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Telitacicept reduces proteinuria in adults with IgA nephropathy in Phase 3 trialNew Drug Slashes Kidney Damage Risk in IgA Nephropathy Patients

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Key Takeaway
Consider interim evidence that telitacicept reduces proteinuria in IgA nephropathy, but await full trial results.

This interim analysis reports results from a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial. The population included 318 adults with biopsy-proven IgA nephropathy and persistent proteinuria (protein level, ≥1.0 g per day) despite supportive care. Participants received subcutaneous once-weekly telitacicept (240 mg) or matching placebo for 39 weeks.

The primary outcome was the geometric mean ratio of the 24-hour urinary protein-to-creatinine ratio at 39 weeks relative to baseline. The percentage change was -58.9% with telitacicept and -8.8% with placebo, a relative difference of -55.0% (95% CI, -61.3 to -47.6; P<0.001). For the secondary outcome, the percentage change in estimated glomerular filtration rate relative to baseline was -1.0% with telitacicept and -7.7% with placebo.

Safety findings included adverse events in 89.3% with telitacicept vs. 78.6% with placebo and serious adverse events in 2.5% vs. 8.2%, respectively. No unexpected safety findings were reported with telitacicept. Discontinuations were not reported.

Key limitations include the interim analysis nature of the data. The study was funded by RemeGen. In patients with IgA nephropathy at high risk for progression, 39 weeks of treatment with telitacicept led to a greater reduction in the 24-hour urinary protein-to-creatinine ratio than placebo, but full results are needed.

This doesn't mean the drug is ready for your pharmacy yet.

Why This Disease Is So Hard to Treat

IgA nephropathy happens when a protein called IgA builds up in the kidneys. Think of your kidneys as a high-end coffee filter. They let waste pass through while keeping important stuff like blood cells inside. In IgA nephropathy, that filter gets clogged with sticky protein deposits.

Over time, the filter becomes damaged. Protein starts leaking into urine. That's a bad sign. It means the kidneys are struggling. About 20 to 40 percent of people with this disease will develop kidney failure within 20 years.

Current treatments include blood pressure medications and steroids. These help, but they don't stop the disease for everyone. Many patients still see their kidney function decline.

The Old Way vs. What Changed

Doctors used to think IgA nephropathy was mostly about inflammation in the kidney tissue itself. Treatments focused on calming that inflammation with steroids or other immune-suppressing drugs.

But here's the twist. Newer research shows the real problem starts earlier. It begins with overactive immune cells that produce too much of two proteins: BAFF and APRIL. These proteins act like fuel for the immune system. When there's too much fuel, the immune system goes into overdrive and starts attacking the kidneys.

Telitacicept works differently. It doesn't just calm inflammation after the damage starts. It targets BAFF and APRIL directly, cutting off the fuel supply before the immune system can cause trouble.

Think of BAFF and APRIL as two keys that unlock a door. That door tells immune cells to multiply and attack. Telitacicept acts like a wad of gum stuffed into the keyhole. The keys can't fit anymore. The door stays locked.

The drug is a fusion protein. That's a lab-made molecule designed to grab onto BAFF and APRIL and neutralize them. Once these proteins are neutralized, the immune system calms down. The kidney filters stop getting clogged with damaging immune complexes.

The trial enrolled 318 adults with biopsy-proven IgA nephropathy. All had persistent protein in their urine despite standard care. Half received weekly injections of telitacicept. The other half got placebo injections.

After 39 weeks, the results were clear. The drug group saw a 58.9 percent reduction in urine protein. The placebo group saw only an 8.8 percent reduction. That's a massive difference.

Kidney function also held up better in the drug group. Estimated filtration rate dropped only 1 percent in the telitacicept group. In the placebo group, it dropped 7.7 percent. That suggests the drug may be protecting kidney function, not just reducing protein leakage.

But There's a Catch

Side effects were more common with telitacicept. About 89 percent of patients on the drug reported some side effect, compared to 79 percent on placebo. Most were mild to moderate.

However, serious side effects were actually less common in the drug group. Only 2.5 percent of telitacicept patients had serious adverse events, compared to 8.2 percent in the placebo group. That's a surprising and encouraging finding.

What This Means for Patients

If you have IgA nephropathy, this news is promising. But it's not time to ask your doctor for this drug yet. Telitacicept is still in clinical trials. It has not been approved by the FDA or other regulatory agencies.

The drug is given as a weekly injection under the skin. That's similar to how some diabetes medications are taken. It's not a pill you can swallow.

For now, the best approach is to keep working with your nephrologist (kidney doctor). Continue your current treatments. Manage your blood pressure. Watch your protein intake. These steps still matter.

The Limits of This Study

This was an interim analysis. That means the researchers looked at the data before the full study was complete. The final results could look different.

The study also only lasted 39 weeks. Kidney disease progresses over years. We don't yet know if the benefits last long-term or if the drug prevents kidney failure down the road.

And while the drug reduced protein in urine, that's a surrogate marker. It's a strong predictor of kidney health, but it's not the same as proving the drug prevents dialysis or transplant.

What Happens Next

The full trial is still ongoing. Researchers will follow these patients longer to see if the benefits hold up. They'll also watch for any late-emerging side effects.

If the final results match this interim analysis, telitacicept could become a new treatment option for IgA nephropathy. That would be a big deal. It would be one of the first drugs designed specifically to target the root cause of this disease, not just its symptoms.

But drug development takes time. Regulatory review, manufacturing, and distribution all add years. For now, this is a hopeful step forward, not a finished journey.

Study Details

Study typeRct
Sample sizen = 318
EvidenceLevel 2
Follow-up9.0 mo
PublishedMay 2026
View Original Abstract ↓
BACKGROUND: The pathogenesis of IgA nephropathy is mediated by B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). Telitacicept is a fusion protein that targets and neutralizes both BAFF and APRIL and, as such, might be effective in IgA nephropathy. METHODS: We now report a prespecified interim analysis of a phase 3, multicenter, double-blind, randomized, placebo-controlled trial, which enrolled adults with biopsy-proven IgA nephropathy and persistent proteinuria (protein level, ≥1.0 g per day), despite appropriate supportive care. Patients were randomly assigned in a 1:1 ratio to receive subcutaneous once-weekly telitacicept (240 mg) or matching placebo. The primary end point was the geometric mean ratio of the 24-hour urinary protein-to-creatinine ratio at 39 weeks relative to baseline. Safety was also evaluated. RESULTS: A total of 318 patients were assigned to receive telitacicept or placebo (159 in each group). At week 39, the percentage change in the 24-hour urinary protein-to-creatinine ratio was -58.9% with telitacicept and -8.8% with placebo, which corresponded to a relative difference (based on the ratio of geometric mean reductions between the two groups) of -55.0% (95% confidence interval [CI], -61.3 to -47.6; P<0.001) in favor of active medication. The percentage change in the estimated glomerular filtration rate relative to baseline was -1.0% (95% CI, -3.2 to 1.2) with telitacicept and -7.7% (95% CI, -9.9 to -5.4) with placebo. Adverse events were more common with telitacicept than with placebo (in 89.3% vs. 78.6% of patients), although serious adverse events were less common (in 2.5% vs. 8.2%). No unexpected safety findings were reported with telitacicept. CONCLUSIONS: In patients with IgA nephropathy at high risk for progression, 39 weeks of treatment with telitacicept led to a greater reduction in the 24-hour urinary protein-to-creatinine ratio than placebo. (Funded by RemeGen; TELIGAN ClinicalTrials.gov number, NCT05799287.).
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