Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN)Phase 1/2TEST-T-AAGNNCT06656962
The Efficacy and Safety of Treatment with Telitacicept in Antineutrophil Cytoplasmic Antibody-associated Nephritis (AAGN)
A Phase 1/2 study testing Telitacicept 160mg, Prednisone (and methylprednisolone) and Cyclophosphamide in people with Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN), run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
This study is a prospective, single-arm, open-label exploratory clinical study conducted in subjects with ANCA-associated nephritis (AAGN), aiming to evaluate the efficacy and safety of Telitacicept in the treatment of AAGN. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN)
- What is being tested?
- Telitacicept 160mg, Prednisone (and methylprednisolone) and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 30 Oct 2026
- Phase
- Phase 1/2
- 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
- Age ≥ 18 years and ≤ 75 years, both male and female are included.
- Clinically diagnosed as granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the definition of the 2012 Chapel Hill Consensus Conference (CHCC).
- Positive serological detection of autoantibodies, defined as follows: positive anti-proteinase 3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) (previous or screening test results).
- Renal involvement at screening, defined as at least one of the following: (1) At least one renal item in the Birmingham Vasculitis Activity Score (BVAS) version 3.0; (2) According to the pathological classification criteria formulated by the European Vasculitis Society (EUVAS) in 2003, there is active, biopsy-confirmed ANCA-associated nephritis (biopsy must be performed within 1 year before the screening visit or during the screening period); (3) Microscopic examination of urine shows red blood cell casts.
- Voluntarily participate in this clinical trial and sign the informed consent form.
Who cannot join
- Life-threatening severe vasculitis (including diffuse alveolar hemorrhage, respiratory failure, intestinal perforation or massive bleeding, cerebral vasculitis, cardiac vasculitis, etc.).
- Secondary vasculitis (such as systemic lupus erythematosus, Henoch-Schönlein purpura, drugs, tumors, infections, primary immunodeficiency, etc.).
- Patients with primary kidney diseases (such as IgA nephropathy, membranous nephropathy and anti-glomerular basement membrane nephritis, etc.).
- Major or uncontrolled diseases unrelated to AAV.
- Rapidly progressive glomerulonephritis with rapid decline in renal function: estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m² before the first administration, or already receiving continuous dialysis treatment.
- Patients with central nervous system diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).
Show all 20Show fewer
- Other multisystem autoimmune diseases including systemic lupus erythematosus, IgA, rheumatoid vasculitis, anti-glomerular basement membrane disease, cryoglobulinemic vasculitis, etc.
- Active hepatitis or a history of severe liver disease or liver lesions (HBsAg positive, or HBcAb positive and HBV-DNA positive), active pulmonary tuberculosis.
- Immunodeficiency, uncontrolled severe infection.
- Abnormal laboratory indicators that need to exclude subjects include but are not limited to the following indicators: total bilirubin ≥ 3 times the upper limit of normal, alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal, aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal, white blood cell (WBC) < 2.5×109/L, hemoglobin (Hb) < 85 g/L, platelet count (PLT) < 50×109/L.
- Received any of the following treatments within 364 days before day 0: a) B-cell targeted therapy (e.g., rituximab, other anti-CD20 drugs, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS receptor fusion protein [BR3], TACI-Fc); b) abatacept; c) experimental biological products.
- Patients who have undergone kidney transplantation or other organ transplantation.
- Received intravenous immunoglobulin or plasma exchange within 4 weeks before the first administration.
- Pregnant women, lactating women and men or women with plans for childbearing during the trial.
- Participated in other new drug clinical trials within 3 months before the first administration.
- Psychiatric patients with depression or suicidal thoughts.
- Have a history of major organ (such as heart, lung, kidney, liver) transplantation or hematopoietic stem cell/bone marrow transplantation or plan to receive transplantation.
- Those with positive test results within 4 weeks before screening suggesting COVID-19 infection, or those with a severe history of COVID-19 requiring hospitalization within 12 months before screening.
- Those allergic to Telitacicept.
- Other diseases or conditions that the investigator deems inappropriate for participation in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renmin Hospital of Wuhan University
This study is a prospective, single-arm, open-label exploratory clinical study conducted in subjects with ANCA-associated nephritis (AAGN), aiming to evaluate the efficacy and safety of Telitacicept in the treatment of AAGN.
- Being tested
- Telitacicept 160mg, Prednisone (and methylprednisolone), Cyclophosphamide
- Keywords
- ANCA-associated nephritis, ANCA, Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, AAGN
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telitacicept 160mgDrug
Also called Prednisone, Cyclophosphamide
Telitacicept for Injection combined with standard therapy (Prednisone and Cyclophosphamide) for the treatment of ANCA-associated nephritis (AAGN).
Prednisone (and methylprednisolone)Drug
Methylprednisone shock therapy (500mg, 3 times), followed by Prednisone (1 mg·kg·d and a pre-determined tapering guideline [PEXIVAS regimen]).
CyclophosphamideDrug
Cyclophosphamide, intravenous injection, once every 2 to 3 weeks, 0.75 g/m² each time, the maximum cumulative dose of 8g
| Study group | Role | What they receive |
|---|---|---|
| The Telitacicept treatment group | Experimental | Not described Receives: Drug: Telitacicept 160mg; Drug: Prednisone (and methylprednisolone); Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete remission rate of AAGN
The complete remission of AAGN is defined as no manifestations of glomerulonephritis (the renal item score of Birmingham vasculitis activity score [BVAS] is 0); the renal item score of BVAS can range from 0 to 58.
Measured: 24 weeks
The partial remission rate of AAGN
The partial remission refers to no active urinary sediment, stable or decreased Scr level, or a reduction of more than 50% in the renal item score of Birmingham vasculitis activity score [BVAS]; the renal item score of BVAS can range from 0 to 58.
Measured: 24 weeks
Secondary outcomes (3)
The complete remission rate of ANCA
The changes of Birmingham vasculitis activity score (BVAS) relative to baseline were calculated, and the proportion of subjects who achieved complete response (BVAS=0); when calculating the total BVAS score, the maximum score for each organ is 12, the total scores can range from 0 to 63.
Measured: 24 weeks
The partial remission rate of ANCA
The partial response (BVAS score decreased by more than 50%) was calculated. The Birmingham Vasculitis Activity Score (BVAS): when calculating the total BVAS score, the maximum score for each organ is 12, the total scores can range from 0 to 63.
Measured: 24 weeks
Safety and tolerability of patients, occurrence and recurrence of adverse events during the trial
This trial specifies that the recording of adverse events shall be recorded as a medical history from the time the subject receives the 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: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start10 Oct 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
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
- NCT06656962
- Sponsor's protocol ID
- RCTAIIRANCA001
- Acronym
- TEST-T-AAGN
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renmin Hospital of Wuhan University
- ClinicalTrials.gov ID
- NCT06656962
- Acronym / sponsor ID
- TEST-T-AAGN / RCTAIIRANCA001
- Keywords
- ANCA-associated nephritis, ANCA, Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, AAGN
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 24 Oct 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 study is a prospective, single-arm, open-label exploratory clinical study conducted in subjects with ANCA-associated nephritis (AAGN), aiming to evaluate the efficacy and safety of Telitacicept in the treatment of AAGN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Telitacicept treatment group | Experimental | Drug: Telitacicept 160mg, Drug: Prednisone (and methylprednisolone), Drug: Cyclophosphamide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years and ≤ 75 years, both male and female are included.
- Clinically diagnosed as granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the definition of the 2012 Chapel Hill Consensus Conference (CHCC).
- Positive serological detection of autoantibodies, defined as follows: positive anti-proteinase 3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) (previous or screening test results).
- Renal involvement at screening, defined as at least one of the following: (1) At least one renal item in the Birmingham Vasculitis Activity Score (BVAS) version 3.0; (2) According to the pathological classification criteria formulated by the European Vasculitis Society (EUVAS) in 2003, there is active, biopsy-confirmed ANCA-associated nephritis (biopsy must be performed within 1 year before the screening visit or during the screening period); (3) Microscopic examination of urine shows red blood cell casts.
- Voluntarily participate in this clinical trial and sign the informed consent form.
Key exclusion criteria (20 listed)
- Life-threatening severe vasculitis (including diffuse alveolar hemorrhage, respiratory failure, intestinal perforation or massive bleeding, cerebral vasculitis, cardiac vasculitis, etc.).
- Secondary vasculitis (such as systemic lupus erythematosus, Henoch-Schönlein purpura, drugs, tumors, infections, primary immunodeficiency, etc.).
- Patients with primary kidney diseases (such as IgA nephropathy, membranous nephropathy and anti-glomerular basement membrane nephritis, etc.).
- Major or uncontrolled diseases unrelated to AAV.
- Rapidly progressive glomerulonephritis with rapid decline in renal function: estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m² before the first administration, or already receiving continuous dialysis treatment.
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 |
|---|---|---|
| Telitacicept 160mgAlso: Prednisone, CyclophosphamideTelitacicept for Injection combined with standard therapy (Prednisone and Cyclophosphamide) for the treatment of ANCA-associated nephritis (AAGN). | Drug | The Telitacicept treatment group |
| Prednisone (and methylprednisolone)Methylprednisone shock therapy (500mg, 3 times), followed by Prednisone (1 mg·kg·d and a pre-determined tapering guideline [PEXIVAS regimen]). | Drug | The Telitacicept treatment group |
| CyclophosphamideCyclophosphamide, intravenous injection, once every 2 to 3 weeks, 0.75 g/m² each time, the maximum cumulative dose of 8g | Drug | The Telitacicept treatment group |
Primary outcome
The complete remission rate of AAGN
Time frame: 24 weeks
The complete remission of AAGN is defined as no manifestations of glomerulonephritis (the renal item score of Birmingham vasculitis activity score [BVAS] is 0); the renal item score of BVAS can range from 0 to 58.
The partial remission rate of AAGN
Time frame: 24 weeks
The partial remission refers to no active urinary sediment, stable or decreased Scr level, or a reduction of more than 50% in the renal item score of Birmingham vasculitis activity score [BVAS]; the renal item score of BVAS can range from 0 to 58.
3 secondary outcomes
The complete remission rate of ANCA
Time frame: 24 weeks
The partial remission rate of ANCA
Time frame: 24 weeks
Safety and tolerability of patients, occurrence and recurrence of adverse events during the trial
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN)
Not yet recruitingEarly Phase 1
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
IgA Nephropathy (IgAN), 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Telitacicept 160mg, Prednisone (and methylprednisolone) and Cyclophosphamide in people with Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN), 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 20 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 24 Oct 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The complete remission rate of AAGN (time frame: 24 weeks). 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 24 Oct 2024.