Proteinuria

Researchers are studying pregnant women to understand how microbiome, proteomics, and serum markers might help predict preeclampsia, a condition that can affect pregnancy. This multicenter, prospective cohort study also aims to explore how these biological markers relate to pregnancy outcomes such as complications during pregnancy, delivery, and the newborns health. The study is conducted by Zhujiang Hospital and focuses on maternal and infant microecology in China. Pregnant women who come to the hospital before 14 weeks of gestation are invited to participate. After consenting, they will complete a questionnaire and provide samples including urine, serum, saliva, vaginal swabs, and feces at several points during pregnancy 11-14 weeks, 22-28 weeks, 32-34 weeks, and at delivery. If possible, placenta, cord blood, and amniotic fluid will also be collected at delivery. Women with preeclampsia during pregnancy will be followed up with similar sampling up to two years after their child is born. Participants will be monitored through various laboratory assessments including 16S rRNA gene sequencing for microbiome analysis and advanced techniques like MALDI-TOF peptidomics and mass spectrometry metabonomics. The study will also evaluate patient-specific risk of preeclampsia using clinical measurements such as mean arterial pressure and serum placental growth factor. Follow-up visits after delivery will occur at 6 weeks, 6 months, 1 year, and 2 years to continue monitoring maternal and infant health. The primary outcomes include microbiome, proteomics, and metabonomics data collected over 34 months, with secondary outcomes assessed over 10 months.

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 the use of dapagliflozin to reduce cardiovascular risk in women who have experienced hypertensive pregnancies. This randomized, placebo-controlled trial focuses on patients at high risk for adverse cardiovascular outcomes within five years after delivery. The study is a pilot-scale, single institution investigation aiming to assess the feasibility, acceptability, and effects of dapagliflozin during the postpartum period. Participants will be randomly assigned to one of two groups one group will receive dapagliflozin 10 mg daily for six months, while the other group will receive a daily placebo for the same duration. During the study, participants will attend four study visits and complete specific activities including daily blood pressure monitoring, weekly weight measurements, laboratory tests, and echocardiograms. After the six-month treatment period, participants will be followed remotely for one month. Throughout the trial, researchers will measure cardiovascular risk reduction scores at the start and after six months of treatment. Secondary outcomes include tracking patient adherence, barriers to adherence, loss to follow-up rates, and screening statistics over a two-year recruitment period. The total participation includes treatment and follow-up visits, with regular assessments to monitor health and gather data for evaluating the study drugs impact on cardiovascular risk.

Researchers are evaluating whether using a digital smartphone application can help adults with chronic kidney disease CKD better follow the 2024 Kidney Disease Improving Global Outcomes KDIGO guidelines. The study focuses especially on young adults transitioning from pediatric to adult nephrology care, who face higher risks and challenges during this vulnerable period. The research aims to improve treatment adherence and health outcomes by addressing gaps in current care and guideline implementation. Participants will use a modified version of the St. Jamess Hospital Renal App, which has been adapted to align with the KDIGO 2024 guidelines. The app provides tailored recommendations, reminders, educational materials, and collects patient-reported outcomes. The study uses a randomized stepped wedge design where patients receive first exposure and later continued use of the app. The intervention supports healthcare providers by highlighting opportunities for evidence-based therapies and helps patients manage their care digitally. During the study, participants will be monitored for changes in adherence to KDIGO guidelines over 18 months. Assessments will include patient engagement, clinical data integration via electronic health records, and patient-reported measures. The app also supports appointment management and medication reminders, aiming to enhance self-management and slow CKD progression. The research includes diverse patient subgroups and considers cultural and linguistic needs to promote equitable care.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of AP1189 in patients with idiopathic membranous nephropathy iMN who have severe proteinuria. This exploratory, randomized, double-blind, placebo-controlled study focuses on patients already receiving ACE inhibitor or angiotensin II receptor blocker treatment, aiming to understand how AP1189 affects these patients over a 12-week period. Participants will be randomly assigned in a 21 ratio to receive either 100 mg of AP1189 or a matching placebo daily for 12 weeks, alongside their ongoing treatments. The study is conducted at multiple centers and maintains a triple-blind design to ensure unbiased results. The AP1189 and placebo are administered as tablets taken once each day during the treatment period. During the study, participants will undergo regular monitoring including assessments of adverse events, blood tests for liver enzymes and bilirubin, and measurements of protein levels in urine over 24 hours. Researchers will also track albumin levels in urine. These evaluations occur up to week 12, covering safety and treatment effects. The studys total duration includes screening, 12 weeks of treatment, and follow-up to capture all relevant data on patient health and response to the investigational drug.

Researchers are studying hospitalized women with preterm preeclampsia to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug called CBP-4888. This open-label dose-finding study focuses on pregnant participants between 26 and nearly 36 weeks gestation who are receiving standard care with expectant management. The study aims to find the appropriate dose and monitor outcomes for both mothers and their babies. During the study, eligible participants will receive a single subcutaneous injection of CBP-4888 on Day 1, with dosing based on the participants first trimester weight. Up to 60 participants will be enrolled across six dose levels, with all receiving standard care alongside the study drug. Mothers will be closely monitored through delivery and for six weeks postpartum, while their infants will be followed for up to 24 months with regular pediatric assessments. Participants will be observed for treatment-related events and adverse effects through six weeks after delivery. Infants will undergo evaluations immediately after birth and continue with developmental assessments using the Ages and Stages Questionnaire up to two years of age. The study tracks drug levels in the blood, safety signals, and long-term developmental outcomes to understand the effects of CBP-4888 on both mothers and their children.

