Chronic Glomerulonephritis

Researchers are evaluating a program called LINKED-HEARTS aimed at improving health outcomes for adults with uncontrolled high blood pressure who also have type 2 diabetes or chronic kidney disease. This trial involves 600 adults receiving care at community health centers and compares usual care with an enhanced program that includes home blood pressure monitoring linked to telemonitoring technology and team-based support. The goal is to reduce blood pressure, lower blood sugar levels, and improve kidney function through integrated clinical and community support. The study has two groups one receives enhanced usual care with home blood pressure monitors, and the other participates in the LINKED-HEARTS Program. Participants in the LINKED-HEARTS group will use the Omron 10 series blood pressure monitor with the Sphygmo telemonitoring app. They will also receive education and support from community health workers and telehealth visits with pharmacists who collaborate with providers to optimize medication. The enhanced usual care group also uses the blood pressure monitor with training but receives standard care from their primary doctors. Participants will measure and transmit blood pressure data using the telemonitoring app, and their health will be tracked over 12 months. Researchers will assess blood pressure control, changes in blood pressure readings, blood sugar levels, body mass index, kidney function, and quality of life. The study includes regular monitoring and support to help participants manage their chronic conditions. Total participation lasts at least one year, with outcome measurements at baseline, 12 months, and some quality of life assessments continuing to 24 months.

Researchers are studying how the drug MK-2828 behaves in the body over time, focusing on people with different levels of kidney disease compared to healthy individuals. This Phase 1 trial aims to understand the drugs pharmacokinetics, or how it is absorbed, distributed, metabolized, and eliminated in people with severe renal impairment, end-stage renal disease ESRD on hemodialysis, and healthy controls. Participants are divided into three groups based on kidney function. Those with severe renal impairment receive a single oral dose of MK-2828 on Day 1. Participants with ESRD on hemodialysis receive a single dose on Day 1 during two separate periods, with at least a 14-day break between doses. Healthy participants with normal kidney function also receive a single dose on Day 1. This open-label study does not involve randomization or blinding. During the trial, participants undergo blood sampling before dosing and at several time points up to 192 hours after receiving MK-2828 to measure drug concentrations and pharmacokinetic parameters. For those on hemodialysis, additional measurements related to dialysis clearance are collected up to 6 days. Safety is monitored by tracking adverse events for about two weeks. Participation lasts a few days depending on the dosing schedule and required sampling times.

Researchers are evaluating the use of sodium zirconium cyclosilicate SZC to help optimize renin-angiotensin aldosterone system inhibitor RAASi therapies in elderly patients aged 70 and older who have heart failure and chronic kidney disease. Many patients with these conditions do not receive recommended RAASi doses because of elevated potassium levels, which can be dangerous. This study aims to see if adding SZC allows safer and more effective use of RAASi medications by managing potassium levels. This is a randomized, open-label clinical trial where eligible participants who have been hospitalized for heart failure worsening and have mild or at-risk hyperkalemia will be assigned to one of two groups. One group receives SZC along with standard RAASi treatment, while the other receives RAASi treatment alone without potassium binders. The treatment period lasts three months, during which RAASi doses are adjusted following European Society of Cardiology guidelines. Participants will be monitored from screening through three months of treatment to measure how many can increase their RAASi doses by at least 25%. Evaluations include clinical assessments, potassium level monitoring, and adherence to therapy. The study will also track secondary outcomes related to higher dose increases. Safety and treatment effects will be observed throughout the trial, which is expected to provide important insights for managing these conditions in elderly patients.

Researchers are evaluating whether using an automated Carbon Dioxide CO2 injection system during infrainguinal peripheral vascular interventions PVI can reduce major adverse kidney events within 90 days in patients at moderately increased risk for contrast-associated acute kidney injury CA-AKI. This Phase 3 randomized controlled trial compares a CO2-based contrast medium sparing strategy to the standard use of iodinated contrast media in patients with peripheral vascular and kidney diseases. Participants are randomly assigned to one of two groups. The intervention group receives PVI using an automated CO2 injection system as the primary contrast agent, with iodinated contrast media available as a backup if image quality is insufficient or if the patient cannot tolerate CO2 angiography. The control group undergoes routine PVI using iodinated contrast media according to local standards, avoiding high-osmolar contrast agents. All patients are followed for up to 12 months after their procedure. During the study, participants undergo the planned PVI procedure with either contrast method. Researchers carefully record the amount and reasons for any iodinated contrast media used in the CO2 group. Patients are monitored for kidney-related outcomes, focusing on major adverse kidney events up to 90 days after the intervention. The trial includes ongoing follow-up assessments to evaluate safety and effectiveness over one year.

