Primary Membranous NephropathyPhase 2TEST-T-PMNNCT06614985
The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy
A Phase 2 study testing Telitacicept, Prednisone and Cyclophosphamide in people with Primary Membranous Nephropathy, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- Telitacicept, Prednisone and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 1 Oct 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a confirmed diagnosis of primary membranous nephropathy through renal biopsy to be eligible for inclusion in the study.
- Adult patients aged 18 years or older of any gender are eligible for inclusion in the study.
- Patients who meet the diagnostic criteria for nephrotic syndrome, which includes quantitative urine protein levels greater than 3.5 g/24 h and serum albumin levels less than 30 g/L, are eligible for inclusion in the study.
- Patients who meet the high-risk criteria for progression of membranous nephropathy based on the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines are eligible for inclusion in the study. High-risk criteria include eGFR less than 60 mL/min/1.73 m2 and/or urine protein excretion greater than 8 g/day for at least 6 months, or normal eGFR with urine protein excretion greater than 3.5 g/day and urine protein reduction less than 50% after 6 months of ACEI/ARB treatment, with any of the following criteria: serum albumin less than 25 g/L, anti-PLA2R antibody greater than 50 RU/mL, urine α1-microglobulin greater than 40 μg/min, urine IgG1 greater than 1 μg/min, urine β2-microglobulin greater than 250 mg/day, and SI greater than 0.2.
- Participants are required to consent to use effective contraception methods with their partners throughout the entire duration of the study. Participants must have a thorough understanding of the nature, significance, potential benefits, inconveniences, and potential risks of the study and voluntarily sign an informed consent form.
Who cannot join
- Secondary membranous nephropathy patients (caused by autoimmune or infectious diseases, tumors, etc.);
- Patients with HIV infection, viral hepatitis, active liver disease (with ALT/AST/bilirubin levels exceeding 3 times the upper limit of normal), or other severe infections;
- Patients with a rapid decline in eGFR (>15 mL/min) during the screening period are excluded;
- Patients who have undergone kidney transplantation or other organ transplantation;
- Patients with a known allergy or hypersensitivity to the active ingredient of the investigational drug or any of the listed excipients;
- Patients with acute or critical cardiovascular or cerebrovascular diseases;
Show all 12Show fewer
- Patients with immunodeficiency, hypoalbuminemia (IgG < 400 mg/dl), or IgA deficiency (IgA < 10 mg/dL);
- Pregnant or lactating women;
- Patients diagnosed with malignant tumors within the past 5 years;
- Laboratory findings of severe abnormalities (Hb < 80 g/L, PLT < 50,000/mm3, neutrophil count < 1,000/mm3, etc.);
- Patients who have used steroids or immunosuppressive agents (including but not limited to corticosteroids, adrenocorticotropic hormones, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine, biologic agents such as rituximab, etc.), cyclophosphamide, bortezomib, dexamethasone, Chinese medicines or preparations containing Tripterygium wilfordii, intravenous immunoglobulin, plasma exchange, leukapheresis, live vaccines, or other investigational drugs, etc., within 3 months prior to screening;
- Patients with other diseases or conditions that, in the opinion of the investigator, would render the patient unsuitable for participation in this study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy.
Read the detailed description
The study consists of four stages as follows:
- Screening period (0-6 months): After signing the informed consent form, subjects enter the screening period.
- Induction treatment period (3 months): Eligible subjects receive induction treatment with Methylprednisone 0.5 g i. v. for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 0.8 mg/kg/day, tapered gradually after 2 months (reduced by 5 mg every 2 weeks), and cyclophosphamide is administrated intravenously at a dose of 0.4 g/d twice a month.
- Group treatment period (6 months): Patients who complete the induction treatment period undergo an efficacy assessment to determine whether they achieve a complete remission or partial remission. Patients who do not achieve a complete remission or partial remission are defined as non-responders. Patients who achieve a complete remission or partial remission are randomized and enter the group A or group B. Patients of non-responders are randomized and enter the group C and group D. Patients in group A and C continue the initial treatment regimen for 6 months. Patients in group B and D commence hypodermic injection of Telitacicept 160 mg weekly 6 months with the continued administration of prednisone and cyclophosphamide in group D while discontinued cyclophosphamide administration in group B.
- Follow-up period (12 months): After completing 6 months of group treatment, cyclophosphamide or Telitacicept is discontinued with minimal dose of 5mg/d prednisone remained. All the patients are subjected to a 12-month follow-up.
- Conditions
- Primary Membranous Nephropathy
- Being tested
- Telitacicept, Prednisone, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
Subcutaneous injection of 160 mg is administered once a week.
PrednisoneDrug
Induction therapy period (3 months)：Eligible subjects receive induction treatment with Methylprednisone 0.5 g i. v. for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 0.8 mg/kg/day, tapered gradually after 2 months (reduced by 5 mg every 2 weeks) Grouped treatment period (6 months): The maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation.
