crucial for the production of new DNA in rapidly dividing cells like T and B lymphocytes, thereby suppressing the immune system's response. As part of the antiproliferative immunosuppressant class of medications, mycophenolate has become a cornerstone in transplant medicine, with extensive clinical evidence supporting its effectiveness in preventing organ rejection when used as part of a combination immunosuppressive regimen.

Investigated diseases

End-stage Renal Disease
A condition where kidneys permanently lose their ability to filter waste from the blood, requiring kidney transplantation or dialysis. The disease develops gradually as kidney function deteriorates over time, leading to fluid retention, electrolyte imbalances, and accumulation of waste products in the body. Patients experience various symptoms including fatigue, swelling, and changes in urination patterns.
Kidney Transplant Status
A medical condition following surgical replacement of a non-functioning kidney with a healthy donor kidney. After transplantation, the body needs to adapt to the new organ, requiring careful monitoring of organ function and immune system response. The body's immune system naturally recognizes the new kidney as foreign tissue, which necessitates ongoing management to maintain the transplanted organ's function.