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Study on Finerenone for Slowing Chronic Kidney Disease Progression in Patients Receiving Standard Care

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What is this study about?

This clinical trial is focused on studying Chronic Kidney Disease and aims to explore the effects of a treatment called Finerenone, which is provided in the form of a film-coated tablet. The study will compare the effects of Finerenone to a placebo in patients who are already receiving standard care for their condition. The main goal is to find out if Finerenone can help slow down the progression of the disease by reducing the rate at which kidney function declines.

Participants in the study will take either Finerenone or a placebo orally for a period of up to 104 weeks, which is about two years. Throughout the study, the health of the participants will be monitored to see how their kidney function changes over time. The study will also look at other health outcomes, such as changes in protein levels in the urine, the occurrence of kidney failure, and any cardiovascular events like heart attacks or strokes.

The study will also assess the safety and tolerability of the treatment, as well as its impact on the quality of life of the participants. By the end of the study, researchers hope to determine whether Finerenone is an effective treatment option for people with Chronic Kidney Disease and if it can be used to improve their overall health outcomes.

1 randomization

Upon joining the study, participants are randomly assigned to receive either the investigational medication finerenone or a placebo. This process ensures that the study results are unbiased and reliable.

2 medication administration

Participants take the assigned medication orally in the form of a film-coated tablet. The dosage and frequency are determined by the study protocol and the treating physician.

The medication is taken regularly as part of the participant’s daily routine, alongside their standard care treatment for chronic kidney disease.

3 monitoring and assessments

Participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes measuring the rate of decline in kidney function, known as eGFR (estimated glomerular filtration rate), over a period of 108 weeks.

Additional assessments include changes in albuminuria, which is the presence of albumin in the urine, and monitoring for any cardiovascular events or changes in quality of life.

4 follow-up visits

Participants attend scheduled follow-up visits at regular intervals throughout the study. These visits are essential for collecting data on kidney function, overall health, and any side effects experienced.

The study aims to determine if the investigational medication can slow the progression of chronic kidney disease compared to the placebo.

5 study completion

The study concludes after 108 weeks of treatment and monitoring. Participants may be asked to attend a final visit to assess their health and discuss the study’s outcomes.

The data collected during the study will contribute to understanding the potential benefits and risks of the investigational medication for individuals with chronic kidney disease.

Who Can Join the Study?

  • Must be 18 years or older.
  • Have chronic kidney disease from any cause, with a measure called eGFR (estimated glomerular filtration rate) of 25 or more. This is a test that shows how well your kidneys are working.
  • Currently receiving standard treatment for chronic kidney disease as advised by your doctor.
  • Eligible to be randomly assigned to different parts of the study.
  • Both you and your doctor must be willing and able to follow the study procedures.
  • Have a urine albumin-creatinine ratio (uACR) greater than 200 mg/g or a urine protein-creatinine ratio (uPCR) greater than 300 mg/g from a recent test in the last 3 months. These tests measure protein levels in your urine.
  • On a stable standard treatment for chronic kidney disease, including a type of medication called SGLT2 inhibitor, unless there’s a documented reason not to use it, for at least 4 weeks before the study starts.
  • Your doctor believes that a medication called finerenone is suitable for you.
  • Both you and your doctor must be willing and able to follow specific procedures related to a type of medication called Mineralocorticoid Receptor Antagonist.

Who Cannot Join the Study?

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a kidney transplant.
  • Patients who are currently participating in another clinical trial.
  • Patients who have allergies to the study medication.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver disease.
  • Patients with a history of heart attack or stroke in the past six months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola Rome Italy
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Agfjxib Ojnrzlyacqmixplqojfutzktt Df Ciitodg Cosenza Italy
Akjtztw Ofdvkxembmw Ueyxddsnlgvpg Oebriswn Rzkndtx Foggia Italy
Aofjjbc Uej Iiqiw Df Rcusbh Ejvujx Reggio Emilia Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
01.09.2024

Trial locations

Investigated drugs:

Investigational Agents
These are new or experimental medications being tested in the trial to see if they can help slow down the progression of chronic kidney disease. They are not yet approved for general use and are being studied to understand their effects and safety in patients with this condition.

Investigated diseases:

Chronic Kidney Disease – Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This disease progresses slowly over time, often without noticeable symptoms in the early stages. As kidney function declines, waste products can build up in the body, leading to symptoms such as fatigue, swelling, and changes in urination. The progression of the disease can lead to complications like high blood pressure, anemia, and bone disease. In advanced stages, the kidneys may fail completely, requiring dialysis or a kidney transplant. Monitoring kidney function and managing risk factors can help slow the progression of the disease.

Trial ID:
2024-511325-67-00
Protocol code:
P01351
NCT ID:
NCT06058585
Trial Phase:
Therapeutic confirmatory (Phase III)

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