CyclophosphamideDrug
An intravenous injection of 0.4 g is administered twice a month.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Patients who have achieved complete or partial remission are then randomly assigned to either Group A or Group B at a 1:1 ratio.
Medication regimen of Group A： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Cyclophosphamide injection：an intravenous injection of 0.4 g is administered twice a month. Receives: Drug: Prednisone; Drug: Cyclophosphamide |
| Group B | Experimental | Medication regimen of Group B： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Telitacicept injection：an intravenous injection of 0.4 g is administered twice a month. Receives: Drug: Telitacicept; Drug: Prednisone |
| Group C | Active comparator | After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Non-responders are randomly assigned to either Group C or Group D at a 1:1 ratio.
Medication regimen of Group C： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Cyclophosphamide injection：an intravenous injection of 0.4 g is administered twice a month. Receives: Drug: Prednisone; Drug: Cyclophosphamide |
| Group D | Experimental | Medication regimen of Group D： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Telitacicept injection：an intravenous injection of 0.4 g is administered twice a month. Receives: Drug: Telitacicept; Drug: Prednisone; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate at the end of follow-up (21 months post-treatment)
Complete remission defined as 24h urine protein quantification ≤0.3g/24h.
Measured: 21 months
Partial remission rate at the end of follow-up (21 months post-treatment)
Partial remission defined as 24h proteinuria quantification <3.5g/24h or ≥50% reduction from baseline and stable serum creatinine or <30% increase from baseline value.
Measured: 21 months
Secondary outcomes (4)
Incidence of relapse of nephrotic syndrome at months 3, 6, 9, 12, 15, 18, and 21 after treatment
Recurrence of proteinuria >3.5 g/24h or at least a ≥50% increase from the nadir was defined as recurrence of nephrotic syndrome in patients who had achieved partial or complete remission.
Measured: 3-21 months
Incidence of adverse events in each group
This trial specifies that the recording of adverse events shall be recorded as a medical history from the time the subject receives the induction phase treatment administration, and from the time of signing the informed consent form until the clinical diagnosis, abnormal signs and symptoms, and examination findings occurring prior to the administration of the induction phase treatment.
Measured: 0-21 months
Complete remission rate at months 3, 6, 9, 12, 15, 18, and 21 after treatment
Complete remission defined as 24h urine protein quantification ≤0.3g/24h.
Measured: 3-21 months
Partial remission rate at months 3, 6, 9, 12, 15, 18, and 21 after treatment
Partial remission defined as 24h proteinuria quantification <3.5g/24h or ≥50% reduction from baseline and stable serum creatinine or <30% increase from baseline value.
Measured: 3-21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start20 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (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
- Sequential
- Model description
- After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Patients who have achieved complete or partial remission are then randomly assigned to either Group A or Group B at a 1:1 ratio. Non-responders are also randomly assigned to either Group C or Group D at a 1:1 ratio. Treatment administration is subsequently carried out based on group assignment.
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiming Wang, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614985
- Sponsor's protocol ID
- Huiming Wang
- Acronym
- TEST-T-PMN
- Status last verified
- Sep 2024
- First submitted
- 30 May 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT06614985
- Acronym / sponsor ID
- TEST-T-PMN / Huiming Wang
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 26 Sep 2024 (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.
This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy.
Detailed description
The study consists of four stages as follows:
- Screening period (0-6 months): After signing the informed consent form, subjects enter the screening period.
- Induction treatment period (3 months): Eligible subjects receive induction treatment with Methylprednisone 0.5 g i. v. for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 0.8 mg/kg/day, tapered gradually after 2 months (reduced by 5 mg every 2 weeks), and cyclophosphamide is administrated intravenously at a dose of 0.4 g/d twice a month.
- Group treatment period (6 months): Patients who complete the induction treatment period undergo an efficacy assessment to determine whether they achieve a complete remission or partial remission. Patients who do not achieve a complete remission or partial remission are defined as non-responders. Patients who achieve a complete remission or partial remission are randomized and enter the group A or group B. Patients of non-responders are randomized and enter the group C and group D. Patients in group A and C continue the initial treatment regimen for 6 months. Patients in group B and D commence hypodermic injection of Telitacicept 160 mg weekly 6 months with the continued administration of prednisone and cyclophosphamide in group D while discontinued cyclophosphamide administration in group B.
