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Study of tacrolimus, everolimus and mycophenolate mofetil combination in elderly patients after kidney transplant

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial focuses on patients who have received a kidney transplant. The study compares two different approaches to preventing organ rejection after transplantation. The medications being tested include tacrolimus, mycophenolate mofetil, and everolimus, which are drugs that help prevent the immune system from rejecting the transplanted kidney. Additional medications used in the study include prednisolone, basiliximab, and ciclosporin.

The purpose of this study is to determine if a lower dose of tacrolimus combined with everolimus works as well as the standard treatment using tacrolimus and mycophenolate mofetil in elderly transplant recipients. The study will monitor how well the transplanted kidney functions and track any complications that may occur over a two-year period after the transplant surgery.

During the study, participants will receive either the standard treatment or the new combination treatment. They will have regular check-ups to monitor their kidney function, measure drug levels in their blood, and assess their overall health. The study will track various aspects of the participants' health, including kidney function, infections, diabetes, and quality of life.

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 treatment after transplant
You will receive basiliximab through an infusion (Simulect 20 mg) after the kidney transplant surgery
You will start taking oral medications including tacrolimus (Envarsus 0.75 mg extended-release tablets), mycophenolate mofetil (Mycofenolaat mofetil 250 mg capsules), and prednisolone (5 mg tablets)
Step 2
Ongoing medication regimen
You will continue taking tacrolimus in combination with everolimus (Certican 0.75 mg tablets)
The treatment includes ciclosporin (Ciclosporine 25 mg soft capsules) as part of the medication plan
Regular blood tests will monitor your kidney function through a measurement called eGFR (estimated glomerular filtration rate, which shows how well your kidneys are working)
Step 3
Follow-up period
Your progress will be monitored for 24 months (2 years) after the transplant
Regular check-ups will assess your kidney function and overall health
Doctors will monitor for possible side effects and complications
Your quality of life and general well-being will be evaluated through questionnaires
Step 4
Final assessment
At the end of 24 months, a final evaluation will determine the success of your transplant
Success is measured by the survival of the transplanted kidney and its function level
Your kidney function will need to maintain specific levels depending on your assigned group (eGFR above 30 or 45 ml/min/1.73m2)

Who can join the trial?

6 criteria

You must provide written consent before any medical procedures or tests can begin
You must be 65 years or older, either male or female
You must be enrolled in the study within 24 hours after your kidney transplant surgery
For Group A patients: You must be receiving your first kidney transplant (or second if your first transplant wasn't rejected by your immune system) from a deceased donor who was 65 years or older
For Group B patients: You must be receiving your first kidney transplant (or second if your first transplant wasn't rejected by your immune system) from either:
- A deceased donor under 65 years of age, or
- A living donor of any age

Who cannot join the trial?

14 criteria

Age below 18 years old or above 65 years old
Currently pregnant or breastfeeding women
Previous organ transplant history
Active infections or serious medical conditions that could interfere with kidney transplantation
eGFR (estimated glomerular filtration rate - a measure of kidney function) less than 30 ml/min/1.73m² for standard risk patients
eGFR less than 45 ml/min/1.73m² for high-risk patients
Active cancer or history of cancer in the past 5 years
Severe heart disease or uncontrolled high blood pressure
Chronic liver disease or hepatitis
Uncontrolled diabetes
Substance abuse or addiction within the past 6 months
Mental conditions that may affect ability to follow study procedures
Participation in other clinical trials within the past 30 days
Known allergies to medications used in transplantation

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
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Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Katholieke Universiteit te Leuven
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Leuven, Belgium

Trial locations

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Investigated drugs

Tacrolimus
is a medication that helps prevent organ rejection after transplantation by suppressing the immune system. It helps protect the new kidney by preventing the body from attacking it.
Mycophenolate mofetil
is an immunosuppressant medication that works together with other drugs to prevent organ rejection after kidney transplantation. It helps reduce the risk of the body rejecting the new kidney.
Everolimus
is a medication that helps prevent rejection of transplanted organs. It works by decreasing certain immune cells in the body that could damage the new kidney. It is used in combination with other immunosuppressant medications.

What is already known about the treatment

Tacrolimus
An oral immunosuppressant medication primarily used to prevent organ rejection in kidney transplant patients. It works by inhibiting T-cell activation in the immune system, reducing the risk of transplant rejection. This calcineurin inhibitor is typically administered in capsule form twice daily, with dosing carefully monitored through blood level testing to maintain therapeutic effectiveness while minimizing side effects.
Mycophenolate mofetil
An immunosuppressive medication taken orally to prevent organ rejection in kidney transplant recipients. It works by blocking an enzyme needed for DNA synthesis in immune cells, thereby reducing their ability to attack the transplanted organ. The medication is usually taken twice daily in capsule or tablet form and is often used in combination with other anti-rejection medications.
Everolimus
An immunosuppressant medication used in kidney transplant patients to prevent organ rejection, administered orally in tablet form. It belongs to the class of drugs known as mTOR inhibitors and works by preventing the activation of immune cells that could attack the transplanted organ. This medication requires regular blood level monitoring and is often used in combination with reduced doses of other immunosuppressants.

Investigated diseases

End-Stage Renal Disease
A condition where the kidneys permanently lose their ability to filter waste from the blood, requiring either dialysis or kidney transplantation. The condition develops gradually as kidney function deteriorates over time. It affects how the body maintains proper fluid balance, produces hormones, and removes waste products.
Kidney Transplant Rejection
A process where the recipient's immune system recognizes the transplanted kidney as foreign and attacks it. This immune response can occur immediately after transplantation or develop over time. The body's defense mechanisms target the new kidney tissue, potentially affecting its function.
Chronic Kidney Disease
A progressive condition characterized by the gradual loss of kidney function over time. The kidneys become less efficient at filtering waste products from the blood. The condition can affect blood pressure regulation, red blood cell production, and bone health.
Post-Transplant Diabetes Mellitus
A form of diabetes that develops after organ transplantation, characterized by elevated blood sugar levels. This condition can develop due to the effects of immunosuppressive medications. It affects how the body processes glucose and requires careful monitoring of blood sugar levels.