Primary Membranous NephropathyPhase 2/3OLYMPUSNCT07204275
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
A Phase 2/3 study testing Povetacicept and Tacrolimus in people with Primary Membranous Nephropathy, run by Vertex Pharmaceuticals Incorporated at 117 sites in 14 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- Povetacicept and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 117 sitesin 14 countries
- Study dates
- 30 Sep 2025to 29 Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with pMN with confirmatory historical biopsy. If no historical biopsy was performed that confirmed pMN, a biopsy can be performed during Screening to confirm eligibility
Who cannot join
- Hypersensitivity to investigational medicinal product or to any of its excipients
- Other protocol defined Inclusion/Exclusion criteria will apply
Trial locations and contacts
117 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
117 sites in 14 countries
China34 sites, 33 recruiting
- Recruiting
The First Affiliated Hospital of Baotou Medical College
Baotou
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing
- Recruiting
Peking University First Hospital
Beijing
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu
- Recruiting
The Second Norman Bethune Hospital of Jilin University
Changchun
- Recruiting
Xiangya Hospital of Central South University
Changsha
- Recruiting
Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
Chengdu
- Recruiting
Dalian Municipal Central Hospital
Dalian
- Recruiting
Dongguan People's Hospital
Dongguan
- Recruiting
Fuyang People's Hospital
Fuyang
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou
- Withdrawn
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou
- Recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Harbin
- Recruiting
The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University
Huai'an
- Recruiting
The Second Qilu Hospital of Shandong University
Jinan
- Recruiting
Liu Zhou Works Hospital
Liuzhou
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning
- Recruiting
Nanyang Central Hospital
Nanyang
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo
- Recruiting
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai
- Recruiting
Shanghai General Hospital
Shanghai
- Recruiting
Shenjing Hospital of China Medical University
Shenyang
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
- Recruiting
The Fourth Hospital of Hebei Medical Univesrsity
Shijiazhuang
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang
- Recruiting
Tai'an City Central Hosptial
Tai’an
- Recruiting
Weifang People's Hospital
Weifang
- Recruiting
Wuxi People's Hospital
Wuxi
- Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
- Recruiting
Yantai YuHuangDing Hospital
Yantai
- Recruiting
Yichang Central People Hospital
Yichang
United States28 sites, 28 recruiting
- Recruiting
Western Nephrology & Metabolic Bone Disease PC
Arvada, Colorado, 80002
- Recruiting
CARE Institute-Boise Kidney
Boise, Idaho, 83706
- Recruiting
DaVita Clinical Research Columbus
Columbus, Georgia, 31904
- Recruiting
DaVita Clinical Research Edina
Edina, Minnesota, 55435
- Recruiting
El Paso Kidney Specialists
El Paso, Texas, 79902
- Recruiting
Metrolina Nephrology Associates, PA
Gastonia, North Carolina, 28204
- Recruiting
Carolina Nephrology Greenville
Greenville, South Carolina, 29605
- Recruiting
NANI Research
Hinsdale, Illinois, 60521
- Recruiting
Provecta Research Network
Houston, Texas, 77027
- Recruiting
DaVita Clinical Research Houston
Houston, Texas, 77054
- Recruiting
Nephrology Associates of Northern Illinois and Indiana (NANI) - Indianapolis South
Indianapolis, Indiana, 46227
- Recruiting
Kidney Specialists of Southern Nevada
Las Vegas, Nevada, 89107
- Recruiting
Georgia Nephrology
Lawrenceville, Georgia, 30046
- Recruiting
Academic Medical Research Institute (AMRI)
Los Angeles, California, 90022
- Recruiting
Bioresearch Partner
Miami, Florida, 33127
- Recruiting
Renal Associates
Montgomery, Alabama, 36117
- Recruiting
NYU Medical Center
New York, New York, 10016-9196
- Recruiting
CTR Oakwater, LLC
Orlando, Florida, 32806
- Recruiting
St. Clair Nephrology Research
Roseville, Missouri, 48066
- Recruiting
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825
- Recruiting
Utah Kidney Research
Salt Lake City, Utah, 84115
- Recruiting
Davita Clinical Research San Antonio
San Antonio, Texas, 78251
- Recruiting
Northwest Louisiana Nephrology, LLC - Shreveport
Shreveport, Louisiana, 71101
- Recruiting
Carolina Nephrology, PA
