| Trial ID: | L0063 |
| Source ID: | NCT05570305
|
| Associated Drug: |
Zibotentan
|
| Title: |
Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria
|
| Acronym: |
ZODIAC
|
| Status: |
ENROLLING_BY_INVITATION
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases
|
| Interventions: |
DRUG: Zibotentan|DRUG: Dapagliflozin|DRUG: Placebo|DRUG: Dapagliflozin and Zibotentan
|
| Outcome Measures: |
Primary: Change from baseline in albuminuria after 4 weeks combined zibotentan and dapagliflozin treatment versus four weeks treatment with zibotentan alone., The change in albuminuria as expressed the percentage change of the log-transformed albumin:creatinine ratio in mg/gram. The log-transformation is because of the skewed distribution., 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. | Secondary: Change in Extracellular Fluid, Extracellular Fluid measured by bioimpedance spectroscopy, 4 weeks|Change in bodyweight, Change in kilograms, 4 weeks|Change in NT-proBNP, N-terminal B-type natriuretic peptide (NT-proBNP), 4 weeks|Change in BNP, B-type natriuretic peptide (BNP), 4 weeks|Change in Glomerular Filtration Rate (GFR), Glomerular Filtration Rate (GFR) using iohexol clearance techniques., 4 weeks|Change in Extracellular volume (ECV), Extracellular volume (ECV) using iohexol clearance techniques., 4 weeks|Change in hematocrit, The percentage of red blood cells in blood, 4 weeks|Change in systolic and diastolic blood pressure, Change in blood pressure as measure in mmHg, 4 weeks | Other: Change in renin-angiotensin-aldosterone system (RAAS) markers, Change in RAAS markers in plasma and urine, 4 weeks|Change in copeptin, Change in copeptin as a surrogate of vasopressin, 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: University Medical Center Groningen | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
38
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-10-06
|
| Completion Date: |
2024-09-01
|
| Results First Posted: |
|
| Last Update Posted: |
2023-09-29
|
| Locations: |
Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Toronto General Hospital, Toronto, Ontario, M5G 2N2, Canada|Montreal Clinical Research Institute, Montreal, Quebec, H2W 1R7, Canada|Steno Diabetes Center, Copenhagen, Gentoft, DK-2820, Denmark|Amsterdam Universitair Academisch Centrum, Amsterdam, Noord Holland, 1081 HV, Netherlands|University Medical Center Groningen, Groningen, Netherlands|Center for Cardiovascular Science, Edinburgh, EH16 4TJ, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT05570305
|
