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Study on the Effects of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease and High Protein Levels

Fast replyRegistered 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 Chronic Kidney Disease (CKD) in patients who have high levels of protein in their urine, a condition known as High Proteinuria. The study is testing a new treatment that combines two medications: Zibotentan and Dapagliflozin. These medications are taken together in a single pill, known as a fixed-dose combination, and will be compared to taking Dapagliflozin alone. The purpose of the study is to see if the combination of these two medications can better slow down the decline in kidney function compared to using Dapagliflozin by itself.

Participants in the study will be randomly assigned to receive either the combination of Zibotentan and Dapagliflozin or Dapagliflozin alone. Some participants may receive a placebo. The study will last for about 24 months, during which time participants will take the medication orally, in the form of a film-coated tablet. Throughout the study, participants will have regular check-ups to monitor their kidney function and overall health. The main focus will be on changes in kidney function over time, as well as other health indicators related to kidney disease.

This study aims to provide valuable information on whether the combination of Zibotentan and Dapagliflozin can offer better protection for the kidneys in people with Chronic Kidney Disease and High Proteinuria. By participating, individuals will contribute to research that could lead to improved treatments for this condition in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

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

    A blood test is performed to ensure kidney function is within the required range for participation.

  2. Step 2

    Medication administration

    Participants receive either a combination of zibotentan and dapagliflozin or dapagliflozin alone. Both medications are provided in the form of film-coated tablets.

    The tablets are taken orally once daily. The exact dosage is determined by the study protocol.

  3. Step 3

    Regular monitoring

    Participants attend regular visits to monitor kidney function and overall health. These visits occur from Day 15 up to Month 24.

    During these visits, blood pressure and protein levels in urine are measured to assess the effectiveness of the treatment.

  4. Step 4

    Primary evaluation

    The primary evaluation focuses on the change in kidney function, specifically the estimated glomerular filtration rate (eGFR), from the start of the study to Month 24.

  5. Step 5

    Secondary evaluation

    Secondary evaluations include changes in urine protein levels and blood pressure, as well as the time to any significant decline in kidney function.

    The proportion of participants achieving a significant reduction in urine protein levels is also assessed.

  6. Step 6

    Completion

    The study is estimated to conclude by July 2027. Participants will have a final assessment to evaluate the long-term effects of the treatment.

Who can join the trial?

9 criteria

  • Participants must be at least 18 years old and legally able to give consent in the area where the study is conducted.
  • Participants must have a diagnosis of Chronic Kidney Disease (CKD), with a specific range of kidney function measured by eGFR (a test that shows how well the kidneys are working) between 20 and 90 mL/min/1.73 m², and high levels of protein in the urine, measured by UACR or UPCR (tests that measure protein in urine).
  • All female participants must have a negative pregnancy test at the start of the study, unless they meet certain criteria for not being able to have children.
  • Female participants must either not be able to have children or, if they can, they must use a highly effective birth control method for at least 3 months before starting the study treatment.
  • Participants must be able to give signed informed consent, which means they understand the study and agree to take part.
  • Participants must provide signed informed consent before any study-specific procedures begin.
  • Participants must provide electronic informed consent before completing an optional feedback questionnaire about the study.
  • Participants must provide signed and dated consent for optional genetic research, which involves collecting samples for a genomics initiative.
  • Participants must be receiving RAASi therapy (a type of medication for kidney and heart conditions, such as ACEi or ARB) at the highest dose they can tolerate, and this treatment must have been stable for at least 4 weeks.

Who cannot join the trial?

10 criteria

  • Patients with severe liver disease cannot participate. This means if your liver is not working well, you may not be eligible.
  • Patients with a history of severe heart problems, such as heart attacks or heart failure, are excluded. Heart failure is when the heart doesn't pump blood as well as it should.
  • Patients who have had a stroke in the past 6 months cannot join. A stroke happens when blood flow to a part of the brain is stopped.
  • Patients with uncontrolled high blood pressure are not eligible. This means if your blood pressure is very high and not managed by medication, you cannot participate.
  • Patients with a history of cancer in the past 5 years, except for some skin cancers, are excluded. Skin cancer is a type of cancer that begins in the skin cells.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of the mother and baby.
  • Patients with a known allergy to the study drugs or similar drugs are excluded. An allergy is when your body reacts badly to something.
  • Patients who are currently participating in another clinical trial are not eligible. This is to avoid any interference with the study results.
  • Patients with a history of drug or alcohol abuse in the past year cannot join. Abuse means using too much of a substance in a way that is harmful.
  • Patients with certain infections, like HIV or hepatitis, are excluded. These are infections that affect the immune system and liver.
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Investigated drugs

  • Zibotentan

    is a medication being studied for its potential to help slow down the decline in kidney function. It is being tested in combination with another drug to see if it can provide additional benefits for people with chronic kidney disease and high levels of protein in their urine.

  • Dapagliflozin

    is a medication commonly used to treat certain conditions like diabetes by helping the kidneys remove sugar from the body through urine. In this study, it is being used to see if it can help protect kidney function in people with chronic kidney disease. The study is comparing the effects of using dapagliflozin alone versus using it in combination with another medication.

What is already known about the treatment

  • Zibotentan

    This medication is administered orally and is currently being studied in clinical trials for its potential benefits in treating chronic kidney disease with high proteinuria. It is not yet widely used in standard medical practice, as research is ongoing to establish its efficacy and safety. Zibotentan is primarily indicated for its potential to slow the decline in kidney function. It works by blocking the action of endothelin, a molecule that can constrict blood vessels and contribute to kidney damage. Zibotentan is classified as an endothelin receptor antagonist.

  • Dapagliflozin

    This medication is taken orally and is already approved for use in managing chronic kidney disease, among other conditions. It is being further evaluated in combination with zibotentan to assess its effectiveness in slowing kidney function decline. Dapagliflozin is indicated for reducing proteinuria and improving kidney outcomes. It functions by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which helps to lower blood sugar levels and reduce kidney stress. Dapagliflozin belongs to the class of SGLT2 inhibitors.

Investigated diseases

Chronic Kidney Disease – This condition involves a gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns may occur. High blood pressure and proteinuria, which is the presence of excess protein in the urine, are common complications. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function, while others may have a more rapid deterioration. Regular monitoring of kidney function is essential to understand the progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504124-26-00Protocol codeD4325C00010Estimated enrolment1 833 patientsSponsorAstraZeneca AB

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