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

3 1 1 1

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

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland
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Centre Hospitalier Universitaire Rouen Rouen France
Karolinska University Hospital Solna Sweden
Centre Hospitalier Universitaire De Nice Nice France
Amphia Hospital Breda The Netherlands
Areteus s.r.o. Trebisov Slovakia
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Klinik Hietzing Vienna Austria
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o. Poznan Poland
Medical Center Viva Phoenix OOD Dobrich Bulgaria
Uxhbgpezkitpoczmbkpie Nlnecsmszu Hw Tromsø Norway
Rizcye Svzvwgoky Holbæk Denmark
Awyaqpnt Uzuiyqfpbp Hucqmfzc Lorenskog Norway
Uxrprzi Unniwjyrzw Hpmvpiru Uppsala Sweden
Cxjdror Unhsyhsuzdqlgaftozuf Bzgxjl Klw Berlin Germany
Cssmmw Hokhoxrsidk Rthcfnfv Usfyqzswdzpks De Tvefd Tours France
Ibzza Owhzbont Polriwdyzgx Slc Mybxyer Genoa Italy
Agzjfbi Owkallexatg Uufmdfqjakshs Cbqstxssohkq Dcqic Suvlhz E Drvwu Srceqhv Dt Tilfsl Turin Italy
Ahbtoip Uqlareueni Hfatqgdk Aalborg Denmark
Acobirz Oflcafwitzk Ueokaqrqjqnrh Orngpphc Rxxprsq Foggia Italy
Ktccfqdp dlz Usamwnkfdqzv Mvxxdtud Ajt Munich Germany
Rwzlyl Mvdcsmtejca Aarhus Denmark
Iw Dqa sppegd Lučenec Slovakia
Abkirnl Uzpqz Shjlwrkgc Lvwtik Dj Brhzfme Bologna Italy
Asdxyvg Odfforwujbb Pkwl Ghyemltv Xmopt Bergamo Italy
Cghfmy Hjozzvoxxjv Ulogohfnxkmkd Dd Nqzae Nimes France
Uorktpawvx Dypjs Shbcs Dz Rojl Lu Szjgtgfu Rome Italy
Uezknnvqvtfvdqwrtuscb Aynloa Afh Aachen Germany
Hfbioztt Uigtoxdkgsmgu Pqqruw Dv Hjrtjk Dg Mllzfvblblp Majadahonda Spain
Hjaizrwc Utfxxpkkxnvtw 1v De Oklzzrc Madrid Spain
Hfnwv Snjldjhws Hn Stavanger Norway
Qbbxh Swkzkf Cbokortmi Hgvsgcny &yratrw Sakpzlihpcj Uedrkjjqwf Hsyqlnfu &yacfoy Vvkbyui Gbojcseqhkzryurmck Gothenburg Sweden
Hxoltvyp Uwopeqjigqymtv Srqsihyfpv &zxninf Hcovqno do Hkslggupjkw STRASBOURG, Alsace France
Ahgphrq Obnnbfsphvi Ubxxkdmtcuifu Prhrrs Pisa Italy
Cvfeaur Mkcqeqnm Djmxekvxo Radom Poland
Dcsydyxs suvzhd Presov Slovakia
Barxegk spmoj savnvk Puchov Slovakia
Intnykbq db Cmrgxmdegntr Hovyihmhyib Uetefnheifxwj dy Sqrkb Ejumxjf (spaelsc Saint Priest En Jarez France
Mlgupwa Czxklz Elljqm Mdxtqu Ohm Pleven Bulgaria
Srewvvtxyqovts Dka Fakghtcd Ggj Dresden Germany
Sbpqp Dkrpfywq Cwxuoi Gentofte Denmark
Uldraxzqdvgrk Sudzzmv Kvmhplkir Ny 2 Ppp W Srfqjksklw Szczecin Poland
Lhzaxc sopvny Lučenec Slovakia
Vvbdvkynxnkv Kfcjlyqmqxxppcsorqpdgboaoorymwdy mzn Feldkirch Austria
Alpbwk Ucfccagnbh Hthscdni Aarhus Denmark
Mwzwgku Mipbtkp Cmtqau Amersfoort The Netherlands
Abapzscs Htrvw Oa Pmgabg Swpk Kedzierzyn-Kozle Poland
Gvqjcg Hqtrowroxyh Da Lg Rggyfz De Mwlnbdio Ed Sii Ajslge Mulhouse France
Cthiwjk Mnxtkmlj Mubsy Slx z ovac Rzeszow Poland
Rruvyu Opdqpbjamamezw Linkoping Sweden
Aigpfv Sljcgptzld Zkykyrfnpp Dordrecht The Netherlands
Uxxwinaipb Megebekvexzf Hdqifqdg Fol Aoleuz Tslaophzj Kuclkxl Ejfo Plovdiv Bulgaria
Uschd &vngdut Ppolf Dtg Smryim Kbyobszww Ak Stara Zagora Bulgaria
Nbvtbhbpdyqbcvcggw Ho Bodo Norway
Kzmziqa Mtkcilz Clvcbi Lubj Sofia Bulgaria
Tupetmehau stetnj Roznava Slovakia

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.

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

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