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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
Centre Hospitalier Universitaire Rouen Rouen France
Areteus s.r.o. Trebisov Slovakia
Studienzentrum Dr. Faulmann GbR Dresden Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Feldkirch Austria
IRCCS Ospedale Policlinico San Martino Genoa Italy
Aalborg University Hospital Aalborg Denmark
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Klinik Hietzing Vienna Austria
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o. Poznan Poland
Medical Center Viva Phoenix OOD Dobrich Bulgaria
Centre Hospitalier Universitaire De Nimes Nimes France
Region Oestergoetland Linkoping Sweden
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Amphia Hospital Breda The Netherlands
Helse Stavanger HF Stavanger Norway
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Nordlandssykehuset HF Bodo Norway
Kalimat Medical Center Ltd. Sofia Bulgaria
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Karolinska University Hospital Solna Sweden
Meander Medical Center Amersfoort The Netherlands
Centre Hospitalier Universitaire De Nice Nice France
Region Midtjylland Aarhus Denmark
American Heart Of Poland S.A. Kedzierzyn-Kozle Poland
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Region Sjaelland Holbæk Denmark
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Tatratrial s.r.o. Roznava Slovakia
Dibsmipo sswxkz Presov Slovakia
Bzenyge szyrf sacwzf Puchov Slovakia
Suezk Dzkflejd Cjvdfg Gentofte Denmark
Cpsjft Hcjwovnpzlk Rleqblny Ucexnhuoojdvu Dc Tlwcm Tours France
Aqgzhim Oaoqfpmrljs Ubhuqtudhurut Cwvtldddmblx Doiib Sfarzo E Dakpd Sakhcrd Dr Tvfvuy Turin Italy
Arcalrv Oxupcyixrve Ulilrfldqeuyi Oihyscux Rnqxuve Foggia Italy
Kcorhxco dyk Ueprdkubvghp Mrxkbnwe All Munich Germany
Avplnqy Odkmlnpxtev Ptyf Gfpcqctj Xevgb Bergamo Italy
Cirjjdd Muekamhx Dtufunpwc Radom Poland
Mhfnpyu Crmmzq Ehxejh Mtmfag Onp Pleven Bulgaria
Upmoryuvkuwpk Szdyugz Klquurrqk Nc 2 Pzs W Szcaqbwkyd Szczecin Poland
Lwnftm stdblt Lučenec Slovakia
Alnvtfpt Uyqzcqtakx Hxkdfrcw Lorenskog Norway
Amblgkf Uvyct Sybgpanuu Lwhpli Dl Bnvnqom Bologna Italy
Udxqqrfzik Dubfk Szbrr Dz Rmir Lt Szcauqdx Rome Italy
Utayarx Uyszoqlglh Hgsqkwtc Uppsala Sweden
Ajujou Uvxptfezfa Hedqgvkp Aarhus Denmark
Iagfpehy dh Cxkugykjtxce Hcbwlldublp Unrszigizmpxw da Shfod Eqhrcsp (uckrabg Saint Priest En Jarez France
Haxjkvfh Uqyfmadxqklabw Svbapfwxpr &sdwace Huaecpe dj Hexnwmvmwbz STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
10.11.2023
Bulgaria Bulgaria
Not recruiting
10.11.2023
Denmark Denmark
Not recruiting
10.11.2023
France France
Not recruiting
10.11.2023
Germany Germany
Not recruiting
10.11.2023
Italy Italy
Not recruiting
10.11.2023
Norway Norway
Not recruiting
10.11.2023
Poland Poland
Not recruiting
10.11.2023
Slovakia Slovakia
Not recruiting
10.11.2023
Spain Spain
Not recruiting
10.11.2023
Sweden Sweden
Not recruiting
10.11.2023
The Netherlands The Netherlands
Not recruiting
10.11.2023

Trial locations

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.

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 ID:
2023-504124-26-00
Protocol code:
D4325C00010
NCT ID:
NCT06087835
Trial Phase:
Therapeutic confirmatory (Phase III)

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