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Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN

NCT03955445

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: C3 Glomerulopathy, Immune-complex-membranoproliferative Glomerulonephritis

Interventions: LNP023

Countries: United States, Argentina, Brazil, Canada, China, Czechia, France, Germany

This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis

Eligibility overview

Sex: ALL

Age: 12 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

\- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug

Exclusion Criteria:

* Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study
* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening.
* History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects
* History of HIV or any other immunodeficiency disease

Other protocol-defined inclusion/exclusion criteria may apply
Locations (53)
  • Aurora, Colorado, United States
  • Lawrenceville, Georgia, United States
  • Iowa City, Iowa, United States
  • Minneapolis, Minnesota, United States
  • New York, New York, United States
  • CABA, Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Belo Horizonte, Minas Gerais, Brazil
  • Recife, Pernambuco, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Botucatu, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Salvador, Brazil
  • Toronto, Ontario, Canada
  • Beijing, China
  • Shanghai, China
  • Prague, Czechia
  • Montpellier, France
  • Paris, France
  • Paris, France
  • Toulouse, France
  • Erlangen, Germany
  • Essen, Germany
  • Hamburg, Germany
  • Heidelberg, Germany
  • Mainz, Germany
  • Heraklion Crete., Greece
  • Thessaloniki, Greece
  • Petah Tikva, Israel
  • Petah Tikva, Israel
  • + 23 more on CT.gov