College Park

This trial investigates MZE829 capsules in adults with proteinuric chronic kidney disease who also carry the APOL1 high risk genotype, specifically G1G1, G2G2, or G1G2 variants. The study aims to evaluate the safety, tolerability, and impact on albuminuria, a marker of kidney damage, in this population. It is an open-label Phase 2 trial, meaning all participants receive the study drug and results will help determine its effects and safety profile. Participants receive MZE829 capsules orally in a single-group design. The study includes two cohorts one with chronic kidney disease alongside diabetes, and another with chronic kidney disease without diabetes. The treatment and monitoring occur over a 12-week period, during which the study team assesses drug safety and effects on albuminuria levels. During the trial, participants will be monitored for adverse events and tolerability from baseline through week 12. Researchers will also measure changes in urine albumin-to-creatinine ratio UACR to evaluate kidney function. Blood samples will be taken to assess plasma drug concentrations. The total participation time is approximately 12 weeks, focusing on safety and biological effects of MZE829.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 who have APOL1-mediated proteinuric kidney disease. This study includes participants with specific APOL1 genotypes and aims to understand how VX-147 affects kidney function over time in this population. Participants are randomly assigned to receive different doses of VX-147 or a matching placebo. Those in the initial phase Part A will receive their assigned treatment for at least 96 weeks. Participants who complete Part A will then receive VX-147 for an additional 96 weeks in Part B. The study uses tablets taken orally and includes a placebo control group. During the trial, participants will be monitored regularly for changes in urine protein to creatinine ratio and kidney function measured by estimated glomerular filtration rate eGFR. Safety and tolerability are assessed through tracking adverse events throughout the study, which may last around four years after the last participant enrolls. Blood levels of VX-147 will also be measured, and pediatric participants will be asked about their satisfaction with the tablet form.