IgA Nephropathy (IgAN)NCT06654596
Efficacy and Safety of Telitacicept in IgAN
A study testing Telitacicept 240mg and Glucocorticoid in people with IgA Nephropathy (IgAN) and Kidney Diseases, run by Ruijin Hospital at 1 site in China.
Trial summary
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IgA Nephropathy (IgAN), Kidney Diseases, Telitacicept
- What is being tested?
- Telitacicept 240mg and Glucocorticoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2024to Dec 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old, male or female
- Primary IgA nephropathy confirmed by renal biopsy.
- Urine protein ≥ 0.75g/24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g/g.
- eGFR ≥ 25 ml/min/1.73 m2 calculated using the CKD-EPI formula.
- Received treatment with ACEI/ARB for 12 weeks before randomization, and the drug dose (within the maximum tolerated range) was stable within 4 weeks before randomization.
- Use of SGLT2, MRA, hydroxychloroquine, and etc. remained unchanged.
- Voluntarily participated in this study and signed the informed consent form.
Who cannot join
- Patients with abnormal laboratory indicators (see study protocol for details).
- Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.
- Use of systemic glucocorticoids/immunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.).
- Use of biological agents within 6 months (rituximab, etc.).
- Active infection, such as active tuberculosis, active hepatitis, hepatitis C, herpes zoster, HIV, etc. According to the results of the five hepatitis B test: patients with positive HBsAg should be excluded; patients with negative HBsAg but positive HBcAb, regardless of whether HBsAb is positive or negative, need to test HBV-DNA to determine their situation: if HBV-DNA is positive, the patient needs to be excluded; if HBV-DNA is negative, the patient can participate in the trial.
- COVID-19 infection within 2 weeks before randomization.
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- Live vaccine within 4 weeks before randomization.
- History of malignant tumor within five years.
- Uncontrolled hypertension (systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg).
- Poorly controlled diabetes (glycosylated hemoglobin>8%).
- Pregnant women and breastfeeding women.
- Participating in other clinical trials at the same time.
- Surgery, chemotherapy, radiotherapy and other treatments are planned during the study.
- Other reasons judged by researchers as unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, 200025
Jieming Qu, +86-021-64370045, partyoffice@rjh.com.cn
About this study
Official title: A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.
Read the detailed description
IgA nephropathy is a glomerulonephritis characterized by pathological IgA deposition in the mesangial region. Its clinical and pathological manifestations are diverse and heterogeneous. Its pathogenesis has not yet been fully clarified, and there is currently no unified treatment plan. As a recombinant human B lymphocyte stimulator receptor-antibody fusion protein, telitacicept has become a new therapeutic target. The results of the Phase II clinical trial of this drug for IgA nephropathy have already been published. It is one of the key pioneering clinical studies in the field of IgA nephropathy treatment. The study showed that telitacicept can effectively reduce patients' proteinuria and reduce the risk of disease progression. Based on the above research results, the investigators plan to conduct a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of telitacicept in the treatment of primary IgA nephropathy patients with a high risk of progression.
- Conditions
- IgA Nephropathy (IgAN), Kidney Diseases, Telitacicept, Glucocorticoid
- Being tested
- Telitacicept 240mg, Glucocorticoid
- Medical subject headings
- Glomerulonephritis, IGA, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telitacicept 240mgDrug
Patients in telitacicept group will be treated with maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and/or angiotensin II receptor blocker ( ARB ) combined with telitacicept. 240 mg telitacicept will be used once a week for 40 weeks.
GlucocorticoidDrug
Patients in glucocorticoid group will be treated with ACEI/ARB and glucocorticoid ( prednisone/prednisolone) 0.5mg/kg (maximum 40mg/d). After 8 weeks, reduce the dosage by 5 mg per month for a total of 28-40 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept+ACEI/ARB | Experimental | Not described Receives: Drug: Telitacicept 240mg |
| Glucocorticoids+ACEI/ARB | Active comparator | Not described Receives: Drug: Glucocorticoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 24-hour urine protein
Change of 24-hour urine protein from baseline to week 40
Measured: From baseline to week 40
Secondary outcomes (8)
Change of PCR
Change of 24-hour urine protein creatinine ratio (PCR) from baseline to week 40
Measured: From baseline to week 40
Annualized eGFR slope
Annualized eGFR slope from baseline to week 40
Measured: From baseline to week 40
Change of eGFR
Change of eGFR from baseline to week 40
Measured: From baseline to week 40
Proportion of patients with a decrease in eGFR ≥30%
Proportion of patients with a decrease in eGFR ≥30% from baseline to week 40
Measured: From baseline to week 40
Proportion of patients with a decrease in eGFR ≥40%
Proportion of patients with a decrease in eGFR ≥40% from baseline to week 40
Measured: From baseline to week 40
Change of 24-hour urine ACR
Change of 24-hour urine albumin creatinine ratio (ACR) from baseline to week 40
Measured: From baseline to week 40
Proportion of patients achieving 24-hour urine PCR < 0.6 g/g
Proportion of patients achieving 24-hour urine PCR < 0.6 g/g from baseline to week 40
Measured: From baseline to week 40
Time from the first use of treatment to the occurrence of a composite endpoint event
Time from the first use of treatment to the occurrence of a composite endpoint event. The composite endpoint event was defined as: the time from the first use of treatment to the first decrease in eGFR from baseline by ≥30% or ≥40% (at least 4 weeks), initiation of maintenance renal dialysis (at least 4 weeks), eGFR <15 mL/min/1.73m2 (at least 4 weeks), renal transplantation, or death due to renal failure.