- Follow-up period (12 months): After completing 6 months of group treatment, cyclophosphamide or Telitacicept is discontinued with minimal dose of 5mg/d prednisone remained. All the patients are subjected to a 12-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Patients who have achieved complete or partial remission are then randomly assigned to either Group A or Group B at a 1:1 ratio. Non-responders are also randomly assigned to either Group C or Group D at a 1:1 ratio. Treatment administration is subsequently carried out based on group assignment.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Prednisone, Drug: CyclophosphamideAfter completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Patients who have achieved complete or partial remission are then randomly assigned to either Group A or Group B at a 1:1 ratio. Medication regimen of Group A： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Cyclophosphamide injection：an intravenous injection of 0.4 g is administered twice a month. |
| Group B | Experimental | Drug: Telitacicept, Drug: PrednisoneMedication regimen of Group B： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Telitacicept injection：an intravenous injection of 0.4 g is administered twice a month. |
| Group C | Active comparator | Drug: Prednisone, Drug: CyclophosphamideAfter completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Non-responders are randomly assigned to either Group C or Group D at a 1:1 ratio. Medication regimen of Group C： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Cyclophosphamide injection：an intravenous injection of 0.4 g is administered twice a month. |
| Group D | Experimental | Drug: Telitacicept, Drug: Prednisone, Drug: CyclophosphamideMedication regimen of Group D： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Telitacicept injection：an intravenous injection of 0.4 g is administered twice a month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have a confirmed diagnosis of primary membranous nephropathy through renal biopsy to be eligible for inclusion in the study.
- Adult patients aged 18 years or older of any gender are eligible for inclusion in the study.
- Patients who meet the diagnostic criteria for nephrotic syndrome, which includes quantitative urine protein levels greater than 3.5 g/24 h and serum albumin levels less than 30 g/L, are eligible for inclusion in the study.
- Patients who meet the high-risk criteria for progression of membranous nephropathy based on the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines are eligible for inclusion in the study. High-risk criteria include eGFR less than 60 mL/min/1.73 m2 and/or urine protein excretion greater than 8 g/day for at least 6 months, or normal eGFR with urine protein excretion greater than 3.5 g/day and urine protein reduction less than 50% after 6 months of ACEI/ARB treatment, with any of the following criteria: serum albumin less than 25 g/L, anti-PLA2R antibody greater than 50 RU/mL, urine α1-microglobulin greater than 40 μg/min, urine IgG1 greater than 1 μg/min, urine β2-microglobulin greater than 250 mg/day, and SI greater than 0.2.
- Participants are required to consent to use effective contraception methods with their partners throughout the entire duration of the study. Participants must have a thorough understanding of the nature, significance, potential benefits, inconveniences, and potential risks of the study and voluntarily sign an informed consent form.
Key exclusion criteria (12 listed)
- Secondary membranous nephropathy patients (caused by autoimmune or infectious diseases, tumors, etc.);
- Patients with HIV infection, viral hepatitis, active liver disease (with ALT/AST/bilirubin levels exceeding 3 times the upper limit of normal), or other severe infections;
- Patients with a rapid decline in eGFR (>15 mL/min) during the screening period are excluded;
- Patients who have undergone kidney transplantation or other organ transplantation;
- Patients with a known allergy or hypersensitivity to the active ingredient of the investigational drug or any of the listed excipients;
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 |
|---|---|---|
| TelitaciceptSubcutaneous injection of 160 mg is administered once a week. | Drug | Group B, Group D |
| PrednisoneInduction therapy period (3 months)：Eligible subjects receive induction treatment with Methylprednisone 0.5 g i. v. for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 0.8 mg/kg/day, tapered gradually after 2 months (reduced by 5 mg every 2 weeks) Grouped treatment period (6 months): The maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation. | Drug | Group A, Group B, Group C, Group D |
| CyclophosphamideAn intravenous injection of 0.4 g is administered twice a month. | Drug | Group A, Group C, Group D |
Primary outcome
Complete remission rate at the end of follow-up (21 months post-treatment)
Time frame: 21 months
Complete remission defined as 24h urine protein quantification ≤0.3g/24h.
Partial remission rate at the end of follow-up (21 months post-treatment)
Time frame: 21 months
Partial remission defined as 24h proteinuria quantification <3.5g/24h or ≥50% reduction from baseline and stable serum creatinine or <30% increase from baseline value.
4 secondary outcomes
Incidence of relapse of nephrotic syndrome at months 3, 6, 9, 12, 15, 18, and 21 after treatment
Time frame: 3-21 months
Incidence of adverse events in each group
Time frame: 0-21 months
Complete remission rate at months 3, 6, 9, 12, 15, 18, and 21 after treatment
Time frame: 3-21 months
Partial remission rate at months 3, 6, 9, 12, 15, 18, and 21 after treatment
Time frame: 3-21 months
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 26 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telitacicept, Prednisone and Cyclophosphamide in people with Primary Membranous Nephropathy, run by Renmin Hospital of Wuhan University at 1 site 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 12 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: opening soon, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
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 Huiming Wang, PhD (+86 18971563100, rm000301@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate at the end of follow-up (21 months post-treatment) (time frame: 21 months). The study lists 2 primary outcomes in all. 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 26 Sep 2024.