Nephrotic Syndrome in ChildrenPhase 3STERNNCT06125405
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
A Phase 3 study testing Telitacicept in people with Nephrotic Syndrome in Children and Telitacicept, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The main objective is to evaluate the effectiveness of telitacicept in pediatric patients with frequently relapsing or steroid dependent nephrotic syndrome within the 52-week follow-up. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Nephrotic Syndrome in Children, Telitacicept
- 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2023to 24 Oct 2027
- Phase
- Phase 3
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Sensitive but frequent relapses or steroids dependence nephrotic syndrome
- Age: 2 to 18 years old
- Normal renal function: estimated glomerular filtration rate ≥90ml/ min/1.73m2
- Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/ mmol) for 3 consecutive days and above when in enroll
- No rituximab was used within 6 months, no tacrolimus, mycophenolate mofetil, cyclosporine A, or cyclophosphamide was used within 3 months, no ACTH was used within 3 months prior to the enrollment
Who cannot join
- Family history of nephrotic syndrome, chronic glomerulonephritis or uremia
- Leukopenia (White Blood Cells ≤ 3.0 * 10^9 / L)
- Moderate to severe anemia (hemoglobin <9.0 g/dL)
- Thrombocytopenia (platelet count <100*10^12/L)
- Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or / and Hepatitis B virus e antigen or / and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks)
- There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents may aggravate the state of an illness
Show all 11Show fewer
- Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.)
- Those who with hematological or endocrine system diseases as well as serious organs illness such as heart, liver or kidney
- Those who with other autoimmune diseases or primary immunodeficiencies or tumors
- Those who have participated in other clinical trials within three months prior to the enrollment
- Those who was not suitable for participating this study judged by investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chunyue Feng contact
China1 site, 1 recruiting
- Recruiting
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jianhua Mao, MD, 13616819071, maojh88@zju.edu.cn
About this study
The main objective is to evaluate the effectiveness of telitacicept in pediatric patients with frequently relapsing or steroid dependent nephrotic syndrome within the 52-week follow-up.
Read the detailed description
Nephrotic syndrome(NS) is the most common glomerular disease in children. Approximately 45-50% of patients with nephrotic syndrome exhibit frequent relapses or are dependent on steroid therapy. Frequent relapses or steroid dependence in nephrotic syndrome have been challenging issues for clinicians. Long-term, repeated, and high-dose oral steroid use can lead to side effects such as obesity, delayed development, hypertension, diabetes, glaucoma, osteoporosis, and increased susceptibility to infections. The addition of traditional immunosuppressants such as cyclophosphamide and tacrolimus can cause severe and irreversible side effects. Therefore, exploring new drugs and their application protocols is particularly important. Telitacicept has a unique dual-target mechanism that can inhibit B cell maturation and differentiation at multiple stages, thereby inhibiting B cell activity. Clinical studies have confirmed its significant efficacy in various kidney diseases, such as lupus nephritis, IgA nephropathy, and adult recurrent minimal change nephrotic syndrome; moreover, it has good safety profiles.
Therefore, through this prospective, single-center, open-label clinical trial, we aim to evaluate whether telitacicept provides superior efficacy compared to existing conventional treatment regimens for childhood frequent relapse (FR) or steroid-dependent (SD) nephrotic syndrome (NS), and assess its safety profile. Our goal is to provide an optimized treatment plan for childhood FRNS or SDNS.
