Izhevsk

Researchers are evaluating the effects of a combined treatment of zibotentan and dapagliflozin compared to dapagliflozin alone in adults with chronic kidney disease (CKD) who have high levels of protein in their urine. This Phase II, multicenter, randomized, double-blind study aims to assess the efficacy, safety, and tolerability of this combination on top of standard care, including participants with or without type 2 diabetes mellitus (T2DM). The study will provide important clinical data for potential approval of this combination treatment in the Eurasian Economic Union. Participants may undergo a 28-day run-in period with dapagliflozin if they are not already using SGLT2 inhibitors at screening. Following this, they will enter a 12-week double-blind treatment period where they receive either the fixed-dose combination of zibotentan/dapagliflozin or dapagliflozin monotherapy once daily. After completing the treatment phase, all participants will receive open-label dapagliflozin alone during a 4-week safety follow-up period. Throughout the study, researchers will monitor changes in urinary albumin to creatinine ratio (UACR) from baseline at week 12 to evaluate treatment effects. Participants will be assessed regularly for safety, tolerability, and efficacy, with clinical evaluations including laboratory tests and monitoring of adverse events. The total study participation includes the run-in period, 12-week treatment, and a 4-week safety follow-up, ensuring comprehensive observation of treatment impact and participant health.

Researchers are conducting a national, multicenter, prospective study in the Russian Federation to collect real-world data on patients with aggressive, advanced endometrial cancer (stages III-IV). The study aims to understand the prevalence of molecular markers such as POLE mutations, dMMR/pMMR, p53 abnormalities, HER2, and PD-L1, as well as to observe first-line postoperative treatment approaches in these patients. Approximately 500 female patients with newly diagnosed aggressive subtypes of advanced endometrial cancer will be enrolled across about 30 sites. The study involves two visits aligned with routine clinical practice. At the first visit, demographic and clinical information will be collected from medical records or patient interviews, along with biopsy or archival tumor samples for molecular testing using immunohistochemistry and genetic sequencing methods. The second visit occurs six months after baseline or at disease progression, whichever is earlier, to gather follow-up data on treatments and disease status. No additional procedures beyond standard care are applied. Participants' data will be securely entered into electronic case report forms by study physicians. Researchers will monitor the rates of molecular markers such as POLE mutation positivity, mismatch repair status, p53 abnormalities, PD-L1 expression, and HER2 expression over 24 months. The overall study duration, from first patient enrollment to final data analysis, is expected to be about 27 months or until all data from 500 patients are collected, including follow-up information.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating the efficacy, safety, pharmacokinetics, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer (TNBC). This Phase 2 study focuses on patients who have received at least one prior systemic therapy and whose cancer has progressed or relapsed. The study aims to better understand how this combination treatment works in later lines of therapy for this aggressive breast cancer subtype. Participants will receive BCD-236 as an intravenous infusion along with chemotherapy, which will be chosen at the investigator's discretion. The study compares this combination treatment's effects and monitors participants over time. The primary outcome measured is the overall response rate at 24 weeks after starting treatment, assessing how well tumors respond to the therapy. Throughout the study, participants will undergo tumor assessments using RECIST 1.1 criteria to measure treatment response. Eligibility requires confirmation of AXL expression in tumor cells from fresh or archival tumor samples. Patients will be monitored for safety and disease progression, with evaluations including physical exams and performance status assessments. The study includes women aged 18 to 74 years with adequate health to participate and a life expectancy of at least four months.

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.

