176 Participants Needed

Povetacicept for Membranous Nephropathy

(OLYMPUS Trial)

Recruiting at 13 trial locations
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Vertex Pharmaceuticals Incorporated
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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

Key
I have a confirmed diagnosis of primary membranous nephropathy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 2b

Participants are randomized to receive one of the two doses of Povetacicept

12 weeks

Treatment Phase 3

Participants are randomized to receive either the selected dose of Povetacicept or the calcineurin inhibitor Tacrolimus

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Povetacicept
Trial Overview The study is testing the effectiveness, safety, and how well people tolerate Povetacicept compared to Tacrolimus in treating pMN. It aims to see which treatment works better for this kidney condition.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Phase 3: PovetaciceptExperimental Treatment1 Intervention
Group II: Phase 2b: PovetaciceptExperimental Treatment1 Intervention
Group III: Phase 3: Calcineurin Inhibitor (CNI)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials
267
Recruited
36,100+
Dr. David Altshuler profile image

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani profile image

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

Citations

Vertex Presents Updated Phase 1/2 Data From RUBY-3 Study ...In pMN, key efficacy findings for the pove 80mg cohort at 48 weeks showed an 82% decrease from baseline in mean 24-hour UPCR, eGFR stabilization ...
Povetacicept for IgA Nephropathy and Primary ...Approximately 90% achieved hematuria resolution and 53% achieved clinical remission. Efficacy outcomes were similar with 240-mg povetacicept.
Povetacicept for IgA Nephropathy and Primary ...Approximately 90% achieved hematuria resolution and 53% achieved clinical remission. Efficacy outcomes were similar with 240-mg povetacicept.
Updated Results with Povetacicept, an Enhanced Dual...In an initial case report of pMN from the ongoing RUBY-3 study of povetacicept (NCT05732402), immunological remission was achieved at 22 wk, with anti-PLA2R1 ...
NCT07204275 | A Study to Evaluate Efficacy, Safety, and ...The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
Kidney WeekPovetacicept demonstrates promising activity in pMN, strongly supporting its further development in autoantibody-associated glomerulonephritis.
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