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Study on Valsartan for Kidney Transplant Patients with Post-Transplant Glomerulopathy

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 is focused on studying the effects of a medication called Valsartan in patients who have received a kidney transplant. Kidney transplants are a treatment for patients with severe kidney disease, where a healthy kidney from a donor is placed into a patient whose kidneys are no longer functioning properly. After a kidney transplant, some patients may develop a condition known as post-transplant glomerulopathy, which affects the tiny filters in the kidney. This study aims to see if Valsartan, which is a type of medication known as an angiotensin II receptor antagonist, can help prevent a decrease in kidney function in these patients.

The purpose of the study is to evaluate whether treatment with Valsartan can prevent the drop in kidney function in kidney transplant patients who have certain cells, called progenitor cells, in their urine. These cells are thought to be involved in the repair and regeneration of kidney tissue. The study will compare the effects of Valsartan with a placebo to see if there is a significant difference in maintaining kidney function. Participants will take the medication orally, in the form of film-coated tablets, over a period of time as part of the study.

Throughout the study, participants will be monitored to assess their kidney function and overall health. The study will help determine if Valsartan is effective in supporting kidney health in transplant patients, potentially offering a new approach to managing post-transplant glomerulopathy. The findings from this study could provide valuable insights into improving the care and outcomes for kidney transplant recipients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the details and potential risks of the trial.
Step 2
Initial assessment
Your kidney function will be assessed to ensure it is stable. This is defined as a variation in estimated glomerular filtration rate (eGFR) of less than 15% in the last three months.
Your current medication regimen will be reviewed to confirm it includes maintenance immunosuppression based on tacrolimus and MMF/MPA.
Step 3
Medication administration
You will begin taking Valsartan STADA 80 mg film-coated tablets. This medication is taken orally.
The dosage and frequency of administration will be determined by the study protocol and communicated to you by the study team.
Step 4
Ongoing monitoring
Throughout the trial, your kidney function will be regularly monitored to evaluate the effect of the medication.
You will be required to attend scheduled visits for assessments and to report any side effects or changes in your health.
Step 5
Completion of the trial
The trial is expected to continue until January 1, 2027. Upon completion, your participation in the study will end, and you will receive information about the results and any further steps if necessary.

Who can join the trial?

5 criteria

Provide written informed consent, which means you agree to participate in the study after being fully informed about it.
Have stable kidney function, meaning your estimated glomerular filtration rate (eGFR) has changed by less than 15% in the last 3 months. eGFR is a test that measures how well your kidneys are working.
Be on a maintenance immunosuppression treatment plan that includes the medications tacrolimus and MMF/MPA. These medications help prevent your body from rejecting the transplanted kidney.
Be within the age range of 18 to 65 years old.
Both male and female participants are eligible.

Who cannot join the trial?

3 criteria

Patients who have had a kidney transplant cannot participate.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Verified sites

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Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain

Trial locations

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Investigated drugs

Angiotensin II Receptor Antagonist (ARB) is a type of medication used in this clinical trial. It works by blocking the action of a natural substance in your body called angiotensin II. This substance usually makes your blood vessels tighten, which can increase blood pressure. By blocking it, the medication helps to relax and widen your blood vessels, which can lower blood pressure and improve blood flow. In this trial, the ARB is being tested to see if it can help protect kidney function in patients who have had a kidney transplant and have specific cells, called renal progenitor cells, in their urine. The goal is to see if this medication can prevent a decrease in how well the kidneys filter waste from the blood.

Valsartan

What is already known about the treatment

Angiotensin II Receptor Antagonist (ARB) – This medication is typically taken orally and works by blocking the action of a hormone called angiotensin II, which helps relax blood vessels and lower blood pressure. It is currently being studied in clinical trials for its potential benefits in kidney transplant patients, specifically those with certain cells in their urine that may indicate kidney issues. The main goal of using this medication in these patients is to prevent a decrease in kidney function. It belongs to a class of drugs known as antihypertensives, which are commonly used to manage high blood pressure.

Investigated diseases

Chronic Kidney Disease in Renal Transplant Patients – Chronic kidney disease in renal transplant patients involves the gradual loss of kidney function over time in individuals who have received a kidney transplant. This condition can occur due to various factors, including immune responses, infections, or damage to the transplanted kidney. As the disease progresses, the kidneys become less effective at filtering waste and excess fluids from the blood. Patients may experience symptoms such as fatigue, swelling, and changes in urine output. Over time, the decline in kidney function can lead to complications affecting other organs and systems in the body. Monitoring and managing kidney function is crucial to slow the progression of the disease.