Researchers are studying children and young adults aged 1 to 18 years with chronic kidney disease CKD and proteinuria, a condition where the kidneys leak protein into the urine. This study aims to evaluate the long-term safety of finerenone when added to standard treatments called ACE inhibitors or angiotensin receptor blockers ARBs, which are commonly used to control blood pressure and protect kidney function. The research also seeks to understand how well finerenone can reduce protein levels in urine and support kidney health over time. Participants will receive finerenone in doses adjusted by age and body weight, taken orally for up to 18 months alongside their usual ACEI or ARB treatment. The study includes patients who previously took part in a related trial and will follow them for about 19 months, including a one-month follow-up after treatment ends. The research involves one group receiving finerenone openly without placebo or comparison groups. During the study, participants will attend at least 8 to 12 visits depending on their treatment start status. At these visits, doctors will measure vital signs like blood pressure, heart rate, weight, and height perform physical exams collect blood and urine samples to monitor kidney function and protein levels and conduct heart tests using electrocardiograms and echocardiography. Participants and their caregivers will also answer questions about medication use, side effects, and overall well-being. Safety will be closely monitored by tracking any medical problems that arise during the trial.

Researchers are investigating a new treatment approach for children with chronic kidney disease CKD and proteinuria, conditions that affect kidney function and cause protein leakage into the urine. The study focuses on whether adding a drug called finerenone to existing treatments with angiotensin-converting enzyme inhibitors ACEI or angiotensin receptor blockers ARB can better control kidney problems related to overactivity of a system that regulates blood pressure and fluid balance. This Phase 3 study aims to see if finerenone can reduce protein levels in the urine more effectively than a placebo. Participants in this trial will receive either finerenone or a placebo alongside their usual ACEI or ARB medication. The study treatment lasts about 180 days, with doses adjusted for age and body weight. Before starting treatment, children must pass screening visits to confirm eligibility. During treatment, participants will attend at least seven visits where various health checks, blood and urine tests, heart exams, and questionnaires about medication experience and side effects will be performed. Throughout the study, researchers will monitor kidney function, electrolyte levels, and how the body processes finerenone. They will also track any medical problems participants experience. After completing treatment, participants will have a follow-up visit about 30 days later to assess their health. The main measure of success is the change in the urinary protein-to-creatinine ratio from before treatment to about six months later, helping to understand the treatments impact on proteinuria.

Researchers are evaluating the safety and effectiveness of ACE Reno, an oral transmucosal solution containing standardized bioactive peptides and amino acids, in patients with nephropathy caused by various conditions like diabetes, hypertension, autoimmune diseases, and chronic kidney disease CKD stages 1 to 5. The trial aims to determine if 12 weeks of ACE Reno treatment can reduce albuminuria or proteinuria and stabilize kidney function in these patients. Nephropathy is a significant global health issue affecting millions and leading to high socioeconomic costs worldwide. Participants will receive ACE Reno as a sublingual solution at a dose of 1 mL four times daily for 12 weeks. The solution contains peptide components designed to target pathways involved in kidney damage, including antifibrotic and vasodilatory mechanisms. This is an open-label, single-arm study with assessments at screening, baseline, weeks 4, 8, and 12, followed by a safety follow-up call at week 16. During the study, participants will undergo clinical evaluations including blood pressure, vital signs, weight, and laboratory tests such as creatinine, estimated glomerular filtration rate eGFR, electrolytes, liver panel, complete blood count, and urine albumin-to-creatinine ratio ACR. Patient-reported outcomes on fatigue and quality of life will also be collected. The primary outcome is the change in urinary ACR after 12 weeks. Safety and tolerability will be monitored throughout treatment and during the 4-week post-treatment follow-up period.

Researchers are investigating how algae supplements may affect markers of cardiovascular risk and the gut microbiome in adults aged 50 and older who have certain cardiovascular or metabolic conditions. The study focuses on the impact of Spirulina Arthrospira platensis a microalgae and Gelidium corneum a macroalgae on blood lipid levels, blood pressure, inflammation, and microbiota composition. The microbiome, often called the second genome, influences heart and vascular health through metabolites like trimethylamine-N-oxide and short-chain fatty acids. Participants will be randomly assigned to one of three groups to receive either Spirulina Arthrospira platensis, Gelidium corneum, or a placebo. Each supplement is taken as four capsules daily, split into two doses with two capsules in the morning and two in the evening, for 20 weeks. The study includes three clinical evaluations two before starting supplementation and one after the 20-week intervention period. During the study, participants will undergo assessments of vascular health, nutrition, and physical activity, along with collections of blood, urine, saliva, and stool samples. These will be analyzed for biomarkers such as plasma trimethylamine-N-oxide and short-chain fatty acids, oral and gut microbiota, blood pressure, cholesterol levels, inflammatory markers, and kidney function. The study aims to measure changes in these factors over time to understand the potential benefits of algae supplementation on cardiovascular health.