New drug cocktail aims to protect kidneys in High-Risk patients
NCT ID NCT06942910
First seen Jun 24, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This Phase 2 study tests whether a combination of two drugs, zibotentan and dapagliflozin, works better than dapagliflozin alone at reducing protein leakage in urine for adults with chronic kidney disease. About 224 participants will receive either the combo or the single drug. The main goal is to see if the combo lowers protein levels more effectively, which could mean better kidney protection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Zibotentan and Dapagliflozin combination
- What this could lead to
- If successful, this could offer a new treatment option to slow kidney damage in people with chronic kidney disease and high protein levels in urine.
- What could go wrong
- This is an early Phase 2 trial with only 224 participants, so results may not apply to everyone. The combination may cause side effects or not work better than the existing drug alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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224 people
The number who actually took part.
- Started
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May 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥ 18 years of age at the time of signing the informed consent. * Diagnosis of CKD with eGFR ≥ 20 and \< 90 mL/min/1.73m2 AND UACR \> 700 mg/g (\> 79 mg/mmol) or UPCR \> 1000 mg/g (\> 113 mg/mmol). * Body mass index (BMI) within the range ≤40 kg/m2. * Female participants must be either - not of child-bearing potential or - women of childbearing potential (WOCBP) using at least one highly effective birth control method for at least 3 months prior to first dose of study intervention. * All WOCBP must have a negative serum pregnancy test result at screening. * Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks. Exclusion Criteria: * Clinically significant, unstable, or uncontrolled medical condition which in the Investigator's opinion makes it undesirable for the participant to participate in the study. * Known hypersensitivity to dapagliflozin or zibotentan or any of the excipients of the investigational product. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i therapy or ERAs. * NYHA class III or class IV HF. * Participants hospitalised for HF and/or who have not been stable on HF therapy during the last 6 months prior to screening. * HF due to cardiomyopathies that would primarily require other specific treatment. * High output HF (eg, due to hyperthyroidism or Paget's disease). * HF due to primary cardiac valvular disease/dysfunction, severe functional mitral or tricuspid valve insufficiency, or planned cardiac valve repair/replacement. * Evidence of rales or jugular venous distention on physical examination. * Type 1 diabetes mellitus. * History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal). * Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening. * History of solid organ transplantation or bone marrow transplant. * Any condition with a life expectancy of less than 1 year based on investigator´s clinical judgment. * Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma skin cancer and curatively treated cervical carcinoma in situ. * Significant liver disease as judged by the investigator. * Renal replacement therapy or previous kidney transplant. * Known history of significant drug or alcohol abuse within 12 months of screening. * On treatment with strong or moderate CYP3A4 inducer. * On systemic immunosuppression therapy other than prespecified stable maintenance therapy. * Participants treated or expecting to be treated with tolvaptan (including as part of participation in a clinical trial), any other ERAs, or budesonide (where used to treat IBD or IgAN). * Systolic blood pressure above 160 mmHg and/or below 90 mmHg. * Significant impairment of liver function defined as AST or ALT \>3 x upper limit of normal (ULN) or Total serum bilirubin \>2 x ULN (an isolated increase in bilirubin in participants with known Gilbert's syndrome is not a reason for exclusion). * NT-proBNP ≥ 600 pg/mL (or NT-proBNP ≥ 1200 pg/mL, if associated with atrial fibrillation) measured by local laboratory at screening. * Any of the following results of echocardiography at screening: * left ventricular ejection fraction (LVEF) \< 50% * significant ventricular wall motion abnormality or severe cardiac valve abnormalities * isolated pulmonary arterial hypertension (as defined by local clinical practice) or right ventricular failure; in the absence of left-sided HF * Women who are pregnant, breast-feeding, or women with intent of getting pregnant. * Women who are not willing to use adequate contraception or cannot, in the opinion of the Investigator, understand and/or comply with the study requirements regarding contraception.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Aramil, 624002, Russia
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Research Site
Izhevsk, 426061, Russia
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Research Site
Krasnoyarsk, 660062, Russia
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Research Site
Moscow, 111539, Russia
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Research Site
Moscow, 117036, Russia
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Research Site
Moscow, 129327, Russia
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Research Site
Omsk, 644112, Russia
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Research Site
Orenburg, 460018, Russia
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Research Site
Perm, 614000, Russia
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Research Site
Saint Petersburg, 195067, Russia
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Research Site
Saratov, 410053, Russia
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Research Site
Saratov, 410054, Russia
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Research Site
Ulyanovsk, 432009, Russia
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Research Site
Yaroslavl, 150062, Russia
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