Polycystic Kidney Disease (PKD)

Researchers are evaluating the diagnostic accuracy of 68Ga-NYM096 PET/CT for detecting clear cell renal cell carcinoma (ccRCC) in patients with complex renal cysts scheduled for surgical removal. This phase 2, single-center, single-arm study aims to compare PET/CT results with histopathological diagnosis to assess sensitivity and specificity. The goal is to determine how well 68Ga-NYM096 PET/CT can identify ccRCC non-invasively before surgery. Each participant will receive a single intravenous dose of 68Ga-NYM096, followed by whole-body PET/CT imaging about 45 to 75 minutes after injection. Before surgery, contrast-enhanced CT scans of the abdomen and chest (if indicated) will be performed. PET/CT and CT images will be evaluated independently by blinded readers, and results will be compared with tissue analysis after kidney resection. The study will also explore PET/CT's ability to detect metastases compared to CT. Participants will undergo PET/CT and CT imaging prior to kidney surgery. The pathologist will analyze tumor tissue for histology, grading, and CAIX expression. Researchers will assess diagnostic accuracy measures such as sensitivity, specificity, and predictive values within one month after study completion. The study involves 39 patients and follows ethical and regulatory standards. Participation includes imaging, surgery, and histological testing over the study period ending in 2027.

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 effect of the hormone-related drug leuprorelin on liver growth in pre-menopausal women with very severe polycystic liver disease. The trial focuses on women whose liver volume continues to grow despite current treatments and who are at risk of needing a liver transplant. This phase 2, randomized, single-blind study is sponsored by the University Medical Center Groningen and aims to assess liver growth over 36 months. Participants are assigned to one of two groups: the direct start group receives leuprorelin injections for 36 months, beginning with monthly doses for the first three months followed by injections every three months; the delayed start group receives standard care for 18 months before starting leuprorelin for the next 18 months. The study monitors multiple health aspects including liver and kidney growth, hormone levels, bone density, and vital signs throughout the treatment period. Women involved in the trial will undergo regular MRI or CT scans, blood tests, and assessments of physical and mental health over three years. Researchers will track liver size changes as the primary outcome, along with symptoms related to liver disease, menopause, depression, and overall health. Safety is monitored by recording any serious adverse events, and participants provide informed consent before joining the study.

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 organ's 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 prospective national registry in Denmark to observe and collect data on percutaneous transluminal renal angioplasty (PTRA) in patients who have high-risk renovascular hypertension. This registry includes patients selected based on common national criteria and follows a standardized protocol across three Danish centers offering PTRA. The study aims to evaluate changes in blood pressure and other health outcomes after the procedure. The intervention being studied is percutaneous transluminal renal angioplasty, including angioplasty with stenting, especially in patients with fibromuscular dysplasia. Additional treatments such as antiplatelet therapy, cholesterol-lowering drugs, antihypertensive medications, and lifestyle measures like smoking cessation, diet, and physical activity are used according to the physician's discretion. The study monitors patients over time following their PTRA treatment. Participants undergo regular assessments including 24-hour ambulatory blood pressure monitoring and kidney function tests. The primary outcome measured is the change in systolic and diastolic blood pressures 24 months after PTRA in patients with elevated baseline blood pressure. Secondary outcomes include blood pressure changes at multiple time points, adjustments in antihypertensive treatment, kidney function changes, clinical and safety endpoints. Follow-up evaluations occur up to 60 months post-treatment to monitor long-term effects and safety.

Researchers are studying the effects of foam sclerotherapy on large kidney or liver cysts in patients with autosomal dominant polycystic kidney disease (ADPKD) and autosomal dominant polycystic liver disease (ADPLD). These cysts can cause discomfort and reduce quality of life, and this observational study aims to understand how foam sclerotherapy influences cyst size and patient-reported quality of life over a 12-month period. The study leverages a patient-reported outcome tool approved by the FDA to measure symptom burden in polycystic liver disease. The study observes patients who undergo foam sclerotherapy using 3% Sodium Tetradecyl Sulfate (Sotradecol®), a treatment currently approved for varicose veins. Patients have 1 to 3 large, non-exophytic cysts causing compressive symptoms, and researchers monitor changes in cyst volume and symptoms. The procedure targets cysts in the liver or kidney, and follow-up visits occur up to 12 months after treatment to assess changes. Participants will be assessed at baseline and then at 1 month, 6 months, and 12 months after treatment. Researchers collect data on pain, quality of life, and health-related quality of life using specialized questionnaires validated for this condition. Organ volumes are measured through imaging to track cyst changes. Patients must comply with follow-up visits, provide informed consent, and the study excludes those who are pregnant or have too many or too small cysts. Overall participation can last over a year to measure the treatment's impact.

