Kartepe

Researchers are evaluating the safety and effectiveness 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 aims to provide important data on how iptacopan works in patients who have already responded to anti-C5 antibody treatment. The study is sponsored by Novartis Pharmaceuticals and focuses on key measures related to aHUS symptoms and kidney function. Participants will receive iptacopan at a dose of 200 mg twice daily during the treatment periods. The study includes an initial screening period lasting up to 14 weeks, followed by a 12-month core treatment phase and then a 12-month extension treatment phase. This design allows researchers to observe the effects of iptacopan over a full two years after switching from previous therapy. Throughout the study, participants will undergo regular assessments including blood tests for platelet count, LDH, hemoglobin, kidney function markers such as serum creatinine and eGFR, and urine protein levels. Researchers will monitor for signs of thrombotic microangiopathy TMA and kidney disease progression, as well as track the need for dialysis. Safety and clinical responses will be evaluated at multiple time points to understand the treatment impact and participant well-being.

This research aims to compare two surgical methods for treating genital apical prolapse, a condition where the top of the vagina, uterus, or cervix descends. It focuses on patients who have completed their fertile period and do not want to keep their uterus. The study evaluates laparoscopic pectopexy surgery with and without the use of mesh, a material sometimes linked to complications like mesh erosion, especially in obese patients where surgery is more challenging. Participants will undergo laparoscopic pectopexy surgery after hysterectomy. One group will have the vaginal cuff attached to the pectineal ligament using a non-absorbable suture without mesh, aiming to reduce mesh-related complications. The other group will have the vaginal cuff attached using polypropylene mesh, which is the standard technique. Both surgeries use a standard laparoscopic hysterectomy approach. During the study, patients will have their prolapse stage recorded before surgery and again 12 months after surgery. Quality of life related to prolapse will be assessed using a questionnaire before and one year after the operation. The main outcome measured is the rate of prolapse recurrence 12 months after surgery. Follow-up examinations will be conducted at 12 months post-surgery to evaluate results and safety. Participation lasts at least one year from surgery to follow-up assessment.

Researchers are evaluating the long-term effects of iptacopan in people with C3 glomerulopathy C3G or idiopathic immune-complex-membranoproliferative glomerulonephritis IC-MPGN. This open-label extension study focuses on assessing the safety, tolerability, and sustained efficacy of iptacopan over an extended period, following participants who completed earlier phase 2 or phase 3 studies. The study aims to provide important data to support regulatory submissions and continued access to treatment. Participants receive iptacopan capsules at a dose of 200 mg twice daily. The study includes different groups based on prior study participation and kidney status, including those with native kidneys and kidney transplants, as well as participants from core phase 3 studies who were randomized to placebo or iptacopan. This extension study is planned to continue until iptacopan becomes commercially available, the benefit-risk profile changes, or the program is discontinued, potentially lasting up to approximately 168 months. During the study, participants undergo regular efficacy and safety assessments, including monitoring of renal endpoints, adverse events, vital signs, electrocardiograms, and laboratory tests. Data collected includes urine protein and albumin levels, serum creatinine, estimated glomerular filtration rate, and complement C3 levels. The study expects participants to remain for a minimum of 60 months and up to 84 months, with the goal of understanding long-term treatment effects and tolerability.

Researchers are evaluating the efficacy and safety of iptacopan LNP023 in people aged 12 to 60 years with idiopathic immune complex-mediated membranoproliferative glomerulonephritis IC-MPGN. This Phase III, multicenter, randomized, double-blind, placebo-controlled study aims to examine whether iptacopan can reduce protein in the urine and improve kidney function compared to placebo. The study also looks at changes in patient-reported fatigue. IC-MPGN is linked to problems with the alternative complement pathway, which affects disease progression. Participants will receive either iptacopan 200 mg twice daily or a matching placebo, both given alongside standard care. Adolescents receive adjusted doses 2x100 mg b.i.d., while adults receive 200 mg b.i.d. The study includes a double-blind treatment period lasting 18 months. After this period, participants can either stop iptacopan and enter a 30-day safety follow-up or continue iptacopan treatment in an open-label extension study. During the study, participants will undergo regular urine collections to measure protein levels, kidney function tests eGFR, and assessments of fatigue using a patient questionnaire. Researchers will monitor safety through vital signs, ECGs, laboratory tests, and heart function parameters. The total participation lasts up to 18 months with additional safety follow-up or extension treatment options afterward.

Researchers are studying the effects of two drugs, propofol and ketamine, on the risk of cardiovascular collapse during the process of inducing anesthesia for endotracheal intubation in critically ill patients. The study focuses on how these drugs impact blood pressure and heart function since patients in critical care are at risk of severe drops in blood pressure or cardiac arrest during this procedure. The goal is to better understand which drug might help maintain heart stability in this vulnerable group. This observational study compares the incidence of cardiovascular collapse, defined as severe low blood pressure or cardiac arrest within the first 30 minutes after starting the drug, between patients given propofol or ketamine. It also examines related shock indices such as systolic and diastolic shock index, age-adjusted shock index, and modified shock index to assess the hemodynamic impact of each drug. The study does not involve randomization or treatment assignment but observes outcomes based on the induction agent used. Participants are critically ill adults over 18 years old who undergo intubation in the intensive care unit. Researchers monitor vital signs, including blood pressure and oxygen levels, and track any episodes of cardiovascular collapse or need for interventions like norepinephrine or fluid resuscitation. The main outcome is the occurrence of cardiovascular collapse within 30 minutes of drug administration. The study aims to inform safer drug choice during intubation and is expected to run until November 2025.