Randomized, double-blind, placebo-controlled phase 2a study assessing the efficacy and safety of felzartamab for IgA nephropathy.

IGNAZ (NCT05065970) is a randomized, double blind, placebo-controlledPhase 2a study that assessed the efficacy and safety of felzartamab in 54 patients with biopsy-confirmed IgAN despite maximal renin angiotensin system blockade.

IGNAZ (NCT05065970)是一项随机、双盲、安慰剂对照的2a期研究，评估了Felzartamab在54名尽管进行了最大肾素-血管紧张素系统阻断但活检证实为IgAN的患者中的疗效和安全性。

Methods

In part 1, patients were randomized in the 6-month treatment period to receive intravenous placebo (12 patients) or felzartamab in three arms: two doses in 15 days (2-dose, 12 patients), five doses in 2 months (5-dose, 11 patients), or nine doses in five months (9-dose, 13 patients).

在第一部分中，患者在6个月的治疗期间被随机分配接受静脉注射安慰剂（12名患者）或felzartamab的三个剂量方案：15天内给予两次剂量（2-剂量，12名患者），2个月内给予五次剂量（5-剂量，11名患者），或5个月内给予九次剂量（9-剂量，13名患者）。

In part 2, six Japanese patients received the felzartamab 9-dose schedule open-label.

在第二部分中，六名日本患者公开接受felzartamab 9-剂量方案治疗。

Follow-up in parts 1 and 2 was 24 and 12 months, respectively, after the first dose.

第一部分和第二部分的随访时间分别为首次给药后的24个月和12个月。

The primary endpoint was change in proteinuria (urine protein to creatinine ratio [UPCR]) at nine months.

主要终点是九个月时蛋白尿（尿蛋白与肌酐比值[UPCR]）的变化。

Results

Treatment with felzartamab versus placebo led to rapid (within 3-6 months) reduction in least-squares mean UPCR sustained at nine months (placebo, -5.7%; 2-dose, -12.5%; 5-dose, -12.8%; 9-dose, -29.5%; part 2, -44.8%) and at 18 months after ending treatment (24 months), particularly in the 9-dose arm (-44.5%).

与安慰剂相比，felzartamab治疗导致在3-6个月内尿蛋白肌酐比值（UPCR）的最小二乘平均值迅速下降，并在治疗结束后的九个月（-5.7%；2剂，-12.5%；5剂，-12.8%；9剂，-29.5%；第2部分，-44.8%）和18个月（24个月）时持续保持，特别是在9剂组（-44.5%）中。

Mean decreases in estimated glomerular filtration rate were lower with felzartamab than with placebo through 24 months in part 1 and 12 months in part 2.

在第一部分的24个月内和第二部分的12个月内，felzartamab组的估算肾小球滤过率（eGFR）的平均下降幅度低于安慰剂组。

Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2.

Felzartamab的安全性与先前观察一致；不良事件主要为1级或2级。

Conclusions

Treatment with felzartamab results in sustained reduction of proteinuria, suggesting disease improvement.

使用felzartamab治疗可导致蛋白尿持续减少，表明疾病有所改善。

Further evidence is needed to understand the impact of felzartamab on preservation of kidney function in high-risk patients with IgAN.

需要进一步的证据来理解felzartamab对高风险IgAN患者肾功能保护的影响。

trial_registration

Registered at ClinicalTrials.gov with study number NCT05065970.

该研究已在ClinicalTrials.gov注册，注册号为NCT05065970。

Body

IgAN

IgAN