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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Age: 18Years +All GendersPhase 3
759 locations
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Actively Recruiting

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 on kidney function in adults with chronic kidney disease, some of whom may also have type 2 diabetes, and who are living with overweight or obesity. The study compares NNC0519-0130 with semaglutide, an existing medicine, and a placebo, which is a "dummy" treatment. This is a Phase 2 proof-of-concept and dose-finding study aimed at understanding how these treatments may reduce kidney damage. Participants will be randomly assigned to one of three groups receiving either NNC0519-0130, semaglutide, or placebo. All treatments are given by subcutaneous injection once weekly. The study treatment phase lasts up to 36 weeks, with assessments at weeks 12, 24, and 36 to monitor changes in kidney damage by measuring the urinary albumin-to-creatinine ratio. The overall study duration can be up to 43 weeks. During the study, participants will be regularly monitored through laboratory tests and clinical evaluations to assess kidney function and safety. Researchers will measure changes from the start of the study in the urinary albumin-to-creatinine ratio at multiple time points. Participants will also need to have stable doses of certain blood pressure medications before joining. Safety and treatment effects will be assessed throughout the study period.

Age: 18Years +All GendersPhase 2
147 locations
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Actively Recruiting

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Age: 18Years +All GendersPhase 2Phase 3
542 locations
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