Kartepe

Researchers are investigating the long-term safety and tolerability of open-label iptacopan in adults with primary IgA nephropathy who have previously completed specific clinical trials (CLNP023X2203 or CLNP023A2301). This extension study is designed to allow participants continued access to iptacopan until certain conditions are met, such as reaching three years from the last patient first visit, loss of treatment benefit, negative benefit-risk profile, initiation of dialysis or kidney transplant, or commercial availability of the drug. The study will also assess the drug's effects on disease progression every six months. Participants who completed the prior trials and meet inclusion criteria may receive oral iptacopan capsules at a dose of 200 mg twice daily. The study is open-label and non-randomized and will continue treatment under this regimen until one of the study-defined stopping points is reached. Supportive care with ACE inhibitors or ARBs is maintained as per clinical guidelines, and vaccination against certain infections is required before enrollment. During the study, participants will be monitored for safety, including serious adverse events, adverse events of special interest, vital sign abnormalities, ECG changes, and laboratory test abnormalities from the first day of treatment until seven days after the last dose. Efficacy assessments occur every six months to evaluate clinical effects on disease progression. The study aims to collect long-term safety and tolerability data while providing ongoing treatment access until the drug becomes commercially available or other stopping criteria apply.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are investigating the effectiveness and safety of switching from anti-C5 antibody treatment to iptacopan in adults diagnosed with atypical hemolytic uremic syndrome (aHUS). This Phase 3, multicenter, single-arm, open-label study focuses on participants who have already been treated with anti-C5 antibodies and aims to assess the impact of iptacopan on aHUS symptoms and disease markers over time. Participants will first undergo a screening period lasting up to 14 weeks to confirm eligibility and clinical response to prior anti-C5 antibody treatment. Those who qualify will then enter a 12-month core treatment phase with iptacopan, followed by an additional 12-month extension period to monitor ongoing effects. Vaccinations against certain bacterial infections are required before starting iptacopan. During the study, participants will have regular assessments to monitor blood counts, kidney function, and other indicators relevant to aHUS. The main outcome measured is the percentage of participants who remain free of thrombotic microangiopathy (TMA) symptoms after 12 months. Safety and any side effects will also be closely observed throughout the treatment and extension periods, with total participation lasting up to two years.

This research aims to compare two surgical methods, laparoscopic pectopexy with and without mesh use, for treating genital apical prolapse, a condition where the vaginal apex, uterus, or cervix descends and requires surgical support. The study focuses on patients with stage 2 or higher pelvic organ prolapse who have completed their fertile period and do not want to preserve their uterus. It addresses concerns about mesh complications and explores safer options for prolapse surgery, especially after laparoscopic hysterectomy. Participants will undergo one of two laparoscopic pectopexy procedures: in one group, the vaginal cuff is attached to the pectineal ligament using polypropylene mesh, and in the other, the vaginal cuff is fixed without mesh using a non-absorbable Prolene suture. Both procedures aim to provide adequate apical support. The study includes an initial examination with POP-Q staging and a 12-month postoperative follow-up. During the study, patients will be assessed before surgery and again 12 months after the operation using the Prolapse Quality of Life Questionnaire to evaluate the impact of prolapse and treatment on quality of life. The primary outcome measured is the rate of vaginal cuff prolapse stage 2 or higher at 12 months post-surgery. Researchers will also monitor general health and surgical outcomes throughout the study period.

Researchers are evaluating the long-term effects of iptacopan (LNP023) in people with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis (IC-MPGN). This open-label extension study follows participants who have completed earlier Phase 2 or Phase 3 studies to gather more data on the drug's safety, effectiveness, and tolerability over an extended period. The study supports regulatory submissions by collecting long-term information about iptacopan's impact on these kidney conditions. Participants receive open-label iptacopan capsules, continuing treatment after completing prior studies CLNP023X2202, CLNP023B12301, or CLNP023B12302. The study includes adults and adolescents with C3G or IC-MPGN and allows continued access to the medication while collecting additional safety and efficacy data. The extension may last up to approximately 168 months or until the drug becomes commercially available or if the benefit-risk balance changes. During the study, researchers monitor participants regularly for kidney function, safety labs, vital signs, ECGs, and adverse events. They measure outcomes such as composite renal endpoints, changes in kidney tissue deposits, and incidence of safety concerns over 6 to 9 months and longer. Participants are expected to continue in the study from a minimum of 60 months up to 84 months or more, with ongoing assessments to support long-term safety and efficacy profiles of iptacopan.

Researchers are evaluating the effectiveness and safety of iptacopan (LNP023) in treating idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN) in this Phase III multicenter, randomized, double-blind, placebo-controlled study. The study includes adults and adolescents aged 12 to 60 years with confirmed IC-MPGN, aiming to reduce proteinuria, improve kidney function measured by estimated glomerular filtration rate (eGFR), and assess changes in patient-reported fatigue. The underlying mechanism involves dysregulation of the alternative complement pathway believed to drive the disease's progression. Participants will be assigned to receive either iptacopan 200 mg twice daily or a matching placebo, both alongside their standard care. Adolescents receive two 100 mg doses twice daily. The treatment period is double-blind and lasts 6 months, followed by an 18-month assessment. After completing the study treatment, participants may either stop iptacopan and enter a 30-day safety follow-up or continue treatment in an open-label extension study for longer-term evaluation. During the study, participants will undergo urine collections, kidney function tests, and patient questionnaires to monitor proteinuria levels, kidney function, and fatigue. The primary outcome is the change in urine protein-to-creatinine ratio from baseline at 6 and 18 months. Safety and efficacy will be closely monitored throughout the study and follow-up periods to assess the impact of iptacopan compared to placebo.

Researchers are investigating the effects of two commonly used drugs, propofol and ketamine, on the risk of cardiovascular collapse during the induction phase of endotracheal intubation in critically ill patients. This observational study focuses on understanding how these drugs influence hemodynamic stability, particularly in vulnerable patients in the intensive care unit. Propofol is known to cause blood vessel dilation and reduce heart muscle strength, which can lead to low blood pressure, while ketamine tends to support blood pressure due to its sympathomimetic effects. The study compares the incidence of cardiovascular collapse, which includes severe low blood pressure or cardiac arrest, following the use of either propofol or ketamine during intubation. Additionally, it examines several shock indices such as systolic shock index, diastolic shock index, age-adjusted shock index, and modified shock index to better understand the hemodynamic impact of these agents. Participants are critically ill patients receiving intubation in the ICU, and the research aims to guide safer induction agent choices. Participants will be monitored closely during and after intubation to detect any cardiovascular collapse within the first 30 minutes following drug administration. Researchers will assess vital signs and shock indices to evaluate hemodynamic changes. The study includes adult ICU patients undergoing intubation, with data collected on their response to either propofol or ketamine. Safety monitoring focuses on early cardiovascular events, and the total participation involves the intubation procedure and immediate post-induction period.