IgA NephropathyPhase 2/3NCT05596708
Study of Telitacicept in Patients With Refractory IgA Nephropathy
A Phase 2/3 study testing Telitacicept in people with IgA Nephropathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy. The main questions it aims to answer are: To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Telitacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Sep 2026
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form.
- IgA nephropathy was confirmed by pathological biopsy.
- Age range: ≥ 18 years old, ≤ 70 years old, male or female.
- During the screening period, the 24-hour urine protein of Visit 1 and Visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at Visit 3.
- Measured glomerular filtration rate or estimated GFR (using the CKD-EPI formula) > 35 mL/min/1.73 m2.
- Participants had received a basic regimen including ACE inhibitors/ARBs for 12 weeks prior to randomization, and the dose of ACE inhibitors/ARBs (within the maximum tolerated range) was stable for 4 weeks prior to randomization.
Who cannot join
- Abnormal laboratory indicators of participants need to be excluded.
- Secondary IgA nephropathy need to be excluded.
- Specific pathologic or clinical renal disease types, and IgA nephropathy that may require hormone therapy.
- Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening.
- Use of systemic corticosteroids within 3 months prior to randomization (except local, nasal inhalation, etc.)
- Immunosuppressants were used within 3 months prior to randomization.
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- Patients requiring hospitalization for active infection or intravenous anti-infective therapy within 3 months prior to randomization.
- Previously or currently diagnosed active tuberculosis Untreated latent tuberculosis.
- Herpes zoster HIV antibody positive or HCV antibody positive during the screening period.
- Those who currently have active hepatitis or have severe liver disease and medical history.
- Patients with malignant tumors.
- Pregnant and lactating women, and men or women with planned children during the trial period.
- Those who could not avoid the use of nephrotoxic drugs during the trial.
- Allergic to human biological products.
- Patients who have been given any of the clinical trial drugs 4 weeks prior to randomization or within 5 times the half-life of the experimental drug (whichever is longer).
- Patients deemed ineligible for the trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Ma Kunling, PhD, 15150515798, klma@zju.edu.cn
About this study
Official title: A Single-arm, Forward-looking, Exploratory Clinical Study of Telitacicept in Patients With Refractory IgA Nephropathy
The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy.
The main questions it aims to answer are:
- To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy.
- To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy.
Participants will be subcutaneously injected with 240mg of Telitacicept once per week.
Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.
- Conditions
- IgA Nephropathy
- Being tested
- Telitacicept
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for 104 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept treated group | Experimental | Not described Receives: Drug: Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical response
- Proteinuria: protein-to-creatinine ratio <0.2; b. Stable renal function: eGFR decreased by less than 5ml/min/1.73m2 from baseline at the end of the 3-year trial phase.
Measured: 3-year
The absolute value of eGFR
The absolute value of eGFR decreased by more than 15 ml/min/1.73m2 over 3 years from baseline
Measured: 3-year
Changes in 24-hour urinary protein
Changes in 24-hour urinary protein at week 104 compared with baseline.
Measured: 104 weeks
Secondary outcomes (2)
eGFR decrease
The estimated glomerular filtration rate (eGFR) decreased by more than 30 ml/min/1.73 m2 from baseline.
Measured: 3-year
Need for dialysis
progression to end-stage renal disease
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Mar 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596708
- Sponsor's protocol ID
- SZNK
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 24 Feb 2023
- 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 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Forward-looking, Exploratory Clinical Study of Telitacicept in Patients With Refractory IgA Nephropathy
- ClinicalTrials.gov ID
- NCT05596708
- Acronym / sponsor ID
- SZNK
- Conditions
- IgA Nephropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Oct 2022 (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 goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy.
The main questions it aims to answer are:
- To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy.
- To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy.
Participants will be subcutaneously injected with 240mg of Telitacicept once per week.
Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telitacicept treated group | Experimental | Drug: Telitacicept |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily sign the informed consent form.
- IgA nephropathy was confirmed by pathological biopsy.
- Age range: ≥ 18 years old, ≤ 70 years old, male or female.
- During the screening period, the 24-hour urine protein of Visit 1 and Visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at Visit 3.
- Measured glomerular filtration rate or estimated GFR (using the CKD-EPI formula) > 35 mL/min/1.73 m2.
Key exclusion criteria (16 listed)
- Abnormal laboratory indicators of participants need to be excluded.
- Secondary IgA nephropathy need to be excluded.
- Specific pathologic or clinical renal disease types, and IgA nephropathy that may require hormone therapy.
- Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening.
- Use of systemic corticosteroids within 3 months prior to randomization (except local, nasal inhalation, etc.)
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 |
|---|---|---|
| TelitaciceptTelitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for 104 weeks. | Drug | Telitacicept treated group |
Primary outcome
Complete clinical response
Time frame: 3-year
a. Proteinuria: protein-to-creatinine ratio <0.2; b. Stable renal function: eGFR decreased by less than 5ml/min/1.73m2 from baseline at the end of the 3-year trial phase.
The absolute value of eGFR
Time frame: 3-year
The absolute value of eGFR decreased by more than 15 ml/min/1.73m2 over 3 years from baseline
Changes in 24-hour urinary protein
Time frame: 104 weeks
Changes in 24-hour urinary protein at week 104 compared with baseline.
2 secondary outcomes
eGFR decrease
Time frame: 3-year
Need for dialysis
Time frame: 3-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- 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. This study is not recruiting at the moment.
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Telitacicept in people with IgA Nephropathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 16 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 Feb 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clinical response (time frame: 3-year). The study lists 3 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 Feb 2023.