RecruitingPHASE2, PHASE3INTERVENTIONAL

Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)

This research study is looking into a new treatment called povetacicept for a kidney disease known as primary membranous nephropathy (pMN). In pMN, the filters in your kidneys become damaged, which can lead to problems like swelling and fatigue. The study wants to find out if povetacicept is a safe and effective way to treat this condition. Researchers will also compare it to an existing treatment, tacrolimus. This is a Phase 2/3 study, meaning it's still in the middle and later stages of testing new medicines. If you have pMN and are between 18 and 75 years old, you might be able to take part. The goal is to find better treatment options for people living with pMN.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Vertex Pharmaceuticals Incorporated

Enrolment target

176

Start

30 Sep 2025

Estimated completion

29 Dec 2028

Primary Membranous Nephropathy

What is this study about?

This study is exploring a new medication called povetacicept for a kidney condition known as primary membranous nephropathy, or pMN. In pMN, the tiny filters inside your kidneys (called glomeruli) become damaged. This damage makes it harder for your kidneys to clean your blood properly, leading to symptoms like swelling, foamy urine, and feeling very tired.

The main aim of this research is to see if povetacicept can help treat pMN. Researchers will be looking at how well it works (its 'efficacy') – for example, if it improves kidney function or reduces symptoms. They will also carefully check if the treatment is safe and if people can take it without too many side effects ('tolerability'). Some people in the study will receive povetacicept, while others will receive tacrolimus, which is another treatment for pMN, so doctors can compare the two.

Studies like this are vital because they help scientists understand new medicines better. If povetacicept is found to be safe and effective, it could become a new treatment option for people with pMN in the future. This is a 'Phase 2/3' study, which means it's an important step in testing new medicines, following initial safety checks and before it can be considered for wider use.

Key takeaways

This study is for people with Primary Membranous Nephropathy (pMN).
It's testing a new medicine called povetacicept.
The study compares povetacicept to an existing treatment, tacrolimus.
It aims to check how well the new medicine works and if it's safe.
Participants must be between 18 and 75 years old.
You'll have regular medical check-ups if you join.

Who may be eligible?

To be considered for this study, you must be between 18 and 75 years old. A key requirement is that you must have a confirmed diagnosis of primary membranous nephropathy (pMN). This diagnosis usually needs to be proven through a kidney biopsy.

If you've had a biopsy in the past that confirmed pMN, that's great. If not, don't worry – a biopsy can be performed as part of the screening process to make sure you have the condition and can join the study. Men and women are both welcome to participate.

However, you would not be able to join if you are allergic to the study medication (povetacicept) or any of its ingredients. There are also other 'rules' for who can and cannot join, which the study team will discuss with you in full detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Have you been diagnosed with primary membranous nephropathy (pMN)?
Have you had or are you willing to have a kidney biopsy to confirm pMN?
Are you happy to receive either the new study drug or an existing treatment?
Are you not allergic to povetacicept or any of its ingredients?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either povetacicept or tacrolimus as your study medicine. You would have regular visits to the clinic for check-ups and assessments. These visits would involve things like blood and urine tests to monitor your kidney function and overall health. Doctors would also ask you about any side effects or how you are feeling.

The study would involve taking the study medication according to a specific schedule, and you would be closely monitored throughout. After the main treatment period, there would likely be a follow-up period to see how you are doing in the longer term. The total length of your participation would be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you would receive a new, unapproved treatment (povetacicept) or an existing treatment (tacrolimus) for your pMN, along with close medical supervision. This might lead to an improvement in your condition. However, there's no guarantee that the treatment will work for you, or that it will be better than other available options. Potential risks include side effects from the study medication, which the study team will explain in full detail. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (93)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Renal Associates
Verified postcode
Montgomery, United States· Recruiting
Southwest Kidney Institute, PLC (SKI) - Surprise
Verified postcode
Surprise, United States· Recruiting
Academic Medical Research Institute (AMRI)
Verified postcode
Los Angeles, United States· Recruiting
Valiance Clinical Research - Internal Medicine
Verified postcode
Tarzana, United States· Recruiting
Western Nephrology & Metabolic Bone Disease PC
Verified postcode
Arvada, United States· Recruiting
Bioresearch Partner
Verified postcode
Miami, United States· Recruiting
CTR Oakwater, LLC
Verified postcode
Orlando, United States· Recruiting
Clinical Site Partners, LLC - Orlando
Verified postcode
Winter Park, United States· Recruiting
DaVita Clinical Research Columbus
Verified postcode
Columbus, United States· Recruiting
Georgia Nephrology
Verified postcode
Lawrenceville, United States· Recruiting
CARE Institute-Boise Kidney
Verified postcode
Boise, United States· Recruiting
NANI Research
Verified postcode
Hinsdale, United States· Recruiting

Common questions

What is primary membranous nephropathy (pMN)?

It's a kidney disease where the filters in your kidneys get damaged, making it harder for them to remove waste from your blood. This can lead to swelling and tiredness.

What is povetacicept?

It's a new medicine being tested in this study to see if it can help treat pMN. It's not yet approved for general use.

Will I definitely receive povetacicept if I join?

Not necessarily. In this type of study, you might receive povetacicept or another treatment called tacrolimus, chosen randomly, so researchers can compare them.

How long will I be in the study?

The study team will tell you the exact duration, which usually includes a treatment period and a follow-up period.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time for any reason, and it won't affect your medical care.

How to find out more

Medical Information

medicalinfo@vrtx.com 617-341-6777 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.