Spartanburg, South Carolina, 29306
- Recruiting
Southwest Kidney Institute, PLC (SKI) - Surprise
Surprise, Arizona, 85374
- Recruiting
Valiance Clinical Research - Internal Medicine
Tarzana, California, 91356
- Recruiting
Milwaukee Neprologists, SC
Wauwatosa, Wisconsin, 53226
- Recruiting
Clinical Site Partners, LLC - Orlando
Winter Park, Florida, 32789
Japan8 sites, 8 recruiting
- Recruiting
Kanazawa University Hospital
Kanazawa
- Recruiting
Kasugai Municipal Hospital
Kasugai
- Recruiting
St.Marianna University School of Medicine Hospital
Kawasaki-shi
- Recruiting
Okayama University Hospital
Okayama
- Recruiting
Nagoya University Hospital
Shōwaku
- Recruiting
The University of Osaka Hospital
Suita
- Recruiting
Fujita Health University
Toyoake-Shi
- Recruiting
Juntendo University Urayasu Hospital
Urayasu
South Korea7 sites, 7 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si
- Recruiting
Korea University Anam Hospital - Nephrology
Seoul
- Recruiting
Korea University Guro Hospital - Nephrology
Seoul
- Recruiting
Kyung Hee University Hospital at Gangdong - Nephrology
Seoul
- Recruiting
Samsung Medical Center - Nephrology
Seoul
- Recruiting
Severance Hospital, Yonsei University Health System - Nephrology
Seoul
- Recruiting
Yongin Severance Hospital - Nephrology
Yongin-si
Brazil6 sites, 6 recruiting
- Recruiting
Freire Pesquisa Clinica
Belo Horizonte
- Recruiting
Hospital das Clinicas da Universidade Federal de Goias
Goiânia
- Recruiting
Santa Casa de Misericordia
Porto Alegre
- Recruiting
Universidade Federal de Pernmabuco
Recife
- Recruiting
Fundação Bahiana de Infectologia
Salvador
- Recruiting
Hospital das Clinicas da Faculdade de Medicina da USP - HC- FMUSP
São Paulo
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Vall D Hebron
Barcelona
- Recruiting
Hospital Universitario Reina Sofia
Córdoba
- Recruiting
Hospital de Vinalopó
Elche
- Recruiting
Hospital Ribera Polusa
Lugo
- Recruiting
Clinica Universidad de Navarra - Nefrología
Pamplona
- Recruiting
Hospital Universitario Virgen de la Macarena - Nefrología
Seville
United Kingdom6 sites, 6 recruiting
- Recruiting
University Hospital of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
Derby
- Recruiting
Doncaster and Bassetlaw Hospitals NHS Foundation Trust - Doncaster Royal Infirmary
Doncaster
- Recruiting
NHS Lothian - Royal Infirmary of Edinburgh
Edinburgh
- Recruiting
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London
- Recruiting
St George's University Hospitals NHS Foundation Trust - St George's Hospital- Renal Medicine
London
- Recruiting
The Royal Wolverhampton NHS Trust - New Cross Hospital
Wolverhampton
Italy5 sites, 5 recruiting
- Recruiting
AOU Consorziale Policlinico di Bari - Nefrologia, Dialisi e Trapianti
Bari
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
- Recruiting
Fondazione Salvatore Maugeri - Nefrologia e Dialisi
Pavia
Australia4 sites, 4 recruiting
- Recruiting
Monash Medical Centre
Clayton
- Recruiting
Concord Repatriation General Hospital
Concord
- Recruiting
St George Private Hospital
Kogarah
- Recruiting
University of Newcastle - John Hunter Hospital (JHH)
New Lambton Heights
Germany4 sites, 4 recruiting
- Recruiting
Charite - Universitaetsmedizin Berlin Campus Benjamin Frankl
Allemagne
- Recruiting
Klinikum St. Georg gGmbH - Nephrology
Leipzig
- Recruiting
Universitaetsklinikum Leipzig - Medizinische Klinik und Poliklinik III - Klinik und Poliklinik fuer Endokrinologie, Nephrologie
Leipzig
- Recruiting
Universitaetsklinikum Wuerzburg - Innere Medizin, Nephrologie
Würzburg
Ireland4 sites, 4 recruiting
- Recruiting
Cork University Hospital - Nephrology
Cork
- Recruiting
Beaumont Hospital
Dublin
- Recruiting
St. Vincent'S University Hospital
Dublin
- Recruiting
University Hospital Galway
Galway
Czechia2 sites, 2 recruiting
- Recruiting
FN Kralovske Vinohrady - Interni klinika
Prague
- Recruiting
Vseobecna fakultni nemocnice v Praze - Klinika nefrologie
Prague
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC - Nephrology
Amsterdam
- Recruiting
Radboud universitair medisch centrum / RADBOUDUMC - Nephrology
Nijmegen
Hungary1 site, 1 recruiting
- Recruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged
About this study
Official title: A Phase 2b/3 Adaptive, Randomized, Active-controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
- Conditions
- Primary Membranous Nephropathy
- Being tested
- Povetacicept, Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PovetaciceptDrug
Solution for Subcutaneous Injection.
