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NCT05588830
The Efficacy and Safety of Telitacicept and Belimumab in Active Lupus Nephritis in the Real World: a Prospective Cohort Study
trial testing Belimumab in Lupus Nephritis in 60 participants. Status unknown.
20 October 2023
Quick facts
| Lead sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 20 October 2022 |
| Primary completion | 20 October 2023 |
| Estimated completion | 20 March 2024 |
Drugs / interventions tested
- Belimumab (BELIMUMAB) — full drug profile →
- Telitacicept — full drug profile →
Conditions studied
- Lupus Nephritis — all drugs for Lupus Nephritis →
- Belimumab — all drugs for Belimumab →
- Telitacicept — all drugs for Telitacicept →
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Who can join
Adults 18 to 65, any sex, with Lupus Nephritis or Belimumab. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05588830
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05588830 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Last refreshed: 20 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05588830.
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