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start6 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital, Sichuan Provincial People's Hospital, Renmin Hospital of Wuhan University, Shanghai 6th People's Hospital, Shanghai Longhua Hospital, Huashan Hospital, Shanghai Changzheng Hospital, Wannan Medical College Yijishan Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine
- Responsible party
- Principal investigator, Xie Jingyuan, MD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654596
- Sponsor's protocol ID
- TETA-IgA
- Status last verified
- Dec 2024
- First submitted
- 18 Oct 2024
- Last updated
- 1 Jan 2025
- 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 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy
- ClinicalTrials.gov ID
- NCT06654596
- Acronym / sponsor ID
- TETA-IgA
- Conditions
- IgA Nephropathy (IgAN), Kidney Diseases, Telitacicept, Glucocorticoid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital, Sichuan Provincial People's Hospital, Renmin Hospital of Wuhan University, Shanghai 6th People's Hospital, Shanghai Longhua Hospital, Huashan Hospital, Shanghai Changzheng Hospital, Wannan Medical College Yijishan Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 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.
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.
Detailed description
IgA nephropathy is a glomerulonephritis characterized by pathological IgA deposition in the mesangial region. Its clinical and pathological manifestations are diverse and heterogeneous. Its pathogenesis has not yet been fully clarified, and there is currently no unified treatment plan. As a recombinant human B lymphocyte stimulator receptor-antibody fusion protein, telitacicept has become a new therapeutic target. The results of the Phase II clinical trial of this drug for IgA nephropathy have already been published. It is one of the key pioneering clinical studies in the field of IgA nephropathy treatment. The study showed that telitacicept can effectively reduce patients' proteinuria and reduce the risk of disease progression. Based on the above research results, the investigators plan to conduct a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of telitacicept in the treatment of primary IgA nephropathy patients with a high risk of progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telitacicept+ACEI/ARB | Experimental | Drug: Telitacicept 240mg |
| Glucocorticoids+ACEI/ARB | Active comparator | Drug: Glucocorticoid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-70 years old, male or female
- Primary IgA nephropathy confirmed by renal biopsy.
- Urine protein ≥ 0.75g/24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g/g.
- eGFR ≥ 25 ml/min/1.73 m2 calculated using the CKD-EPI formula.
- Received treatment with ACEI/ARB for 12 weeks before randomization, and the drug dose (within the maximum tolerated range) was stable within 4 weeks before randomization.
Key exclusion criteria (14 listed)
- Patients with abnormal laboratory indicators (see study protocol for details).
- Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.
- Use of systemic glucocorticoids/immunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.).
- Use of biological agents within 6 months (rituximab, etc.).
- Active infection, such as active tuberculosis, active hepatitis, hepatitis C, herpes zoster, HIV, etc. According to the results of the five hepatitis B test: patients with positive HBsAg should be excluded; patients with negative HBsAg but positive HBcAb, regardless of whether HBsAb is positive or negative, need to test HBV-DNA to determine their situation: if HBV-DNA is positive, the patient needs to be excluded; if HBV-DNA is negative, the patient can participate in the trial.
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 240mgPatients in telitacicept group will be treated with maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and/or angiotensin II receptor blocker ( ARB ) combined with telitacicept. 240 mg telitacicept will be used once a week for 40 weeks. | Drug | Telitacicept+ACEI/ARB |
| GlucocorticoidPatients in glucocorticoid group will be treated with ACEI/ARB and glucocorticoid ( prednisone/prednisolone) 0.5mg/kg (maximum 40mg/d). After 8 weeks, reduce the dosage by 5 mg per month for a total of 28-40 weeks. | Drug | Glucocorticoids+ACEI/ARB |
Primary outcome
Change of 24-hour urine protein
Time frame: From baseline to week 40
Change of 24-hour urine protein from baseline to week 40
8 secondary outcomes
Change of PCR
Time frame: From baseline to week 40
Annualized eGFR slope
Time frame: From baseline to week 40
Change of eGFR
Time frame: From baseline to week 40
Proportion of patients with a decrease in eGFR ≥30%
Time frame: From baseline to week 40
Proportion of patients with a decrease in eGFR ≥40%
Time frame: From baseline to week 40
Change of 24-hour urine ACR
Time frame: From baseline to week 40
Proportion of patients achieving 24-hour urine PCR < 0.6 g/g
Time frame: From baseline to week 40
Time from the first use of treatment to the occurrence of a composite endpoint event
Time frame: Up to 40 weeks
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 1 Jan 2025.
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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 study testing Telitacicept 240mg and Glucocorticoid in people with IgA Nephropathy (IgAN) and Kidney Diseases, run by Ruijin Hospital 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 7 inclusion and 14 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 1 Jan 2025. 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.
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 Jingyuan Xie (+86-64370045 ext. 665232, nephroxie@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 24-hour urine protein (time frame: From baseline to week 40). 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 1 Jan 2025.