Primary Membranous NephropathyPhase 2NCT05136456
Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy
A Phase 2 study testing SHR1459 Low Dose and SHR1459 High Dose in people with Primary Membranous Nephropathy, run by Reistone Biopharma Company Limited at 19 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy. 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?
- SHR1459 Low Dose and SHR1459 High Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 19 sitesChina
- Study dates
- 15 Dec 2021to 11 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Diagnosis of primary membranous nephropathy based on renal biopsy before or during screening
- Have not received any previous immunosuppressive therapy for primary membranous nephropathy or relapse after the treatment has achieved complete or partial remission (comprehensive judgment and recording by the investigator)
- PLA2R-Ab titer ≥20RU/mL at screening
- 24-hour urinary protein ≥ 3.5g/d at screening
- Have eGFR ≥ 60 mL/min/1.73 m2 (based on CKD-EPI formula) at screening
Who cannot join
- Any clue for coexist of secondary membranous nephropathy from medical records, laboratory tests or kidney biopsy
- Existence of clinically significant infection within 1 month before screening,
- Severe or not well controlled other complications
- Abnormal in white blood cell count, neutrophil count, lymphocyte count or platelet count at screening, which were considered unfit for participating judged by investigators
- ALT > 2 times ULN and/or AST > 2 times ULN and/or bilirubin >2 times ULN at screening
- Subject has evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
- Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody at screening;
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
The First Affiliated Hospital of Baotou Medical College
Baotou, Nei Monggol
The Second Hospital of Jilin University
Changchun, Jilin
Xiangya Hospital Central South University
Changsha, Hunan
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Jiangsu Province People's Hospital
Nanjing, Jiangsu
Zhongda Hospital affiliated to Southeast University
Nanjing, Jiangsu
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Tongji Hospital of Tongji University
Shanghai
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Zhongshan Hospital Xiamen University
Xiamen, Fujian
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu
Henan Provincial People's Hospital
Zhengzhou, Henan
About this study
Official title: A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR1459 Tablets in the Treatment of Primary Membranous Nephropathy (PMN)
The purpose of this study is to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.
Read the detailed description
This study is a phase II study to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.
- Conditions
- Primary Membranous Nephropathy
- Being tested
- SHR1459 Low Dose, SHR1459 High Dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR1459 Low DoseDrug
SHR1459 oral tablets taken once daily (QD) for 24weeks
SHR1459 High DoseDrug
SHR1459 oral tablets taken once daily (QD) for 24 weeks
PlaceboDrug
Placebo oral tablets taken once daily (QD) for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| SHR1459 Low Dose | Active comparator | Drug: SHR1459 SHR1459 oral 24weeks Receives: Drug: SHR1459 Low Dose |
| SHR1459 High Dose | Active comparator | Drug: SHR0302 SHR1459 oral 24 weeks Receives: Drug: SHR1459 High Dose |
| Placebo | Placebo comparator | Drug: Placebo Placebo oral 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving complete or partial remission at week 24
Proportion of subjects achieving complete or partial remission at week 24
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start15 Dec 2021
- Primary completion28 Aug 2023 (estimated)
- Study completion11 Mar 2024 (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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reistone Biopharma Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136456
- Sponsor's protocol ID
- RSB20926
- Status last verified
- Aug 2023
- First submitted
- 17 Nov 2021
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR1459 Tablets in the Treatment of Primary Membranous Nephropathy (PMN)
- ClinicalTrials.gov ID
- NCT05136456
- Acronym / sponsor ID
- RSB20926
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Reistone Biopharma Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 28 Aug 2023 (estimated)
- Study completion
- 11 Mar 2024 (estimated)
- First posted
- 29 Nov 2021 (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 and safety of SHR1459 tablets in patients with primary membranous nephropathy.
Detailed description
This study is a phase II study to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR1459 Low Dose | Active comparator | Drug: SHR1459 Low DoseDrug: SHR1459 SHR1459 oral 24weeks |
| SHR1459 High Dose | Active comparator | Drug: SHR1459 High DoseDrug: SHR0302 SHR1459 oral 24 weeks |
| Placebo | Placebo comparator | Drug: PlaceboDrug: Placebo Placebo oral 24 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of primary membranous nephropathy based on renal biopsy before or during screening
- Have not received any previous immunosuppressive therapy for primary membranous nephropathy or relapse after the treatment has achieved complete or partial remission (comprehensive judgment and recording by the investigator)
- PLA2R-Ab titer ≥20RU/mL at screening
- 24-hour urinary protein ≥ 3.5g/d at screening
- Have eGFR ≥ 60 mL/min/1.73 m2 (based on CKD-EPI formula) at screening
Key exclusion criteria (7 listed)
- Any clue for coexist of secondary membranous nephropathy from medical records, laboratory tests or kidney biopsy
- Existence of clinically significant infection within 1 month before screening,
- Severe or not well controlled other complications
- Abnormal in white blood cell count, neutrophil count, lymphocyte count or platelet count at screening, which were considered unfit for participating judged by investigators
- ALT > 2 times ULN and/or AST > 2 times ULN and/or bilirubin >2 times ULN at screening
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 |
|---|---|---|
| SHR1459 Low DoseSHR1459 oral tablets taken once daily (QD) for 24weeks | Drug | SHR1459 Low Dose |
| SHR1459 High DoseSHR1459 oral tablets taken once daily (QD) for 24 weeks | Drug | SHR1459 High Dose |
| PlaceboPlacebo oral tablets taken once daily (QD) for 24 weeks | Drug | Placebo |
Primary outcome
Proportion of subjects achieving complete or partial remission at week 24
Time frame: 24 Weeks
Proportion of subjects achieving complete or partial remission at week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR1459 Low Dose and SHR1459 High Dose in people with Primary Membranous Nephropathy, run by Reistone Biopharma Company Limited at 19 sites in China.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving complete or partial remission at week 24 (time frame: 24 Weeks). 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 5 Sep 2023.