Study on Reducing Tacrolimus in Kidney Transplant Patients with Low Immunological Risk Using Tacrolimus, Mycophenolic Acid, and Prednisone

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What is this study about?

This clinical trial is focused on patients who have undergone a kidney transplantation. The study is investigating the effects of reducing the use of a medication called tacrolimus, which is commonly used to help prevent the body from rejecting a transplanted kidney. The trial will compare the outcomes of patients who receive a lower dose of tacrolimus with those who continue with the standard dose. The goal is to see if reducing tacrolimus can maintain kidney function while minimizing potential side effects.

Participants in the study will be randomly assigned to one of two groups. One group will receive a minimized dose of tacrolimus, while the other group will continue with the standard treatment. The study will also involve the use of other medications, such as Myfortic (containing mycophenolic acid), CellCept (containing mycophenolate mofetil), and corticosteroids like prednisone and prednisolone. Additionally, a contrast agent called iohexol will be used to assess kidney function. The study will last for 18 months, during which time participants will have regular check-ups to monitor their health and the function of their transplanted kidney.

The purpose of this study is to determine if a lower dose of tacrolimus can effectively support kidney function while reducing the risk of side effects. By the end of the study, researchers hope to gather valuable information on the best way to manage medications for kidney transplant recipients, potentially leading to improved outcomes and quality of life for these patients.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current medications.

A kidney biopsy may be performed to ensure normal or specific histology is present.

2 medication regimen

Participants will continue their current medication regimen, which includes tacrolimus (either Prograf or Advagraf), mycophenolic acid or mycophenolate mofetil, and possibly a corticosteroid.

The dosage and frequency of these medications will be determined by the study protocol and adjusted as necessary.

3 tacrolimus minimization

The study aims to minimize the dosage of tacrolimus using a specific algorithm. This process will be monitored closely to ensure kidney function is maintained.

Regular blood tests will be conducted to measure tacrolimus levels and adjust the dosage accordingly.

4 regular follow-up visits

Participants will attend regular follow-up visits to monitor kidney function and overall health. These visits will occur at specified intervals over an 18-month period.

During these visits, various assessments will be conducted, including blood tests and possibly additional kidney biopsies.

5 quality of life assessments

Participants will complete a quality of life questionnaire at several points during the study: at the start, and then at 3, 6, 9, 12, 15, and 18 months.

This questionnaire helps evaluate the impact of the treatment on daily life and well-being.

6 final evaluation

At the end of the 18-month period, a final evaluation will be conducted to assess kidney function and overall health.

The results will be compared to initial assessments to determine the impact of tacrolimus minimization.

Who Can Join the Study?

Must be an adult patient.
Must be treated with Tacrolimus (a medication used to prevent organ rejection) and MMF/MPS, with or without Corticosteroid (CS).
Must have had their first kidney transplantation.
Donor can be living, brain dead, or deceased (Maastricht 3).
Must be compatible for ABO blood group with the donor.
Must be one year post kidney transplantation (between 350 and 515 days after the transplantation).
Must have a cPRA (calculated Panel Reactive Antibody) or TGI (Transplant Glomerulopathy Index) less than 20% on the day of transplantation and no DSA (Donor-Specific Antibodies) with MFI (Mean Fluorescence Intensity) less than 500 before transplant and at the time of inclusion one year post-transplantation.
Must have normal or IFTA 1-2 histology (a type of tissue examination) on one-year surveillance biopsy.
Must be insured under a health insurance scheme, according to national regulation.
If of childbearing age, must use effective contraception (such as sexual abstinence, use of a condom with spermicide, contraceptive sponge, uterine diaphragm, hormonal contraception, or intrauterine contraceptive device) throughout the entire study period.

Who Cannot Join the Study?

Patients who have not had a kidney transplant cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes young adults and middle-aged adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Oslo University Hospital HF	Oslo	Norway
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hyrtbthl Vwan debbiecx	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.11.2023
Norway	Recruiting	02.11.2023
Spain	Recruiting	02.11.2023

Trial locations

Investigated drugs:

Tacrolimus is a medication used to help prevent the body from rejecting a transplanted kidney. It works by suppressing the immune system, which is the body’s natural defense system. In this clinical trial, the researchers are studying how reducing the amount of tacrolimus affects kidney function in patients who have received a kidney transplant. The goal is to see if using less of this medication can still protect the transplanted kidney while possibly reducing side effects associated with the drug.

Investigated diseases:

Renal transplant

Kidney Transplantation – Kidney transplantation is a medical procedure where a healthy kidney from a donor is placed into a person whose kidneys are no longer functioning properly. After transplantation, the new kidney takes over the work of filtering blood and producing urine. Over time, the body may recognize the new kidney as foreign, leading to immune responses that can cause rejection. Rejection can manifest as inflammation and damage to the kidney tissue, potentially affecting its function. The progression of kidney function post-transplant is monitored through various tests, including measuring the glomerular filtration rate. Maintaining the health of the transplanted kidney involves careful management of immune responses and monitoring for any signs of rejection or other complications.

Trial ID:

2022-502624-44-00

Protocol code:

RC22-0525

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reducing Tacrolimus in Kidney Transplant Patients with Low Immunological Risk Using Tacrolimus, Mycophenolic Acid, and Prednisone

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?