RECRUITING

Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.

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Conditions

C3GLNP023iptacopanUPCReGFRproteinuriaQuality of life

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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

The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol. The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

Official Title

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Complement 3 Glomerulopathy.

Quick Facts

Study Start:2021-07-28
Study Completion:2026-07-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04817618

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 to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female participants age ≥ 12 and ≤ 60 years at screening.
  2. * Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.
  3. * Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.
  4. * Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
  5. * UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
  6. * Estimated GFR (using the CKD-EPI formula for ages ≥ 18 years and modified Schwartz formula for ages 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15.
  7. * Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to the start of study treatment.
  8. * If not previously vaccinated or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
  1. * Participants who have received any cell or organ transplantation, including a kidney transplantation.
  2. * Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
  3. * Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%
  4. * Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
  5. * Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration
  6. * The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
  7. * A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae.
  8. * The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.
  9. * The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose \>7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration.
  10. * Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.

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)

Childrens Hospital Colorado
Aurora, Colorado, 80045
United States
Nicklaus Childrens Hospital .
Miami, Florida, 33155
United States
Georgia Nephrology Research Inst
Lawrenceville, Georgia, 30046
United States
University of Iowa Health Care
Iowa City, Iowa, 52242
United States
Novartis Investigative Site
Baltimore, Maryland, 21287
United States
Novartis Investigative Site
Boston, Massachusetts, 02115
United States
Albany Medical Center Department of Medicine
Albany, New York, 12208
United States
Col Uni Med Center New York Presby
New York, New York, 10032
United States
Novartis Investigative Site
Temple, Texas, 76502
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 Date2021-07-28
Study Completion Date2026-07-04

Study Record Updates

Study Start Date2021-07-28
Study Completion Date2026-07-04

Terms related to this study

Keywords Provided by Researchers

  • LNP023
  • iptacopan
  • C3G
  • UPCR
  • eGFR
  • proteinuria
  • Quality of life

Additional Relevant MeSH Terms

  • C3G