Long-term follow-up of ianalumab with or without stopping treatment for people with lupus nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants who completed the SIRIUS-LN core study are invited into a 2-year open-label extension to monitor long-term outcomes. Those who achieved complete or partial renal response at the end of the core study may stop study treatment and be followed on standard-of-care, while participants who did not respond or who were already on open-label treatment will receive open-label ianalumab 300 mg. Investigators will track sustained remission, renal flares, and safety over two years, with the option to restart open-label ianalumab if a renal flare occurs. The extension uses clinician judgement for continued participation and standard exclusion rules such as pregnancy and prohibited concomitant therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent prior to participation in the extension study.
2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.

Exclusion Criteria:

1. Use of prohibited therapies
2. Pregnant or nursing (lactating) women.

Where it's running

• Circuit Clinical
  Orchard Park, New York, United States Recruiting
• Novartis Investigative Site
  Vitória, Espírito Santo, Brazil Recruiting
• Novartis Investigative Site
  Salvador, Estado de Bahia, Brazil Recruiting
• Novartis Investigative Site
  Belo Horizonte, Minas Gerais, Brazil Recruiting
• Novartis Investigative Site
  Recife, Pernambuco, Brazil Recruiting
• Novartis Investigative Site
  Santo André, São Paulo, Brazil Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.