Opemalirsen for Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called opemalirsen for individuals with kidney problems. The goal is to assess the drug's movement through the body and its safety and tolerability, comparing those with kidney issues to healthy individuals. Participants will receive a single injection as part of the study. This trial may suit those with chronic kidney disease who have stable kidney function and are not on dialysis. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
Participants with kidney disease should be on a stable dose of their current medications for at least 2 weeks before screening. However, certain medications that affect creatinine clearance should not be used within 7 days before the study starts.
Is there any evidence suggesting that opemalirsen is likely to be safe for humans?
Research shows that opemalirsen is still being tested for safety in people with kidney problems. As this is an early phase study, detailed safety information is limited. However, these early studies focus on understanding how well people can handle the drug, identifying any side effects, and determining how the body processes the drug.
In an early phase, basic safety is still under evaluation. These studies are usually small and closely monitored. Researchers carefully observe participants' reactions to ensure their safety. The goal is to identify any potential risks before proceeding to larger studies.
Specific information on side effects for opemalirsen is not yet available, as researchers are still collecting crucial safety data at this stage.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Opemalirsen for kidney disease because it offers a novel approach to treatment. Unlike current standard therapies, which often focus on managing symptoms and slowing disease progression, Opemalirsen is administered as a single subcutaneous injection, potentially offering a more convenient and less invasive option. Additionally, it targets the underlying mechanisms of kidney impairment, which could lead to more effective outcomes. This innovative approach has the potential to improve quality of life for patients with varying degrees of renal impairment.
What evidence suggests that opemalirsen might be an effective treatment for kidney disease?
Research shows that opemalirsen is designed to manage kidney disease by influencing certain biological processes involved in the condition. Early findings suggest that opemalirsen affects drug movement through the body in individuals with kidney problems. Studies have shown that opemalirsen can target specific pathways, potentially slowing the progression of kidney disease. Although researchers are still gathering direct evidence of its effectiveness in treating kidney disease, early data on its mechanism is promising. More studies are needed to confirm its benefits and efficacy in patients with varying levels of kidney impairment. Participants in this trial will receive a single subcutaneous injection of AZD2373, with groups stratified by renal impairment level to assess its effects across different conditions.45678
Are You a Good Fit for This Trial?
This trial is for individuals with renal impairment or normal kidney function who may also have conditions like follicular lymphoma. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and agree to follow the study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous injection of opemalirsen and are monitored for PK, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1, 2, 3, and 8 weeks post-dose
What Are the Treatments Tested in This Trial?
Interventions
- Opemalirsen
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology