Povetacicept for Membranous Nephropathy
(OLYMPUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness and safety of povetacicept for individuals with primary membranous nephropathy (pMN), a kidney condition where the immune system damages the kidneys' filtering units. Participants will receive varying doses of povetacicept, with some compared to those taking the standard treatment, tacrolimus. This trial suits individuals diagnosed with pMN, confirmed by a kidney biopsy, who seek new treatment options. As a combined Phase 2 and Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering hope for new, effective treatment options.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that povetacicept is generally safe and well-tolerated for people with primary membranous nephropathy (pMN). Studies found no major safety concerns, and the results aligned with previous safety findings. Participants handled the treatment well, experiencing no severe side effects. These findings are encouraging for those considering joining the trial.12345
Why do researchers think this study treatment might be promising?
Povetacicept is unique because it targets a specific pathway in the immune system that contributes to membranous nephropathy, potentially offering a new approach compared to the current standard treatments like corticosteroids and calcineurin inhibitors. Unlike these standard treatments, which can have significant side effects and require long treatment durations, Povetacicept aims to provide a more targeted therapy, which could mean fewer side effects and a more direct attack on the disease's underlying cause. Researchers are excited about Povetacicept because it represents a novel mechanism of action, focusing on the immune system's role in kidney damage, offering hope for a more effective and safer option for patients.
What evidence suggests that this trial's treatments could be effective for membranous nephropathy?
Research has shown that povetacicept may help treat primary membranous nephropathy (pMN), a kidney condition. In one study, patients taking povetacicept experienced an 82% reduction in protein levels in their urine, indicating improved kidney function. Another study found that nearly 53% of patients achieved clinical remission, with symptoms greatly improving or disappearing. Additionally, povetacicept maintained stable kidney function by preserving the estimated glomerular filtration rate (eGFR). In this trial, participants will be randomized to receive one of two doses of povetacicept or the calcineurin inhibitor (CNI) Tacrolimus. These findings suggest that povetacicept could be a promising treatment for people with pMN.12346
Are You a Good Fit for This Trial?
This trial is for individuals who have been diagnosed with primary membranous nephropathy (pMN), confirmed by a past biopsy or one that can be done during screening if necessary.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 2b
Participants are randomized to receive one of the two doses of Povetacicept
Treatment Phase 3
Participants are randomized to receive either the selected dose of Povetacicept or the calcineurin inhibitor Tacrolimus
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Povetacicept
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology