[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peter Rossing\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100611360","phase-4-a-biomarker-targeted-clinical-trial-to-optimize-treatment-for-patients-with-chronic-kidney-disease-100611360",false,"NCT07239570","A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease","A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease: A Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study","CKD-bioMatch","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 75 years\n2. UACR 100-5000 mg\u002Fg (11.3-565 mg\u002Fmmol) in two consecutive first-morning void urine samples at screening. (UACR 80-100 mg\u002Fg is accepted if historical measurements are above 100 mg\u002Fg and if it cannot be explained by any new treatment.)\n3. Stable treatment with a maximum tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for at least four weeks prior to randomization. (Unless such treatment is contraindicated or not tolerated.)\n4. Ability to communicate with the study staff and understand and sign the informed consent.\n\nExclusion Criteria:\n\n1. eGFR \\\u003C 25 mL\u002Fmin\u002F1.73m2 at screening.\n2. Treatment with two or all three of the study drugs\n3. History of pancreatitis at screening\n4. Body mass index \\\u003C 18.5 kg\u002Fm2 at screening\n5. Type 1 diabetes\n6. Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrollment\n7. NYHA class IV Congestive Heart Failure at screening\n8. Potassium \\> 5.0 mmol\u002FL at screening\n9. Addison's Disease\n10. Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin)\n11. Treatment with a potassium-sparing diuretic or a mineralocorticoid receptor antagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride)\n12. Elevated Alanine Aminotransferase (ALT) \\> 3 x upper normal limit at screening, autoimmune hepatitis, and\u002For severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt).\n13. Autosomal dominant or autosomal recessive polycystic kidney disease\n14. Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening\n15. Kidney transplant or dialysis\n16. Known or suspected hypersensitivity to the study medications or related products\n17. Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within five years before screening.\n18. Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements.\n19. A female who is pregnant, breastfeeding, or intends to become pregnant, or a woman of childbearing potential (WOCBP) who is not using highly effective contraceptive methods.\n20. Known or suspected abuse of narcotics.\n21. Participant in another intervention study.\n22. Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., not able to understand and sign the informed consent).","ALL","18 Years","75 Years",{"count":21,"type":22},125,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Over 800 million people worldwide suffer from chronic kidney disease (CKD), which is associated with a high individual disease burden for those affected, multiple secondary diseases, frequent doctor contacts, and hospitalizations, but also outstanding costs for the health system and the solidarity community. Appropriate interventions are essential to prevent the development and progression of CKD. In the past decade, great progress has been made in the search for drugs that can slow the progression of CKD. Sodium-glucose co-transporter 2 inhibitors, the non-steroidal mineralocorticoid receptor antagonist, finerenone, and the glucagon-like peptide-1 receptor agonist, semaglutide, have demonstrated albuminuria-lowering effects and kidney protection in people with CKD. Although these new pharmacological approaches show great promise, it is unclear how to optimally sequence and combine these therapies. In addition, the therapies are often not implemented due to treatment inertia and fear of adverse effects. This study aims to address this knowledge gap by utilizing a biomarker-guided treatment approach to reduce the decline in kidney function.\n\nThe aim of the CKD-bioMatch study is to evaluate the efficacy of a biomarker-targeted treatment approach versus standard of care in people with CKD and albuminuria. We hypothesize that a biomarker-targeted treatment approach is superior to standard of care at reducing estimated glomerular filtration rate (eGFR) decline in people with CKD.",[28],"Chronic Kidney Disease(CKD)",[30,31,32],"Chronic Kidney Disease","Personalized medicine","Biomarkers","RECRUITING","2025-11-18",{"date":36,"type":37},"2025-11-20","ACTUAL",{"date":39,"type":37},"2025-06-20",{"date":41,"type":22},"2028-06",{"name":43,"class":44},"Peter Rossing","OTHER",4,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100585723","phase-2-finerenone-treatment-for-diabetic-cardiovascular-autonomic-neuropathy-the-fibrocan-study-100585723","NCT06906081","Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study","FibroCAN","To be included in this study the participants must fulfill the following inclusion criteria.\n\n* Given informed consent\n* Type 2 diabetes defined by WHO criteria\n* Aged 40 ≥ at inclusion\n* Pathological E\u002FI ratio (Mean value of three measures)\n\nExclusion criteria Participants will be excluded in one or more of the following criteria are met.\n\n* No CAN (no abnormal CARTs)\n* Definite CAN (more than one abnormal CART)\n* HbA1C \\>100 mmol\u002FL\n* Treatment with potassium-sparing diuretics (amiloride) or MRAs e.g., spironolactone or eplerenone which cannot be discontinued 4 weeks prior to screening visit. The patient's primary physician, who is not involved in this study, will determine if discontinuation is possible.\n* Atrial fibrillation\u002Fflutter\n* Congestive heart failure (NYHA class 3-4)\n* History of cardiac arrhythmia\n* Severe forms of respiratory disease including asthma and COPD\n* Any nondiabetic cause of neuropathy\n* All female subjects of childbearing potential (WOCBP) must have a negative result of a highly sensitive urine HCG (pregnancy test) performed at screening. Subjects of childbearing potential must agree to use a highly effective form of contraception throughout the duration of the study (list of definition on WOCBP and accepted contraception in appendix A).\n* Severe hepatic impairment\n* Lactose intolerance\n* Breastfeeding\n* Nephropathy requiring dialysis\n* Beta-blocker-use\n* Hyperkalemia at screening visit (plasma potassium \\>4.8 mmol\u002Fl)\n* eGFR \\\u003C 25 ml\u002Fmin\u002F1.73m2\n* Potassium plasma \\> 4.8 mmol\u002Fl (at randomization)\n* Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit\n* Treament with moderate to strong CYP3A4-induceres (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort or efavirenz) which cannot be discontinued 4 weeks prior to screening visit\n* Have received chemotherapeutic treatment within last 12 months\n* Grapefruit consumption that cannot be discontinued during the study period\n* Inability to complete study protocol, assessed to investigator\n* Not able to read, write and\u002For understand Danish","40 Years",{"count":55,"type":22},100,[57],"PHASE2","Diabetic neuropathy is a serious and common complication of diabetes that currently has no cure. One form of this condition is cardiovascular autonomic neuropathy (CAN), which affects about 20% of people with diabetes-an estimated 100 million people worldwide. CAN is a significant risk factor for death and health problems like heart disease and kidney damage, and may contribute to the high rates of cardiovascular-related deaths in people with diabetes.\n\nThis study is a double-blind, randomized, placebo-controlled, two-center trial. The study aims to test whether finerenone can treat cardiovascular autonomic neuropathy in patients with type 2 diabetes. The trial will evaluate the effects of 78 weeks of treatment with finerenone or a placebo, assigned randomly in a 1:1 ratio, on early-stage cardiovascular autonomic neuropathy. The trial will include 100 participants with type 2 diabetes. Additionally, the study will investigate how the treatment impacts other types of neuropathy and related pathological mechanisms.",[60,61,62],"Cardiovascular Autonomic Neuropathy","Type 2 Diabetes","Diabetic Neuropathies",[64,65,61,66],"Mineralocorticoid receptor antagonist (MRA)","Cardiovascular autonomic neuropathy","Diabetic Neuropathy","2025-05-23",{"date":69,"type":37},"2025-05-25",{"date":71,"type":37},"2025-05-02",{"date":73,"type":22},"2028-01",{"name":43,"class":44},""]