- Conditions
- Nephrotic Syndrome in Children, Telitacicept
- Being tested
- Telitacicept
- Keywords
- Telitacicept, Frequently Relapsing Nephrotic Syndrome, Steroid Dependent Nephrotic Syndrome
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
The study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept group | Experimental | Weekly administration (administration time can be within 1 week + 3 days). Body weight and dosage: for subjects with body weight greater than 10kg and less than or equal to 20kg, the dose of Telitacicept is 40mg; for subjects with body weight greater than 20kg and less than or equal to 40kg, the dose of Telitacicept is 80mg; for subjects with body weight greater than 40kg and less than or equal to 60kg, the dose of Telitacicept is 120mg; for subjects with body weight greater than or equal to 60kg, the dose of Telitacicept is 160mg. Treatment duration: 52 weeks. Receives: Drug: Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year relapse-free survival rate
The rate of no relapse within 1 year
Measured: 1-year period after enrollment
Secondary outcomes (8)
Relapse of nephrotic syndrome during 12 months after enrollment
Proportion of patients with one or more relapse(s) of nephrotic syndrome
Measured: 1-year period after enrollment
Number of relapses during 12 months follow up
Number of nephrotic syndrome relapses per patient year during the 12 months period after enrollment
Measured: 1-year period after enrollment
The first time to relapse
The first time to relapse after patients taking part in this study
Measured: 1-year period after enrollment
Cumulative prednisone dosage (milligrams per kilogram per year)
The total dosage of prednisones from the beginning to the end of the trial
Measured: 1-year period after enrollment
Change in hemoglobin of the patients
The changes of hemoglobin (g/L) in each follow-up during the study
Measured: 1-year period after enrollment
Change in blood albumin of the patients
The changes of blood albumin (g/L）in each follow-up during the study
Measured: 1-year period after enrollment
Change in renal function of the patients
The change for renal function was judged by the changes of estimated glomerular filtration rate (eGFR in ml/min/1.73m^2) in each follow-up during the study
Measured: 1-year period after enrollment
Change in mass index (BMI) during 12-month period after enrollment
Changes in standard deviation scores for weight (Wt in kilograms), height (Ht in meters) will be combined to report body mass index (BMI in kg/m^2) during 12-month period after enrollment
Measured: 1-year period after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start28 Nov 2023
- Primary completion24 Oct 2026 (estimated)
- Study completion24 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nephrotic Syndrome in ChildrenStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Jianhua Mao, MD, Principal investigator, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125405
- Sponsor's protocol ID
- STERN
- Acronym
- STERN
- Status last verified
- Aug 2024
- First submitted
- 24 Oct 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Veltkamp F, Rensma LR, Bouts AHM; LEARNS consortium. Incidence and Relapse of Idiopathic Nephrotic Syndrome: Meta-analysis. Pediatrics. 2021 Jul;148(1):e2020029249. doi: 10.1542/peds.2020-029249. Epub 2021 Jun 30.
PubMed 34193618Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003 Aug 23;362(9384):629-39. doi: 10.1016/S0140-6736(03)14184-0.
PubMed 12944064Filler G, Young E, Geier P, Carpenter B, Drukker A, Feber J. Is there really an increase in non-minimal change nephrotic syndrome in children? Am J Kidney Dis. 2003 Dec;42(6):1107-13. doi: 10.1053/j.ajkd.2003.08.010.
PubMed 14655180Tarshish P, Tobin JN, Bernstein J, Edelmann CM Jr. Prognostic significance of the early course of minimal change nephrotic syndrome: report of the International Study of Kidney Disease in Children. J Am Soc Nephrol. 1997 May;8(5):769-76. doi: 10.1681/ASN.V85769.
PubMed 9176846Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep;81(14):1671-1675. doi: 10.1007/s40265-021-01591-1.
PubMed 34463932Shi F, Xue R, Zhou X, Shen P, Wang S, Yang Y. Telitacicept as a BLyS/APRIL dual inhibitor for autoimmune disease. Immunopharmacol Immunotoxicol. 2021 Dec;43(6):666-673. doi: 10.1080/08923973.2021.1973493. Epub 2021 Sep 14.
PubMed 34519594Cai J, Gao D, Liu D, Liu Z. Telitacicept for autoimmune nephropathy. Front Immunol. 2023 Jun 5;14:1169084. doi: 10.3389/fimmu.2023.1169084. eCollection 2023.
PubMed 37342346Chen R, Fu R, Lin Z, Huang C, Huang W. The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study. Lupus. 2023 Jan;32(1):94-100. doi: 10.1177/09612033221141253. Epub 2022 Nov 23.
PubMed 36416639Lv J, Liu L, Hao C, Li G, Fu P, Xing G, Zheng H, Chen N, Wang C, Luo P, Xie D, Zuo L, Li R, Mao Y, Dong S, Zhang P, Zheng H, Wang Y, Qin W, Wang W, Li L, Jiao W, Fang J, Zhang H. Randomized Phase 2 Trial of Telitacicept in Patients With IgA Nephropathy With Persistent Proteinuria. Kidney Int Rep. 2022 Dec 29;8(3):499-506. doi: 10.1016/j.ekir.2022.12.014. eCollection 2023 Mar.
