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ASPAVELI® REDUCED PROTEINURIA BY 68% VS PLACEBO AT 26 WEEKS1,2

VALIANT:2



The largest and broadest Phase 3 study in patients >12 years with native or recurrent C3G or primary IC-MPGN2,8

The trial population was aligned with the known demographics of real-world patients with C3G.2,9

demographics
Valiant Study Design

VALIANT: The largest and broadest Phase 3 study in patients ≥12 years with native or recurrent C3G or primary IC-MPGN1,2,11

STUDY DESIGN2

 

Valiant study design

Primary endpoint2

Aspaveli® reduced proteinuria by 68% vs placebo at 26 weeks*2

Change in proteinuria at Week 26 from baseline††, ‡‡ 2 
Aspaveli efficacy - primary endpoint chart

Relative reduction†† (95% CI), Aspaveli® vs placebo

68.1%

(57.3, 76.2) 

p<0.001¶¶2

 

Maintained a consistent proteinuria reduction over 52 weeks10

change over 52 weeks

Patients were 31x more likely to achieve a >50% reduction with Aspaveli® vs placebo.2,8

Proteinuria reduction

In a post-hoc analysis 51% of Aspaveli®-treated patients achieved <1g/g proteinuria after just 26 weeks.2,9

Proteinuria shift

Proteinuria reduction was consistent across the VALIANT study populations and patient types*2

Adolescent Transplant IS Status

Explore a possible future treatment algorithm for C3G and primary IC-MPGN

Potential treatment algorithm
Proteinuria reduction in pre-specified subgroups
Proteinuria reduction in pre-specified subgroups2
Reduced protenuria forest chart

Intent-to-treat population (all randomised patients). 

Key secondary endpoint

An overall relative eGFR +6.3 mL/min/1,73m2 (95% CI: 0.5-12.1) eGFR relative change from baseline vs. placebo2

Aspaveli stabilised renal function, while eGFR continued to decline with placebo2

Change in eGFR at week 26 from baseline2
Aspaveli - Stabalised renal function chart

Stabilised renal function

across study subgroups2,8,10-14

Adolescent Transplant IS Status

eGFR remained stable over 52 weeks with Aspaveli, while patients switching from placebo showed stabilization after entering the open-label Aspaveli period10

52 weeks

Aspaveli® halted C3 deposition, leading to the reduction of proteinuria and eGFR stabilisation2

Renal biopsy C3G staining, baseline vs week 26§§2
Before Aspaveli treatment
26 weeks after starting Aspaveli

71.4%

(25/35) of Aspaveli®-treated patients achieved 0 intensity staining2

Renal biopsies showed 74% (26/35) of Aspaveli®-treated patients achieved a reduction in staining (≥2 point improvement on the 0–3 scale) by week 26***2,9

Zero intensity staining was also achieved by 100% (4/4)†††12 of transplant patients and 65.4% (17/26) of IS and 88.9% (8/9) of no-IS patients treated with Aspaveli®14

The KHI expert consensus on clinical endpoints in C3G states that efficacy for complement pathway-targeting treatment requires a favourable effect on three endpoints:7

Aspaveli - Efficacy Triad image

 Aspaveli® achieves the TRIAD of efficacy in VALIANT2,7

Downloadable documents

VALIANT Study
PDF 0.7 MB 8 Apr 2026
MOA MOD leaflet - Aspaveli
PDF 1.6 MB 8 Apr 2026
Paediatric Leaflet - Aspaveli
PDF 1.6 MB 8 Apr 2026
Kavanagh 2026
PDF 1.5 MB 22 Apr 2026
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Aspaveli product logo with new endline

EMA indication:

ASPAVELI® is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.1

For the full EMA Aspaveli SmPC, please click here

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via their national pharmacovigilance reporting system. Suspected adverse reactions should also be reported to Sobi via email at [email protected].

