Condition
Lupus Nephritis
Lupus nephritis is kidney inflammation caused by lupus, in which the immune system attacks the tiny filters in the kidneys, letting protein leak into the urine. The strongest evidence is for voclosporin, a prescription medicine, and a large placebo-controlled trial found more people reached a complete kidney response when it was added to standard treatment (about 41% versus 23%). No true supplements have gathered enough trial evidence yet, so their role is still unclear.
Sources: PMID 33971155; PMID 30420324
- Supplements studied
- 0
- Medicines and peptides
- 1
- Graded outcomes
- 5
Prescription medicines and peptides studied, for context
| Grade | Outcome | Effect | Size | Studies | People | Studies list |
|---|---|---|---|---|---|---|
| Long-term Efficacy and Safety AURORA 2 extension (n=216): 86.1% completed 3-year study. Treatment well-tolerated with no unexpected safety signals. Sustained efficacy over long-term follow-up. No new safety concerns identified. | Improves (the measure goes up) | Moderate effect | 17 studies | |||
Studies that measured long-term efficacy and safety
| ||||||
| Complete Renal Response AURORA 1 Phase 3 (n=357): Complete renal response at 52 weeks 40.8% voclosporin vs 22.5% placebo (OR 2.7; 95% CI 1.6-4.3; P<0.001). Added to MMF + low-dose steroids. UPCR ≤0.5 mg/mg: 45.3% vs 23.0% (OR 3.1). Clinically and statistically superior. | Improves (the measure goes up) | Large effect | 16 studies | |||
| Response in High Proteinuria Subgroup with UPCR ≥3 g/g (n=148): Complete renal response 34% voclosporin vs 11% control at 12 months (OR 4.43; 95% CI 1.78->9.99; P=0.001). Greater benefit in patients with higher baseline proteinuria. | Improves (the measure goes up) | Large effect | 16 studies | |||
Studies that measured response in high proteinuria | ||||||
| Hypertension Risk SAFETY: New-onset or worsening hypertension common with calcineurin inhibitors. Blood pressure monitoring required. Consider antihypertensive therapy. May require dose adjustment or discontinuation if uncontrolled. | Worsens (the measure goes up) | Moderate effect | 16 studies | |||
| Nephrotoxicity Risk SAFETY: Acute and chronic nephrotoxicity possible. Monitor eGFR regularly. Reduce dose if eGFR decreases. AURA-LV Phase 2: Higher adverse events including deaths in low-dose group (11.2% vs 2.3% high-dose vs 1.1% placebo) - led to dose selection refinement. | Worsens (the measure goes up) | Moderate effect | 16 studies | |||
Key findings
- Long-term Efficacy and SafetyImproves (the measure goes up)
- Complete Renal ResponseImproves (the measure goes up)
- Response in High ProteinuriaImproves (the measure goes up)
Safety notes in the studies
- AURA-LV Phase 2: Higher adverse events including deaths in low-dose group (11.2% vs 2.3% high-dose vs 1.1% placebo) - led to dose selection refinement.
The Lupus Nephritis protocol
2 primary supplements · 2 supporting supplements
- Vitamin D32,000–4,000 IU daily (higher with deficiency)
- Omega-3 Fatty Acids3–4 g EPA/DHA daily
Studies cited
42 studies from PubMed
- Clinical adverse events to voclosporin: a real-world drug safety study based on the FDA Adverse Event Reporting System.
- Recent advances in immunosuppressive therapy for lupus nephritis.
- The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin.
- Effect of Long-Term Voclosporin Treatment on Renal Histology in Patients With Active Lupus Nephritis With Repeat Renal Biopsies.
- Voclosporin Nephrotoxicity: A Myth Debunked?
- Voclosporin Overdose-Induced Peroxisomal Structural Changes and AKI Are Prevented by Renal Indole Detoxifier, INMT.
- Post-marketing safety surveillance of voclosporin: an observational, pharmacovigilance study leveraging faers database study on the safety of voclosporin.
- Phase IV safety evaluation of voclosporin in lupus nephritis patients using the FAERS database for a 42-month period (2021 - 2024).
- Calcineurin Inhibitors: Current Role, Toxicity Management, and Future Frontiers in Immunosuppression.
- Novel therapies in SLE treatment: A literature review.
- Voclosporin: A comprehensive review of its role as a novel calcineurin inhibitor in the management of systemic lupus erythematosus.
- Efficacy and safety of Belimumab, Rituximab and Voclosporin in the treatment of lupus nephritis based on registered clinical trials: A systematic review and network meta-analysis.
- "A Change Is Gonna Come" to Treatment of Lupus Nephritis: A Review.
- Safety and efficacy of long-term voclosporin treatment for lupus nephritis in the phase 3 AURORA 2 clinical trial
- Efficacy of voclosporin in proliferative lupus nephritis with high levels of proteinuria
- Calcineurin inhibitor effects on kidney electrolyte handling and blood pressure: tacrolimus versus voclosporin.
- Efficacy and safety of biologics, multitarget therapy, and standard therapy for lupus nephritis: a systematic review and network meta-analysis.
- The Role of Sodium-Glucose Co-Transporter-2 (SGLT-2) Inhibitors in Treating Lupus Nephritis: A Systematic Review.
- Comparison of a voclosporin-based triple immunosuppressive therapy to high-dose glucocorticoid-based immunosuppressive therapy: a propensity analysis of the AURA-LV and AURORA 1 studies and ALMS.
- Systemic calcineurin inhibitors tacrolimus and voclosporin: A review of off-label dermatologic uses.
- Treatment With Voclosporin and Anifrolumab in a Patient With Lupus Nephritis and Refractory Discoid Lupus Erythematosus: A Case Report and Literature Review.
- Systemic Lupus Erythematosus: A Review.
- Management of systemic lupus erythematosus: a systematic literature review informing the 2023 update of the EULAR recommendations.
- Navigating Lupus Nephritis: A Comprehensive Review of the Current Treatment Trends.
- Update on the efficacy and safety profile of voclosporin: an integrated analysis of clinical trials in lupus nephritis
- Voclosporin and the Antiviral Effect Against SARS-CoV-2 in Immunocompromised Kidney Patients.
- A network meta-analysis of randomized controlled trials comparing the effectiveness and safety of voclosporin or tacrolimus plus mycophenolate mofetil as induction treatment for lupus nephritis.
- Voclosporin: Unique Chemistry, Pharmacology and Toxicity Profile, and Possible Options for Implementation into the Management of Lupus Nephritis.
- Efficacy and safety of immunosuppressive agents for adults with lupus nephritis: a systematic review and network meta-analysis.
- Recent advances in immunotherapies for lupus nephritis.
- The efficacy of immunosuppressive drugs induction therapy for lupus nephritis: a systematic review and network meta-analysis.
- Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial
- Voclosporin (Lupkynis) for lupus nephritis
- Voclosporin: first approval
- Journal Club: Efficacy and Safety of Voclosporin Versus Placebo for Lupus Nephritis (AURORA 1): A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Phase 3 Trial.
- Transplantation and immunosuppression: a review of novel transplant-related immunosuppressant drugs.
- Pharmacokinetic Disposition Difference Between Cyclosporine and Voclosporin Drives Their Distinct Efficacy and Safety Profiles in Clinical Studies.
- Differential Effects of Voclosporin and Tacrolimus on Insulin Secretion From Human Islets.
- A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis
- An evaluation of voclosporin for the treatment of lupus nephritis
- Population PKPD of voclosporin in renal allograft patients.
- Pharmacokinetics of voclosporin in renal impairment and hepatic impairment.