RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2019-10-03
Study Completion:2033-04-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03955445

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.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * 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
  2. * 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.
  3. * History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects
  4. * History of HIV or any other immunodeficiency disease

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Georgia Nephrology Research Inst
Lawrenceville, Georgia, 30046
United States
University of Iowa Health Care University of Iowa Health Care
Iowa City, Iowa, 52242-1091
United States
Col Uni Med Center New York Presby
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-03
Study Completion Date2033-04-20

Study Record Updates

Study Start Date2019-10-03
Study Completion Date2033-04-20

Terms related to this study

Keywords Provided by Researchers

  • C3G
  • C3 glomerulopathy
  • C3GN
  • C3 glomerulonephritis
  • DDD
  • dense deposit disease
  • iptacopan
  • LNP023
  • IC-MPGN
  • idiopathic immune-complex- membranoproliferative glomerulonephritis

Additional Relevant MeSH Terms

  • C3 Glomerulopathy
  • Idiopathic Immune-complex-membranoproliferative Glomerulonephritis