Arvada

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.

Researchers are conducting a phase 3 randomized, double-masked study to compare the effectiveness of EYP-1901 with Aflibercept in people with diabetic macular edema (DME). The study focuses on patients who have either been treated before or are new to treatment for macular edema related to diabetic retinopathy. The goal is to evaluate how well these treatments improve vision in affected eyes over time. Participants will receive either EYP-1901 or Aflibercept through injections into the eye. Both treatments are given as intravitreal injections, meaning they are injected directly into the eye. The study design ensures that neither the participants nor the researchers know which treatment each participant receives, maintaining a double-masked approach to reduce bias. During the study, researchers will monitor changes in the participants' best-corrected visual acuity (BCVA) at weeks 52 and 56 to assess treatment effects. Participants' vision will be carefully measured using standardized eye charts. The total duration and detailed schedule of visits and assessments are guided by the study protocol to ensure thorough evaluation of each treatment's impact on diabetic macular edema.

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.

Researchers are evaluating the efficacy, safety, and tolerability of povetacicept in adults with primary membranous nephropathy (pMN), a kidney condition confirmed by biopsy. This study is a Phase 2b/3 adaptive, randomized, active-controlled trial comparing povetacicept with a calcineurin inhibitor treatment. Participants will receive either povetacicept, given as a solution for subcutaneous injection, or tacrolimus capsules taken orally. The study aims to compare these treatments in managing pMN over the course of the trial. Throughout the study, researchers will monitor participants for the proportion who achieve complete clinical remission by Week 104. Safety, tolerability, and other clinical outcomes will also be assessed to understand the treatments' effects over time.

Researchers are evaluating the blood pressure-lowering effect of an investigational drug called tonlamarsen in adults who were recently discharged from the hospital following treatment for acute severe hypertension. The study focuses on how well tonlamarsen reduces the protein angiotensinogen (AGT) in the blood, which plays an important role in blood pressure regulation, compared to a placebo. This is a Phase 2b, randomized, double-blind, placebo-controlled study designed to assess both the effectiveness and safety of tonlamarsen. Participants will receive monthly injections of either tonlamarsen or a placebo under the skin for about three months during the randomized portion of the study. The dosing occurs every four weeks, and the study is conducted across multiple centers. The goal is to observe changes in blood pressure and AGT levels while monitoring safety and tolerability. During the study, participants will visit the clinic around six times for initial evaluation, follow-up checkups, blood pressure measurements, blood tests, and other safety assessments. Researchers will measure the effect of tonlamarsen on plasma AGT levels and systolic blood pressure by week 12. Safety will also be closely monitored throughout the study to ensure participant well-being.

Researchers are studying pregnant women who receive general anesthesia during cesarean delivery to understand the reasons for its use, methods of airway management, and the outcomes related to obstetric and anesthetic care. This registry study collects data from multiple hospitals participating in the Society for Obstetric Anesthesia and Perinatology (SOAP) network over approximately five years. The study aims to identify hospital factors linked to anesthesia rates, describe anesthesia case details, and find predictors of difficult intubation. Data are gathered from 25 to 40 SOAP institutions and include information about each hospital's characteristics, such as maternal care level, birth numbers, and staff models. This institutional data is collected both before patient enrollment and at the end of the registry to observe changes over time. Pregnant women aged 15 to 55 who had general anesthesia for cesarean delivery are included, with detailed demographic, birth, gestational, maternal health, and anesthesia management data recorded anonymously. Participants' data entry is performed by the anesthesiologist shortly after care to ensure detailed, accurate information. Researchers will monitor rates of general anesthesia use and analyze factors like hospital type, staffing, and policies over up to five years. The study expects to enroll about 5,000 patients, with data maintained indefinitely in a secure, deidentified registry to improve understanding and care related to general anesthesia in cesarean deliveries.