PubMed 36938094Li S, Ding L, Yang YJ, Yang XD. Telitacicept for minimal change disease. Kaohsiung J Med Sci. 2023 Jul;39(7):748-749. doi: 10.1002/kjm2.12719. No abstract available.
PubMed 37440467
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT06125405
- Acronym / sponsor ID
- STERN / STERN
- Conditions
- Nephrotic Syndrome in Children, Telitacicept
- Keywords
- Telitacicept, Frequently Relapsing Nephrotic Syndrome, Steroid Dependent Nephrotic Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 24 Oct 2026 (estimated)
- Study completion
- 24 Oct 2027 (estimated)
- First posted
- 9 Nov 2023 (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 main objective is to evaluate the effectiveness of telitacicept in pediatric patients with frequently relapsing or steroid dependent nephrotic syndrome within the 52-week follow-up.
Detailed description
Nephrotic syndrome(NS) is the most common glomerular disease in children. Approximately 45-50% of patients with nephrotic syndrome exhibit frequent relapses or are dependent on steroid therapy. Frequent relapses or steroid dependence in nephrotic syndrome have been challenging issues for clinicians. Long-term, repeated, and high-dose oral steroid use can lead to side effects such as obesity, delayed development, hypertension, diabetes, glaucoma, osteoporosis, and increased susceptibility to infections. The addition of traditional immunosuppressants such as cyclophosphamide and tacrolimus can cause severe and irreversible side effects. Therefore, exploring new drugs and their application protocols is particularly important. Telitacicept has a unique dual-target mechanism that can inhibit B cell maturation and differentiation at multiple stages, thereby inhibiting B cell activity. Clinical studies have confirmed its significant efficacy in various kidney diseases, such as lupus nephritis, IgA nephropathy, and adult recurrent minimal change nephrotic syndrome; moreover, it has good safety profiles.
Therefore, through this prospective, single-center, open-label clinical trial, we aim to evaluate whether telitacicept provides superior efficacy compared to existing conventional treatment regimens for childhood frequent relapse (FR) or steroid-dependent (SD) nephrotic syndrome (NS), and assess its safety profile. Our goal is to provide an optimized treatment plan for childhood FRNS or SDNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telitacicept group | Experimental | Drug: TelitaciceptWeekly administration (administration time can be within 1 week + 3 days). Body weight and dosage: for subjects with body weight greater than 10kg and less than or equal to 20kg, the dose of Telitacicept is 40mg; for subjects with body weight greater than 20kg and less than or equal to 40kg, the dose of Telitacicept is 80mg; for subjects with body weight greater than 40kg and less than or equal to 60kg, the dose of Telitacicept is 120mg; for subjects with body weight greater than or equal to 60kg, the dose of Telitacicept is 160mg. Treatment duration: 52 weeks. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Sensitive but frequent relapses or steroids dependence nephrotic syndrome
- Age: 2 to 18 years old
- Normal renal function: estimated glomerular filtration rate ≥90ml/ min/1.73m2
- Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/ mmol) for 3 consecutive days and above when in enroll
- No rituximab was used within 6 months, no tacrolimus, mycophenolate mofetil, cyclosporine A, or cyclophosphamide was used within 3 months, no ACTH was used within 3 months prior to the enrollment
Key exclusion criteria (11 listed)
- Family history of nephrotic syndrome, chronic glomerulonephritis or uremia
- Leukopenia (White Blood Cells ≤ 3.0 * 10^9 / L)
- Moderate to severe anemia (hemoglobin <9.0 g/dL)
- Thrombocytopenia (platelet count <100*10^12/L)
- Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or / and Hepatitis B virus e antigen or / and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks)
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 |
|---|---|---|
| TelitaciceptThe study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks. | Drug | Telitacicept group |
Primary outcome
1-year relapse-free survival rate
Time frame: 1-year period after enrollment
The rate of no relapse within 1 year
8 secondary outcomes
Relapse of nephrotic syndrome during 12 months after enrollment
Time frame: 1-year period after enrollment
Number of relapses during 12 months follow up
Time frame: 1-year period after enrollment
The first time to relapse
Time frame: 1-year period after enrollment
Cumulative prednisone dosage (milligrams per kilogram per year)
Time frame: 1-year period after enrollment
Change in hemoglobin of the patients
Time frame: 1-year period after enrollment
Change in blood albumin of the patients
Time frame: 1-year period after enrollment
Change in renal function of the patients
Time frame: 1-year period after enrollment
Change in mass index (BMI) during 12-month period after enrollment
Time frame: 1-year period after enrollment
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 21 Aug 2024.