Researchers are conducting a large, non-interventional observational study to better understand adults with uncontrolled asthma across Russia. This study aims to gather detailed information on the demographic and clinical characteristics of these patients, the treatments they receive, and how their condition is managed in routine clinical practice. The study focuses on patients not treated with biologics and covers a diverse population from about 50 regions in Russia, reflecting differences in ethnicity, climate, and economic status. The study will include 9,000 adult patients with uncontrolled mild to moderate asthma who are receiving standard care. Data will be collected during 2-3 visits that follow routine clinical practice schedules. At the first visit, information from the previous 52 weeks will be gathered from medical records and patient interviews. The second visit will take place about 12 weeks later to collect follow-up data on treatment changes and clinical outcomes. For a subgroup of 500 patients using a fixed-dose combination of budesonide/salbutamol at the second visit, an additional third visit will occur 12 weeks later to further monitor treatment and outcomes. Participants will be monitored through medical record reviews and interviews during these visits. Researchers will assess baseline characteristics such as blood eosinophil counts, sputum eosinophils, and total IgE levels, along with treatment profiles and clinical outcomes. The study does not involve any experimental interventions beyond standard care and aims to provide comprehensive real-world data on uncontrolled asthma management in Russia. The total study duration for participants includes up to 24 weeks of follow-up for some patients.

Researchers are conducting a multi-center, non-interventional study to observe routine diagnostic and treatment practices for patients with unresectable or inoperable locally advanced non-small cell lung cancer (NSCLC) and limited-stage small cell lung cancer (LS-SCLC) in 50 major oncology centers across Russia. The study will collect data from 2000 patients receiving chemo-radiation therapy (CRT) over two years. The aim is to understand demographic and clinical characteristics, diagnostic procedures, treatment approaches, and short-term outcomes of CRT in these patients, without collecting information on treatments following CRT such as durvalumab. The study involves collecting data at two main points: at the start of CRT (either concurrent or sequential chemo-radiation) and after the last dose of radiation therapy, including results from computed tomography (CT) scans. Data collection will be done from patients' medical records in routine clinical practice, and the second data collection is expected to occur within six months after the first visit. The study follows local regulations for adverse event reporting and does not involve additional interventions or treatments. Participants will be adults aged 18 years or older who have locally advanced NSCLC or LS-SCLC and are currently undergoing radiation therapy as part of CRT. Researchers will gather information on patient demographics, disease stage, histology, and clinical status at baseline. The study will monitor treatment details and short-term outcomes after CRT. All data is collected from existing medical records, ensuring no extra procedures for participants. The total participation duration aligns with routine treatment schedules and follow-up visits.

Researchers are evaluating the effectiveness and safety of olokizumab (OKZ) compared to a placebo in patients with progressive fibrosing interstitial lung diseases (ILD). This phase 2/3 study uses a double-blind, parallel-group, adaptive design to assess treatment impact on lung function. Progressive fibrosing ILD is confirmed by imaging and lung function tests, with disease progression criteria including declines in lung capacity and worsening symptoms. Participants will receive subcutaneous injections of either 64 mg olokizumab or placebo every 4 weeks during a 48-week double-blind treatment period. The study begins with a 4-week screening period before treatment starts. After completing treatment, all participants enter a 24-week follow-up phase with visits at weeks 52, 60, and 72 to monitor ongoing effects and safety. Throughout the study, patients will undergo lung function tests, imaging reviews, and assessments of respiratory symptoms. Researchers will measure changes in forced vital capacity (FVC) over 48 weeks as the primary outcome. Safety and adverse events will be monitored during treatment and follow-up. The total participation time is about 76 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy (aromatase inhibitors with or without GnRH agonists) in patients with hormone receptor-positive, HER2-negative stage II-III breast cancer in Russia. The study includes both a prospective cohort receiving ribociclib plus hormone therapy and a retrospective cohort treated with hormone therapy alone. The goal is to assess treatment outcomes in different patient subgroups defined by tumor grade, lymph node involvement, and hormone therapy response. Participants in the prospective group receive ribociclib alongside aromatase inhibitors, with or without GnRH agonists, as part of their adjuvant therapy. The retrospective group includes patients treated with aromatase inhibitors alone during a specific period from July 2019 to July 2020. The study collects new data from the prospective group while also analyzing existing patient records from the retrospective group. Throughout the study, researchers monitor invasive breast cancer-free survival at 36, 48, and 60 months following treatment according to standardized criteria. Patient information is gathered from clinical records, including hormone therapy start dates and treatment responses. Safety and effectiveness are assessed by tracking outcomes over several years to better understand ribociclib's role in routine clinical practice for this type of breast cancer.