Researchers are evaluating the long-term effects of enavogliflozin, a new sodium-glucose cotransporter-2 (SGLT2) inhibitor, in adults aged 19 and older with type 2 diabetes who have or are at risk for cardiovascular disease. This study aims to determine if enavogliflozin is not less effective than other SGLT2 inhibitors like dapagliflozin or empagliflozin in reducing major heart and kidney problems. The trial is a multicenter, randomized, open-label, active-controlled, non-inferiority study focusing on cardiorenal outcomes in the Korean population. Participants will be randomly assigned to receive enavogliflozin or either dapagliflozin or empagliflozin, with the dosing and administration guided by the investigator based on approved use and the participant's medical condition. The study includes an initial treatment period with follow-up assessments up to 48 months to monitor outcomes. The primary measurement is the time to the first major heart or kidney event, while secondary outcomes include rates of heart attacks, hospitalizations, deaths, kidney events, and progression of kidney damage. During the study, participants will have regular evaluations at 6, 12, 24, 36, and 48 months to assess cardiovascular and kidney health. Researchers will monitor hospitalizations, deaths, and kidney function changes using clinical records and laboratory tests. This long-term follow-up aims to clarify the role of enavogliflozin in preventing vascular complications in patients with type 2 diabetes and cardiovascular risk factors, with safety and outcomes carefully tracked throughout the study period.

Researchers are evaluating the safety and activity of sparsentan for treating adult patients with biopsy-confirmed immunoglobulin A nephropathy (IgAN), including newly diagnosed patients who have not received prior ACEI or ARB therapy (Cohort A) and patients with recurrent IgAN after kidney transplantation (Cohort B). This open-label, multi-center trial aims to explore sparsentan's potential to protect kidney function over an extended period. In Cohort A, patients will start sparsentan at 200 mg daily, increasing to a target dose of 400 mg daily after two weeks if tolerated, with dose adjustments allowed to maintain the highest tolerable dose. Treatment will continue for 110 weeks, followed by a 4-week off-treatment follow-up. Cohort B patients will be randomly assigned to receive sparsentan plus standard care for 48 weeks or standard care alone for 24 weeks before adding sparsentan for the remaining 24 weeks, then followed by a 4-week follow-up. Additional antihypertensive treatments are allowed except for ACEIs, ARBs, aldosterone blockers, or aliskiren. Participants will undergo assessments including urine protein excretion, estimated and measured glomerular filtration rate (GFR), kidney biopsy analysis using the Oxford Classification, MRI for kidney and heart function, bioimpedance for body water, and quality of life evaluations. Safety will be monitored through adverse events, lab tests, and vital signs. The primary outcome is urine protein/creatinine ratio at Week 36, with secondary outcomes assessing kidney function, proteinuria changes, and safety over up to 114 weeks.

Researchers are establishing the ADPKD Patient Registry, an online network designed to include at least 5,000 people diagnosed or suspected to have Autosomal Dominant Polycystic Kidney Disease (ADPKD). The goal is to support scientific research and patient needs by connecting patients with clinical study opportunities, collecting data on the disease experience, and measuring quality of life outcomes. This registry helps improve patient care and furthers understanding of ADPKD by gathering relevant health and demographic information while protecting patient privacy. Participants with ADPKD can join this secure, online registry accessible from home computers, tablets, or phones. Through the platform, patients contribute confidential health-related surveys to share their experiences and symptoms over time. The registry connects patients with researchers and offers chances to participate in clinical studies, including those testing new medications or treatments for ADPKD. During the study, researchers will review the number of people experiencing changes in health-related quality of life over one year. Patient data will be securely stored and used to inform future research on ADPKD outcomes and unmet needs. Participation involves completing surveys through the online platform, allowing ongoing engagement without physical visits. The registry is designed to be a long-term resource and will continue collecting data until at least September 2029.

Alport syndrome is a hereditary type IV collagen disease that typically causes kidney failure early in life. This observational study investigates whether various medications can delay disease progression, postpone kidney failure, and improve life expectancy compared to untreated relatives. The study began as a European registry in 2006 and has expanded globally as "Alport XXL" through the International Alport Alliance, focusing on early therapy outcomes in young patients using ACE-inhibitors, Angiotensin-receptor blockers, or their combination. The study collects data on patients at different disease stages, from early microscopic hematuria to kidney failure, to assess the effectiveness of early medication initiation. Patients are grouped by treatment status and disease severity, including untreated relatives and those receiving therapy at various stages. The registry records detailed clinical data, including genetic information, urine albumin levels, kidney function, and medication doses, in a strictly observational manner without intervening in treatment decisions. Participants provide retrospective and prospective data through standardized questionnaires at baseline and follow-up visits. Data collected include kidney function tests, blood pressure, hearing loss, eye involvement, and adverse events. Researchers measure outcomes such as age at kidney failure, life expectancy, kidney function decline, and changes in urinary albumin. The study aims to observe long-term effects of therapies until 2037, supporting improved understanding of treatment timing and effectiveness in Alport syndrome.