Researchers are studying the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of HS-10390 in healthy adults aged 18 to 45 years. This Phase 1 trial aims to understand how the drug behaves in the body and how well it is tolerated when taken in different doses. The study specifically involves healthy volunteers to gather initial data before testing in patients with conditions like IgA Nephropathy or Focal Segmental Glomerulosclerosis. The study uses a randomized, double-blind, placebo-controlled design with single and multiple ascending dose SAD and MAD periods. There will be about six sequential groups for single doses and three for multiple doses. Participants will receive oral tablets of HS-10390 or a matching placebo while fasting. The multiple dose phase begins after safety and PK data from the single dose phase are reviewed. A sentinel dosing approach is used in the first single dose group to enhance safety. Participants will be monitored from Day 1 up to Day 12 for single doses and up to Day 28 for multiple doses. Researchers will assess adverse events, serious adverse events, and any events leading to stopping the study drug. They will also measure drug levels in the blood over time to understand how quickly and extensively the drug is absorbed, distributed, and cleared. Safety checks include physical exams, lab tests, vital signs, ECGs, and imaging as needed. The total study duration varies by participant depending on the dosing schedule and monitoring requirements.

This research aims to evaluate the long-term safety of up to two injections of a gelatin-hydrogel formulation called Renal Autologous Cell Therapy REACT, given 3 to 6 months apart into the same kidney. The study focuses on participants with chronic kidney disease CKD who have previously received REACT in earlier clinical trials. The goal is to monitor how these treatments affect kidney function over time. This observational extension study involves up to 80 participants who were treated with REACT in prior interventional studies RMCL-002, REGEN-003, REGEN-004. Participants will be followed for up to five years through a series of alternating in-clinic and phone visits. No new treatments are given during this study rather, it is designed to observe the long-term effects after prior exposure to REACT. During the study, participants will undergo regular assessments to monitor kidney function and safety outcomes. Researchers will measure kidney function decline, dialysis requirements, and kidney transplant events over a 60-month period from the end of the previous trial. The study includes various safety checks and long-term follow-up to understand how REACT affects participants over several years.

Researchers are evaluating the investigational drug HTD1801 to see if it can slow kidney damage progression in adults who have both Type 2 Diabetes T2DM and Chronic Kidney Disease CKD. The main focus is to determine if HTD1801 can reduce or limit the increase in urine albumin-to-creatinine ratio UACR compared to a placebo. This Phase 2 randomized, double-blind study aims to understand the drugs effect on kidney function decline in this population. Participants will be randomly assigned to take either HTD1801 capsules 1000mg as 4 capsules or matching placebo capsules twice daily for 12 weeks. The study involves weekly clinic visits for the first 4 weeks, followed by visits every 4 weeks, during which various assessments and check-ups are conducted. The study drug or placebo is taken orally, and safety is closely monitored through health reports and routine laboratory tests. During the study, participants will attend scheduled visits for assessments including urine and blood tests to measure kidney function and other health markers. The primary outcome measured is the relative change in UACR from baseline at 12 weeks. Secondary outcomes include changes in estimated glomerular filtration rate eGFR, albumin excretion rate, inflammatory markers, blood sugar levels, and cholesterol. Safety monitoring continues throughout the trial to track any health changes or adverse effects.

Researchers are conducting a prospective, observational study to understand the full range of symptoms, treatment use, and overall quality of life experienced by patients with Immunoglobulin A nephropathy IgAN and their caregivers. The study aims to capture detailed data on these aspects over time to better reflect the patient experience and treatment patterns in the US. Participants will use the Folia Health mobile platform to enroll and provide data. The study includes IgAN patients taking different treatments such as iptacopan, atrasentan, other specific treatments, or no treatment, along with their caregivers. Each participant will complete a 6-month data collection period involving home-reported outcomes, baseline surveys, monthly check-ins, and an endline survey. After this period, participants may continue tracking symptoms for personal use, with optional data sharing for up to 2 years. During the study, participants report symptoms and treatment details monthly to assess symptom presence, severity, and variability. Researchers will also monitor treatment frequency, reasons for skipping treatment, and quality of life changes. Data collection includes patient-reported outcome scores and flare burden classification. The study involves no interventions and focuses on observation via the mobile app over the initial 6 months and potentially longer for ongoing data integration.

This research focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA dd-cfDNA to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organs status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA gDNA samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.

Researchers are conducting a Phase 2 study to evaluate the safety, pharmacodynamics, pharmacokinetics, and clinical activity of ADX-097 in male and female participants aged 16 years or older with Immunoglobulin A Nephropathy IgAN, Lupus Nephritis LN, or Complement Component 3 Glomerulopathy C3G. This study aims to better understand how ADX-097 works in these kidney-related conditions and to monitor its effects and safety profile. Participants will receive weekly subcutaneous injections of ADX-097. The study is open-label, meaning all participants receive the active drug without a placebo comparison. Treatment and observation will continue for up to 26 weeks, with regular dosing and monitoring throughout this period. During the study, participants will undergo various assessments including measurements of urine protein-to-creatinine ratio and estimated glomerular filtration rate to monitor kidney function. Blood samples will be taken at multiple time points to measure the concentration of ADX-097 in plasma. Safety will be closely monitored by recording any treatment-emergent adverse events over up to 30 weeks. The total participation duration may last until study completion in early 2028.