Dakota Dunes

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are evaluating ADX-038, an investigational siRNA 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 for these kidney conditions. The study is sponsored by ADARx Pharmaceuticals, Inc. The study involves administration of ADX-038 at two different dose levels as an experimental treatment. Participants receive one of these doses to evaluate their impact on kidney disease. The treatment is given alongside supportive care, including ACE inhibitors or ARBs when applicable. Participants must be willing to receive required vaccinations during the study. Participants will be monitored over 36 months to evaluate the safety and tolerability of ADX-038. The study includes regular assessments of kidney function and disease activity, with ongoing observation to track any side effects or changes in health. Researchers will measure how well the drug is tolerated and its effects on complement-mediated kidney disease during this period.

Researchers are evaluating the safety and effectiveness of up to two injections of REACT/rilparencel in adults with type 2 diabetes mellitus and chronic kidney disease. This phase 3, randomized, blinded study compares participants receiving two REACT/rilparencel injections to those undergoing sham procedures that simulate the biopsy and injection steps without actual treatment. The study aims to understand how this therapy might impact kidney function and disease progression. Participants are randomly assigned to one of two groups. The experimental group will receive a kidney biopsy followed by a rilparencel injection into the biopsied kidney, then about 12 weeks later, a second injection into the other kidney. The control group undergoes two sham procedures spaced approximately 12 weeks apart that mimic the real treatment steps but involve no actual biopsy or injection. All participants are followed until the study ends in 2029. During the study, participants will have kidney biopsies or sham procedures, followed by injections or sham injections. Researchers will monitor kidney function through measures like estimated glomerular filtration rate (eGFR) over up to 94 months. They will also assess clinical outcomes such as kidney failure events, death, and quality of life changes. Safety and efficacy are observed through regular visits and evaluations throughout the trial.

Researchers are evaluating BHV-1400 as a treatment for adults with IgA Nephropathy (IgAN), a kidney condition confirmed by biopsy. This Phase 1 study aims to assess the safety and tolerability of BHV-1400 in people diagnosed with this disease. The study is sponsored by Biohaven Therapeutics Ltd. and involves participants aged 18 to 65 years. Participants will receive BHV-1400, which is given as a subcutaneous injection under the skin. This is an open-label study, meaning both researchers and participants know the treatment being given. The focus is on monitoring for any serious adverse events, side effects leading to stopping the treatment, deaths, and significant laboratory changes during up to one year of follow-up. During the study, participants will be closely monitored for safety through regular assessments and laboratory tests. The main outcomes measured include the number of participants who experience serious side effects or severe lab abnormalities within one year. Participants can expect ongoing evaluations to track their health status while receiving the study treatment. The study is planned to run until July 2027.

Researchers are studying the safety, effects, and how the body processes the investigational drug WAL0921 in adults with glomerular kidney diseases that cause proteinuria. These diseases include diabetic nephropathy, primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This is a phase 2, multi-center, randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive either WAL0921 or a placebo through an intravenous infusion every two weeks, for a total of seven infusions. The study compares these two groups to assess the drug's safety and impact. After completing the infusions, all participants will be monitored for an additional 24 weeks. During the study, researchers will track adverse events from the start through week 36 to evaluate safety. They will also measure changes in albuminuria, proteinuria, and kidney function (including estimated glomerular filtration rate) from baseline up to week 24. Follow-up visits and monitoring ensure participants' health and collect data on how the drug affects their kidney disease over time.

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.