Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria (NCT05570305) | Clinical Trial Compass
CompletedPhase 2
Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria
United States, Canada, Denmark42 participantsStarted 2022-10-06
Plain-language summary
The aim of this study is to test the hypothesis that the effects on albuminuria of combination treatment with the endothelin receptor antagonist zibotentan and SGLT2i dapagliflozin are complimentary and additive while the fluid retaining effects of zibotentan can be mitigated by dapagliflozin.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 and ≤75 years
* Urinary albumin:creatinine ratio \> 100 mg/g and ≤ 3500 mg/g in a first morning void urine collection
* eGFR ≥ 30 mL/min/1.73m2
* On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization
* Willing to sign informed consent
Exclusion Criteria:
* Diagnosis of type 1 diabetes
* Minimal change disease, unstable rapidly progressing renal disease, and/or renal disease requiring significant immunosuppression, autosomal dominant or autosomal recessive polycystic kidney disease
* Hba1c \> 12.5%
* Urinary protein excretion \> 3500 mg/day
* Heart Failure NYHA Class III or IV
* NT-proBNP \> 600 pg/ml
* Hemoglobin \<9g/dL
* Acute coronary syndrome event within the preceding 6 months
* Severe peripheral edema according to investigators opinion
* Women of childbearing potential (WOCBP). WOCBP is defined as women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal
* Pregnancy or breastfeeding
* Indication for immunosuppressants according to Investigator's opinion
* Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin within the last 5 years.
* Use of the co-interventional treatments (outlined in section 5.2) within 6 weeks of screening.
* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in albuminuria after 4 weeks combined zibotentan and dapagliflozin treatment versus four weeks treatment with zibotentan alone.
Timeframe: The albuminuria will be measured before start of medication intake and after the last intake of medication for each treatment period. This concerns a 4 week time frame.