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 range18 Years – 75 Years
SexALL
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…
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.