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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04817618
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • C3G

Eligibility Criteria

Sex
ALL
Age
12 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
  • iptacopan — DRUG
    iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

Study Details

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.

Key Dates

Start date
Jul 28, 2021
Status verified
May 2026
Primary completion
Jan 29, 2027
Completion
Jan 29, 2027

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: iptacopan 200mg
    iptacopan 200 mg b.i.d.
  • Placebo Comparator: Placebo to iptacopan 200mg
    Placebo to iptacopan 200mg b.i.d.

Primary Outcome Measure

Adult cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) [ Time Frame: 6 months (double-blind) ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (13)

FacilityCityStateZIPSite coordinators
Childrens Hospital ColoradoAuroraColorado80045
Kati Dugan
[email protected]
+1 720 777 1234
Bradley Dixon (PRINCIPAL_INVESTIGATOR)
Nicklaus Childrens HospitalMiamiFlorida33155
Jorge Haddad
[email protected]
+1 305 661 1515
Ana Paredes (PRINCIPAL_INVESTIGATOR)
Georgia Nephrology Research InstLawrencevilleGeorgia30046-
IN University School of MedIndianapolisIndiana46202-5111-
University of Iowa Health CareIowa CityIowa52242-1091
Nicole Gerot
[email protected]
+1 319 335 7555
Carla Nester (PRINCIPAL_INVESTIGATOR)
University of Iowa Health CareIowa CityIowa52242
Nikki Gerot
+1 (319) 335-0348
Carla Nester (PRINCIPAL_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21287-
Brigham and Womens Hosp Harvard Med SchoolBostonMassachusetts02115-
Hackensack Uni Medical CenterHackensackNew Jersey07601-
Albany Medical CenterAlbanyNew York12208-
Col Uni Med Center New York PresbyNew YorkNew York10032-
Baylor Scott and White ResearchTempleTexas76502-
University of WisconsinMadisonWisconsin53792
Alana Quackenbush
[email protected]
+1 608 265 6020
Sharon Bartosh (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
Childrens Hospital Colorado· Aurora, CONicklaus Childrens Hospital· Miami, FLGeorgia Nephrology Research Inst· Lawrenceville, GAIN University School of Med· Indianapolis, INUniversity of Iowa Health Care· Iowa City, IAJohns Hopkins Hospital· Baltimore, MD

Related Studies