Abbreviations

C3, complement 3; C3G, C3 glomerulopathy; CI, confidence interval;  eGFR, estimated glomerular filtration rate; FMU, first-morning spot urine; IC-MPGN, immune complex-mediated membranoproliferative glomerulonephritis; KHI, Kidney Health Initiative; LSM, least squares mean; RAS, renin-angiotensin system; uPCR, urine protein-to-creatinine ratio.

Footnotes

* All adults and adolescents weighing ≥50 kg self-administered 1,080 mg/20 mL. Adolescent patients weighing 30–34 kg received 540 mg/10 mL for the first 2 doses, then 648 mg/12 mL. Adolescent patients weighing 35–49 kg received 648 mg/12 mL for the first dose, then 810 mg/15 mL.8 † Stable, optimised antiproteinuric regimens: ACEis, ARBs, SGLT2is, MMF, and corticosteroids (prednisone <20 mg/dayor equivalent) were permitted in both treatment arms.2 ‡ Adult baseline biopsies are those performed during screening to confirm diagnosis/eligibility, or historical biopsies conducted within 28 weeks of study randomisation. Baseline biopsies will not be required for adolescent patients if an adequate historical biopsy conducted at any time is available to confirm diagnosis.2 ¶ The Week 26 biopsy is only required for adult patients to advance to the OLE period but is not required for adolescent patients who may advance to the OLE period without a biopsy.2,8 § The Week 52 biopsy is optional for all patients.10 ** Participants entering the long-term extension study will not complete the follow-up period.8 ††Using an equal-weighted average from FMU over Weeks 24, 25 and 26.2 ‡‡ Percentages calculated by converting the ratio of geometric means to percentages.2 ¶¶ p<0.001. Intent-to-treat population (all randomised patients).2 §§ Renal biopsies from a Aspaveli-treated C3G native kidney patient.2 *** A reduction in staining was defined as ≥2 point improvement on the 0–3 scale of the C3G histologic index activity score.2,8,9  ††† Evaluable baseline and Week 26 renal biopsies were only available for 4 out of 5 transplanted patients.2

References

  1. Aspaveli EMA Summary of product characteristics. Swedish Orphan Biovitrum AB (publ) January 2026.

  2. Fakhouri F, et al. N Engl J Med 2025;393:2210–20.

  3. Simon-Tillaux N, et al. Presented at American Society of Nephrology Kidney Week 2019, Washington DC, USA; 7–9 November. Poster SA-PO609.

  4. Bomback AS, et al. Kidney Int Rep 2025;10:87–98.

  5. Dixon B, et al. Kidney Int Rep 2023;8:2284–93.

  6. Hoy SM. Drugs 2021;81:1423–30. 

  7. Nester CM, et al. Clin J Am Soc Nephrol 2024;19:1201–8.

  8. Fakhouri F, et al. N Engl J Med 2025;393:2210–20 (Supplementary appendix).

  9. Kavanagh D, et al. Kidney Int Rep. 2026;11(1):17–31.

  10. Fakhouri F, et al. Abstract presented at ERA Congress 2025, Vienna, Austria; June 4–7 2025. Abstract 77. 

  11. Mastrangelo A, et al. Nephrol Dial Transplant. 2025;40(Suppl 3):gfaf116.019. 

  12. Oosterveld M, et al. Nephrol Dial Transplant. 2025;40(Suppl 3):gfaf116.0325.

  13. Kavanagh D, et al. Nephrol Dial Transplant. 2025;40(Suppl 3):gfaf116.020.

  14. Kavanagh D, et al. Presented at ERA Congress 2025, Vienna, Austria; 4–7 June 2025. Abstract 288. 

  15. Wong E, et al. Kidney Int Rep 2023;8(12):2754–64.

  16. Masoud S, et al. Kidney Int 2025;108(3):455–69.

  17. Caravaca-Fontán F, et al. Nephrol Dial Transplant 2022;37:1270–80.

  18. Ghaddar M, et al. Clin J Am Soc Nephrol 2025;20(8):1119–31. 

This website contains information based on the ASPAVELI® Summary of Product Characteristics as approved by European Commission. License conditions vary between countries. Please consult your local Summary of Product Characteristics or Prescribing Information.
 

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