Dakota Dunes

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating ADX-038, an investigational siRNA duplex oligonucleotide drug, in adults with complement-mediated kidney diseases such as IgA nephropathy IgAN, C3 glomerulopathy C3G, and immune complex-mediated membranoproliferative glomerulonephritis IC-MPGN. This Phase 2 study aims to assess the safety, effectiveness, and how the drug behaves in the body pharmacokinetics and pharmacodynamics. Participants will receive one of two dose levels of ADX-038. The study includes groups with different kidney disease types receiving different doses. The treatment is given as part of a parallel, non-randomized study design. Vaccinations may be required as part of the protocol. During the study, participants undergo monitoring for safety and tolerability over a period of up to 36 months. Researchers will evaluate kidney function and disease activity, and participants will be closely observed for any side effects. The study will last until June 2029, with the primary completion expected by the end of 2028.

This research aims to evaluate the effectiveness and safety of LUPKYNIS combined with belimumab, obinutuzumab, or anifrolumab in adults with lupus nephritis LN. The study focuses on how well these combinations induce a rapid kidney response in patients diagnosed with LN, a condition affecting kidney health. It is a phase 4 clinical trial sponsored by Aurinia Pharmaceuticals Inc. that assesses treatment approaches for this condition. Participants will receive LUPKYNIS along with one of the biologic agents belimumab, obinutuzumab, or anifrolumab. In addition, all patients will be treated with a mycophenolic acid analog MPAA, such as mycophenolate mofetil or mycophenolic acid, and corticosteroids like prednisone or an equivalent. The biologic treatment schedules vary depending on the specific drug, with some patients already receiving treatment before the study starts or beginning it at the start of the trial. During the study, participants will be monitored for kidney response over 24 weeks, including complete and partial renal responses. Researchers will assess safety by tracking treatment-emergent adverse events up to 28 weeks. Other assessments include measuring changes in kidney-related antibodies and complement levels at baseline, 12 weeks, and 24 weeks. The total participation duration extends to about 28 weeks, during which various evaluations, laboratory tests, and safety monitoring will occur to understand treatment effects and patient outcomes.

Researchers are evaluating the safety and tolerability of BHV-1400 as a treatment for people with IgA Nephropathy, a kidney condition confirmed by biopsy. This Phase 1 study aims to observe how participants respond to BHV-1400, an investigational drug administered under medical supervision. Participants will receive BHV-1400 through subcutaneous injections. This open-label study involves a single group receiving the study drug without a placebo comparison. The treatment period and dosing schedule are designed to monitor safety outcomes over a year. During the study, participants will be closely monitored for serious adverse events, adverse events leading to discontinuation, and deaths, along with laboratory abnormalities of grade 3 or 4 severity. The study lasts up to one year and includes regular evaluations to ensure participant safety and gather detailed safety data.

Researchers are studying the safety, effectiveness, and how the body processes the investigational drug WAL0921 in adults with various glomerular kidney diseases and proteinuria. These include diabetic nephropathy and rare conditions such as primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers to evaluate WAL0921 compared to a placebo. Participants will be randomly assigned to receive either the investigational drug WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. The study includes a treatment period followed by a 24-week follow-up after the last infusion to monitor participants. The treatments are given in parallel groups to compare their effects and safety. During the study, participants will undergo regular assessments including monitoring for adverse events from the start through Week 36. Researchers will also measure changes in albuminuria, proteinuria, and kidney function markers such as estimated glomerular filtration rate over 24 weeks. These evaluations help determine how the drug affects kidney disease markers and overall safety. The total participation time includes treatment and follow-up periods lasting several months.

Researchers are conducting a phase 2b open-label trial to study immunoglobulin A nephropathy IgAN, a kidney disease. The study aims to identify tissue biomarkers of the disease and observe potential changes in response to the drug sibeprenlimab. This research is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. and focuses on adolescents and adults with IgAN confirmed by kidney biopsy. Participants will receive sibeprenlimab through subcutaneous injections during the study. The trial includes repeat kidney biopsies to evaluate histopathology changes in the kidney tissue. The main focus is to assess changes in glomerular IgA deposition by immunofluorescence from the start of the study to week 52. During the participation, individuals will undergo kidney biopsies and monitoring of kidney function, including estimated glomerular filtration rate eGFR. Researchers will also monitor safety and any changes in kidney tissue over the yearlong study period. The total duration of participation includes screening and treatment up to 52 weeks with follow-up evaluations.