The Efficacy and Safety of Telitacicept and Belimumab in Active Lupus Nephritis in the Real World: a Prospective Cohort Study

NCT05588830 | Unknown

• 1 other identifier: 2022-353-01
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lupus nephritis is an autoimmune disease. It is an inflammatory kidney damage caused by the deposition of immune complexes in the kidney. It is mainly characterized by the clinical manifestations of albuminuria, hematuria, tubular urine, pyuria, and creatinine elevation. At present, many drugs such as glucocorticoid, immunosuppressant and belimumab are used for clinical treatment, and patients still face difficulties such as complete remission, repeated relapse and so on. This study is a multicenter, prospective, cohort study. In the study, 60 patients with lupus nephritis were enrolled, and they were treated with Telitacicept (n=30) or belimumab (n=30) for 24 weeks on the basis of conventional treatment. To observe the effectiveness and safety of the two treatment schemes for patients. Study drug administration method: Telitacicept was injected subcutaneously, 160mg/time, once a week, for 24 weeks. Belimumab, 10mg/kg, was administered intravenously on the 0, 14 and 28 days, and then once every 28 days until the 24th week During the administration period of this study, the clinician fully evaluated the safety tolerance of patients using this product and decided whether to reduce the dose. The reason for adjusting the treatment plan needs to be recorded. Reference of routine treatment plan: High dose hormone plus cyclophosphamide was used for induction therapy, and then azathioprine or mycophenolate mofetil was used for maintenance therapy; Or high-dose hormone plus mycophenolate mofetil is used for induction therapy, and then mycophenolate mofetil is used for maintenance therapy.

Conditions

Lupus Nephritis; Belimumab; Telitacicept

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving a primary renal efficacy response (PERR)

  The main renal response response (PERR) was defined as: glomerular filtration rate (eGFR) ≥ 60ml/min/1.73m2 or eGFR decreased by no more than 20% from before recurrence; Urine protein: creatinine ratio (uPCR) ≤ 0.7; It is not a treatment failure.

  6 months

Study Arms (2)

Belimumab group

Drug: Belimumab

Telitacicept group

Drug: Telitacicept

Interventions

Belimumab DRUG

Belimumab, 10mg/kg, was administered intravenously on the 0, 14 and 28 days, and then once every 28 days until the 24th week

Belimumab group

Telitacicept DRUG

Telitacicept is injected subcutaneously, 160mg/time, once a week, for a total of 24 weeks

Telitacicept group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lupus nephritis

You may qualify if:

• \. Age 18 to 65 years old, gender is not limited; 2. SLE patients with a clear diagnosis, that is, in line with the SLE classification criteria revised by the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019; 3. Patients with type III and type IV (with or without type V) lupus nephritis or simple type V lupus nephritis confirmed by biopsy within 6 months of the 2003 ISN/RPS criteria; only those with biopsy specimens showing activity were recruited Patients with lesions or active and chronic lesions; 4. ANA titer ≥ 1:80 and/or anti-dsDNA antibody positive; 5. Urine protein-to-creatinine ratio (UPCR) ≥ 1.0 mg/mg (and/or equivalent 24h urine protein level); 6. The urine protein decreased by less than 25% after receiving conventional treatment for at least 3 months before enrollment; 7. Voluntarily participate in this research and sign the informed consent.

You may not qualify if:

• \. eGFR\<30 mL/min/1.73m2; 2. Patients requiring dialysis or kidney transplantation; 3. Patients who have received biological agents in the past; 4. Patients who have received mesenchymal stem cell therapy in the past; 5. Those who are known to be allergic to the study drug; 6. Women who are pregnant or planning to become pregnant in the near future, and women who are breastfeeding; 7. Patients with central nervous system lupus, thrombotic microangiopathy; 8. Patients who are currently suffering from active hepatitis or have a history of severe liver disease or disease; 9. Patients with immunodeficiency, uncontrolled severe infection and active or recurrent peptic ulcer; 10. Subjects who are participating in clinical research of other drugs; In addition to the above, the investigator judges that there are other reasons for not being suitable to participate in this clinical trial.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Lupus Nephritis

Interventions

belimumab; telitacicept

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Sun Lingyun

CONTACT

13705186409; lingyunsun@nju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 20, 2022
• Study Start: October 20, 2022
• Primary Completion: October 20, 2023
• Study Completion: March 20, 2024
• Last Updated: October 20, 2022

Record last verified: 2022-10