Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome

NCT06125405 | Recruiting Phase 3

• 1 other identifier: STERN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrotic Syndrome in Children; Telitacicept

Keywords

Telitacicept; Frequently Relapsing Nephrotic Syndrome; Steroid Dependent Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

• 1-year relapse-free survival rate

  The rate of no relapse within 1 year

  1-year period after enrollment

Secondary Outcomes (8)

• Relapse of nephrotic syndrome during 12 months after enrollment

  1-year period after enrollment

• Number of relapses during 12 months follow up

  1-year period after enrollment

• The first time to relapse

  1-year period after enrollment

• Cumulative prednisone dosage (milligrams per kilogram per year)

  1-year period after enrollment

• Change in hemoglobin of the patients

  1-year period after enrollment

Other Outcomes (1)

• Adverse event

  1-year period after enrollment

Study Arms (1)

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.

Drug: Telitacicept

Interventions

Telitacicept DRUG

The study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks.

Telitacicept group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 34193618 BACKGROUND

• Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003 Aug 23;362(9384):629-39. doi: 10.1016/S0140-6736(03)14184-0.

  PMID: 12944064 BACKGROUND

• Filler 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.

  PMID: 14655180 BACKGROUND

• Tarshish 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.

  PMID: 9176846 BACKGROUND

• Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep;81(14):1671-1675. doi: 10.1007/s40265-021-01591-1.

  PMID: 34463932 BACKGROUND

• Shi 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.

  PMID: 34519594 BACKGROUND

• Cai 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.

  PMID: 37342346 BACKGROUND

• Chen 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.

  PMID: 36416639 BACKGROUND

• Lv 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.

  PMID: 36938094 BACKGROUND

• Li 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.

  PMID: 37440467 BACKGROUND

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jianhua Mao, MD

  Children's Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Mao, MD

CONTACT

86057186670015; maojh88@zju.edu.cn

Chunyue Feng

CONTACT

springmoonfeng@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 9, 2023
• Study Start: November 28, 2023
• Primary Completion (Estimated): October 24, 2026
• Study Completion (Estimated): October 24, 2027
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)