ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on Twitter

Kidney Week

Abstract: INFO34

A Phase 2 Study Evaluating the Efficacy and Safety of Ravulizumab in Patients With IgA Nephropathy (IgAN) or Proliferative Lupus Nephritis (LN)

Session Information

  • Informational Posters
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

  • No subcategory defined

Authors

  • Garlo, Katherine, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
  • Rice, Kara, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
  • Spoerri, Nicole, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
  • Najafian, Nader, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
Description

IgAN and LN are characterized by deposition of immune complexes, leading to activation of complement and inflammation. Despite treatment, many patients with IgAN or LN progress to kidney failure. This global, multicenter, phase 2 study (NCT04564339) will evaluate the efficacy and safety of ravulizumab, a humanized monoclonal antibody that inhibits complement C5, in adults with IgAN or LN and is open for enrollment. Key study design elements and endpoints are shown in the Figure. Key inclusion criteria include biopsy-confirmed IgAN or LN, proteinuria, and specific vaccination requirements. Key exclusion criteria include eGFR <30 mL/min/1.73m2 and prior complement or biologic therapy. The primary endpoint is change in proteinuria assessed by 24-hour urine collection(s) from baseline to Week 26. The study design incorporates 2:1 randomization in favor of the study drug arm, continued administration of standard of care medications in all treatment groups, placebo crossover to treatment for IgAN after Week 26, potential use of rescue therapy in LN, interim pharmacokinetic/pharmacodynamic analysis, and an observational follow-up period allowing data collection after study drug discontinuation.

Figure. Study schematic for the LN and IgAN cohort

Funding

  • Alexion, AstraZeneca Rare Disease
Abstract: INFO34

A Phase 2 Study Evaluating the Efficacy and Safety of Ravulizumab in Patients With IgA Nephropathy (IgAN) or Proliferative Lupus Nephritis (LN)

Session Information

  • Informational Posters
    November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Garlo, Katherine, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
  • Rice, Kara, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
  • Spoerri, Nicole, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
  • Najafian, Nader, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
Description

IgAN and LN are characterized by deposition of immune complexes, leading to activation of complement and inflammation. Despite treatment, many patients with IgAN or LN progress to kidney failure. This global, multicenter, phase 2 study (NCT04564339) will evaluate the efficacy and safety of ravulizumab, a humanized monoclonal antibody that inhibits complement C5, in adults with IgAN or LN and is open for enrollment. Key study design elements and endpoints are shown in the Figure. Key inclusion criteria include biopsy-confirmed IgAN or LN, proteinuria, and specific vaccination requirements. Key exclusion criteria include eGFR <30 mL/min/1.73m2 and prior complement or biologic therapy. The primary endpoint is change in proteinuria assessed by 24-hour urine collection(s) from baseline to Week 26. The study design incorporates 2:1 randomization in favor of the study drug arm, continued administration of standard of care medications in all treatment groups, placebo crossover to treatment for IgAN after Week 26, potential use of rescue therapy in LN, interim pharmacokinetic/pharmacodynamic analysis, and an observational follow-up period allowing data collection after study drug discontinuation.

Figure. Study schematic for the LN and IgAN cohort

Abstract: INFO34

A Phase 2 Study Evaluating the Efficacy and Safety of Ravulizumab in Patients With IgA Nephropathy (IgAN) or Proliferative Lupus Nephritis (LN)

Session Information

  • Informational Posters
    November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Garlo, Katherine, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
  • Rice, Kara, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
  • Spoerri, Nicole, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
  • Najafian, Nader, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
Description

IgAN and LN are characterized by deposition of immune complexes, leading to activation of complement and inflammation. Despite treatment, many patients with IgAN or LN progress to kidney failure. This global, multicenter, phase 2 study (NCT04564339) will evaluate the efficacy and safety of ravulizumab, a humanized monoclonal antibody that inhibits complement C5, in adults with IgAN or LN and is open for enrollment. Key study design elements and endpoints are shown in the Figure. Key inclusion criteria include biopsy-confirmed IgAN or LN, proteinuria, and specific vaccination requirements. Key exclusion criteria include eGFR <30 mL/min/1.73m2 and prior complement or biologic therapy. The primary endpoint is change in proteinuria assessed by 24-hour urine collection(s) from baseline to Week 26. The study design incorporates 2:1 randomization in favor of the study drug arm, continued administration of standard of care medications in all treatment groups, placebo crossover to treatment for IgAN after Week 26, potential use of rescue therapy in LN, interim pharmacokinetic/pharmacodynamic analysis, and an observational follow-up period allowing data collection after study drug discontinuation.

Figure. Study schematic for the LN and IgAN cohort