- Background: PubMed 34193618Veltkamp F, Rensma LR, Bouts AHM; LEARNS consortium. Incidence and Relapse of Idiopathic Nephrotic Syndrome: Meta-analysis. Pediatrics. 2021 Jul;148(1):e2020029249. doi: 10.1542/peds.2020-029249. Epub 2021 Jun 30.
- Background: PubMed 12944064Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003 Aug 23;362(9384):629-39. doi: 10.1016/S0140-6736(03)14184-0.
- Background: PubMed 14655180Filler G, Young E, Geier P, Carpenter B, Drukker A, Feber J. Is there really an increase in non-minimal change nephrotic syndrome in children? Am J Kidney Dis. 2003 Dec;42(6):1107-13. doi: 10.1053/j.ajkd.2003.08.010.
- Background: PubMed 9176846Tarshish P, Tobin JN, Bernstein J, Edelmann CM Jr. Prognostic significance of the early course of minimal change nephrotic syndrome: report of the International Study of Kidney Disease in Children. J Am Soc Nephrol. 1997 May;8(5):769-76. doi: 10.1681/ASN.V85769.
- Background: PubMed 34463932Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep;81(14):1671-1675. doi: 10.1007/s40265-021-01591-1.
- Background: PubMed 34519594Shi F, Xue R, Zhou X, Shen P, Wang S, Yang Y. Telitacicept as a BLyS/APRIL dual inhibitor for autoimmune disease. Immunopharmacol Immunotoxicol. 2021 Dec;43(6):666-673. doi: 10.1080/08923973.2021.1973493. Epub 2021 Sep 14.
- Background: PubMed 37342346Cai J, Gao D, Liu D, Liu Z. Telitacicept for autoimmune nephropathy. Front Immunol. 2023 Jun 5;14:1169084. doi: 10.3389/fimmu.2023.1169084. eCollection 2023.
- Background: PubMed 36416639Chen R, Fu R, Lin Z, Huang C, Huang W. The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study. Lupus. 2023 Jan;32(1):94-100. doi: 10.1177/09612033221141253. Epub 2022 Nov 23.
- Background: PubMed 36938094Lv J, Liu L, Hao C, Li G, Fu P, Xing G, Zheng H, Chen N, Wang C, Luo P, Xie D, Zuo L, Li R, Mao Y, Dong S, Zhang P, Zheng H, Wang Y, Qin W, Wang W, Li L, Jiao W, Fang J, Zhang H. Randomized Phase 2 Trial of Telitacicept in Patients With IgA Nephropathy With Persistent Proteinuria. Kidney Int Rep. 2022 Dec 29;8(3):499-506. doi: 10.1016/j.ekir.2022.12.014. eCollection 2023 Mar.
- Background: PubMed 37440467Li S, Ding L, Yang YJ, Yang XD. Telitacicept for minimal change disease. Kaohsiung J Med Sci. 2023 Jul;39(7):748-749. doi: 10.1002/kjm2.12719. No abstract available.
- Individual participant dataSharing planned: No
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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.
Chunyue Feng contact
Jianhua Mao, MD principal investigator
The Children's Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telitacicept in people with Nephrotic Syndrome in Children and Telitacicept, run by The Children's Hospital of 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 5 inclusion and 11 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 21 Aug 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 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?
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 Jianhua Mao, MD (86057186670015, maojh88@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year relapse-free survival rate (time frame: 1-year period after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06125405, which also lists 10 linked publications.
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 21 Aug 2024.