Clinical Trials in Turkey / NCT05138133
Active, not recruiting
Phase 3
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
NCT05138133 · tracked via the Priya Life Science Turkey tracker
Condition(s) studied
Lupus Nephritis
Investigational drug(s) / intervention(s)
Anifrolumab →Placebo
Anifrolumab: Anifrolumab intravenous infusion (IV)
Placebo: Placebo intravenous infusion (IV)
Study summary
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
Eligibility
Inclusion Criteria:
1. Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
2. Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
3. Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)
4. eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
5. Fulfills updated 2019 EULAR/ACR SLE classification criteria.
6. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
Exclusion Criteria:
1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
2. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
3. Evidence of hepatitis C or active hepatitis B.
4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
5. Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide \> 2 pulses of high-dose (≥ 0.5 g/m2) or \> 4 doses of low dose (500 mg every 2 weeks) or Average MMF \> 2.5 g/day (or \> 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus \> 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
6. Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
7. Known intolerance to ≤ 1.0 g/day of MMF.
8. Any history of severe COVID-19 infection.
Primary outcome measure(s)
- Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group — Week 52
CRR is defined as: * UPCR ≤ 0.5 mg/mg * eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%
Trial sites (164)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Glendale | Arizona | |
| Research Site | La Palma | California | |
| Research Site | Los Angeles | California | |
| Research Site | Upland | California | |
| Research Site | Plantation | Florida | |
| Research Site | Atlanta | Georgia | |
| Research Site | Louisville | Kentucky | |
| Research Site | Summit | New Jersey | |
| Research Site | Manhasset | New York | |
| Research Site | New York | New York | |
| Research Site | Winston-Salem | North Carolina | |
| Research Site | Middleburg Heights | Ohio | |
| Research Site | Colleyville | Texas | |
| Research Site | Edinburg | Texas | |
| Research Site | El Paso | Texas | |
| Research Site | Houston | Texas | |
| Research Site | CABA | Argentina | |
| Research Site | Ciudad de Buenos Aires | Argentina | |
| Research Site | La Plata | Argentina | |
| Research Site | Rosario | Argentina | |
| Research Site | San Juan | Argentina | |
| Research Site | Brussels | Belgium | |
| Research Site | Leuven | Belgium | |
| Research Site | Liège | Belgium | |
| Research Site | Belo Horizonte | Brazil | |
| Research Site | Campinas | Brazil | |
| Research Site | Cuiabá | Brazil | |
| Research Site | Maringá | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Recife | Brazil | |
| Research Site | Salvador | Brazil | |
| Research Site | São José do Rio Preto | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | Plovdiv | Bulgaria | |
| Research Site | Sofia | Bulgaria | |
| Research Site | Beijing | China | |
| Research Site | Beijing | China | |
| Research Site | Bengbu | China |
+ 124 more sites — see the full list on the official registry below.
On this site
📄 Saphnelo (anifrolumab) drug profile →More AstraZeneca trials in Turkey
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05138133 on ClinicalTrials.gov ↗ ← All trials in Turkey