TacrolimusDrug
Capsules for Oral Administration.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2b: Povetacicept | Experimental | Participants will be randomized to receive one of the two doses of Povetacicept. Receives: Drug: Povetacicept |
| Phase 3: Povetacicept | Experimental | Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b). Receives: Drug: Povetacicept |
| Phase 3: Calcineurin Inhibitor (CNI) | Active comparator | Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus. Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Complete Clinical Remission Definition 1 (CR1)
Measured: At Week 104
Secondary outcomes (3)
Proportion of Participants with Complete Clinical Remission Definition 2 (CR2)
Measured: At Week 104
Proportion of Participants with Overall Clinical Remission (OR)
Measured: At Week 104
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 up to Week 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start30 Sep 2025
- Primary completion29 Dec 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab (Shanghai) Co., Ltd. (for China only)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204275
- Sponsor's protocol ID
- VX24-AIS-D10
- Other IDs
- 2025-521661-27-00, 2025
- Acronym
- OLYMPUS
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b/3 Adaptive, Randomized, Active-controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT07204275
- Acronym / sponsor ID
- OLYMPUS / VX24-AIS-D10
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Zai Lab (Shanghai) Co., Ltd. (for China only)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 29 Dec 2028 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 2b: Povetacicept | Experimental | Drug: PovetaciceptParticipants will be randomized to receive one of the two doses of Povetacicept. |
| Phase 3: Povetacicept | Experimental | Drug: PovetaciceptParticipants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b). |
| Phase 3: Calcineurin Inhibitor (CNI) | Active comparator | Drug: TacrolimusParticipants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with pMN with confirmatory historical biopsy. If no historical biopsy was performed that confirmed pMN, a biopsy can be performed during Screening to confirm eligibility
Key exclusion criteria (2 listed)
- Hypersensitivity to investigational medicinal product or to any of its excipients
- Other protocol defined Inclusion/Exclusion criteria will apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PovetaciceptSolution for Subcutaneous Injection. | Drug | Phase 2b: Povetacicept, Phase 3: Povetacicept |
| TacrolimusCapsules for Oral Administration. | Drug | Phase 3: Calcineurin Inhibitor (CNI) |
Primary outcome
Proportion of Participants with Complete Clinical Remission Definition 1 (CR1)
Time frame: At Week 104
3 secondary outcomes
Proportion of Participants with Complete Clinical Remission Definition 2 (CR2)
Time frame: At Week 104
Proportion of Participants with Overall Clinical Remission (OR)
Time frame: At Week 104
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Week 112
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
Related trials for Primary Membranous Nephropathy
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Active, not recruitingPhase 1/2
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Lupus Nephritis, Immunoglobulin A Nephropathy
RecruitingPhase 2
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
Primary Membranous Nephropathy
RecruitingPhase 2
A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
Primary Membranous Nephropathy
RecruitingPhase 2/3
Combination of Rituximab and Cyclosporine in the Treatment of Primary Membranous Nephropathy
Membranous Nephropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
117 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Povetacicept and Tacrolimus in people with Primary Membranous Nephropathy, run by Vertex Pharmaceuticals Incorporated at 117 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 117 sites in China, United States, Japan, South Korea, Brazil and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Information (001-617-341-6777, medicalinfo@vrtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) (time frame: At Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.