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

Description

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

Conditions

C3 Glomerulopathy, Idiopathic Immune-complex-membranoproliferative Glomerulonephritis

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Study Overview

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Study Details

Study overview

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

An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Iptacopan (LNP023) in C3 Glomerulopathy or Idiopathic Immune-complex-membranoproliferative Glomerulonephritis

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

Condition
C3 Glomerulopathy
Intervention / Treatment

-

Contacts and Locations

Lawrenceville

Georgia Nephrology Research Inst, Lawrenceville, Georgia, United States, 30046

Iowa City

University of Iowa Health Care University of Iowa Health Care, Iowa City, Iowa, United States, 52242-1091

New York

Col Uni Med Center New York Presby, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2033-04-20