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 newborn's 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.

Preeclampsia (PE) is a serious condition affecting 3-8% of pregnancies and is a leading cause of illness and death for mothers and babies. It involves high blood pressure and organ damage or growth problems in the fetus. There are two main types: placental PE, linked to problems with the placenta and early pregnancy complications, and metabolic PE, related to maternal metabolic issues like obesity and inflammation. Recent research suggests that changes in the mother's gut bacteria may influence the immune system and play a role in PE development. This study aims to better understand the gut microbiota differences in these two PE types to improve prediction and prevention. The study observes pregnant women from 11 to 13 weeks gestation who are either at high risk or low risk for developing PE based on early screening. Participants include women over 18 with a single pregnancy and a live fetus. Researchers will monitor maternal gut microbiota, metabolic markers, and immune system characteristics during the first trimester without providing any treatments. The study includes a control group of low-risk pregnancies followed throughout pregnancy to compare with the high-risk group. Participants will undergo assessments including gut microbiota analysis, metabolic profiling, and immune function tests during early pregnancy. Researchers will track outcomes related to PE development and fetal growth restriction, aiming to identify biomarkers that could help predict PE types. The study lasts about one year per participant, with data collected during pregnancy and after delivery. This observational study does not involve treatment but focuses on collecting detailed biological and clinical information to improve understanding of PE.

Researchers are evaluating the safety, tolerability, and effect on albuminuria of the drug MZE829 in adults with proteinuric chronic kidney disease who carry the APOL1 high risk genotype. This open-label Phase 2 study focuses on participants with proteinuria and the specific genetic risk factors G1/G1, G2/G2, or G1/G2. The study aims to better understand how MZE829 impacts kidney disease in this targeted group. Participants will receive MZE829 capsules taken orally. The study includes two groups: one with chronic kidney disease and concurrent diabetes, and another with chronic kidney disease without diabetes. The treatment period lasts 12 weeks, during which safety and tolerability will be closely monitored along with the drug's effect on albuminuria. This design allows researchers to assess the drug’s impact across different patient profiles. During the study, participants will be monitored from Day 1 through Week 12 with regular assessments for adverse events and measurement of albuminuria reduction. Researchers will also track plasma drug concentrations to understand how the body processes MZE829. Safety and tolerability will be evaluated based on the incidence of any adverse events throughout the 12-week treatment period. The total duration involves close observation and follow-up during this timeframe to evaluate the study outcomes.

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. James's 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 2:1 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 study's 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 participant's 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 investigating treatments for children aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria, conditions where the kidneys do not function properly and leak protein into the urine. CKD can cause complications like high blood pressure, and treatments currently include ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) that help control blood pressure and protein levels. This study focuses on evaluating the safety and effects of adding finerenone to these standard treatments, aiming to better manage the overactive kidney system involved in these conditions. Participants will receive finerenone orally, adjusted by age and body weight, alongside their existing ACEI or ARB treatment. The study lasts about 19 months, with up to 18 months of finerenone treatment and a one-month follow-up. During this time, children who are new to finerenone will have at least 12 visits, while those already on finerenone will have at least 8 visits. At these visits, various health checks and sample collections will occur to monitor safety and kidney function. Throughout the study, researchers will regularly measure blood pressure, heart rate, temperature, height, and weight, and collect blood and urine samples to assess kidney function and protein levels. They will also perform heart tests using electrocardiograms and echocardiography. Participants and their guardians will answer questions about medication use and any medical problems experienced. Safety will be closely monitored by tracking any adverse events during the study and a health check will be done about 30 days after treatment ends.

Researchers are investigating whether adding finerenone to standard treatments with ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) can better help children aged 6 months to under 18 years who have chronic kidney disease (CKD) and proteinuria. CKD is a long-term condition where the kidneys do not filter blood properly, leading to waste buildup and protein leakage into urine. Managing blood pressure and proteinuria is important because these factors affect kidney health and disease progression. This is a phase 3, randomized, double-blind, placebo-controlled study sponsored by Bayer. Participants will receive either finerenone or a placebo, in addition to their usual ACEI or ARB treatment, for about 180 days. Before treatment, two screening visits over up to 104 days will confirm eligibility. During the treatment phase, participants will visit the study site at least seven times for health checks including blood pressure, heart rate, physical exams, blood and urine tests, electrocardiograms, and echocardiography. Researchers will monitor kidney function, protein levels in urine, blood electrolytes, and the presence of finerenone in the blood. Throughout the study, participants and their caregivers will answer questions about medication experience and any medical problems. Safety is closely observed, with adverse events recorded from treatment start to 30 days after finishing. The main outcome measured is the change in urinary protein-to-creatinine ratio after treatment, indicating kidney function improvement. The total participation lasts about 6 months, including treatment and follow-up.

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.