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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03955445
Phase
PHASE3
Status
Recruiting
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Conditions

  • C3 Glomerulopathy
  • Immune-complex-membranoproliferative Glomerulonephritis

Eligibility Criteria

Sex
ALL
Age
12 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • LNP023 — DRUG
    LNP023 capsules

Study Details

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

Key Dates

Start date
Oct 3, 2019
Status verified
Apr 2026
Primary completion
May 30, 2036
Completion
May 30, 2036

Study Design

Enrollment
225 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort D: particpants with native C3G randomised to iptacopan in CLNP023B12301
    Native C3G participants (adults and adolescents) from study CLNP023B12301 who were randomized to iptacopan in the core study. Receiving iptacopan capsules 200mg b.i.d
  • Experimental: Cohort E: participants with IC-MPGN randomized to placebo in CLNP023B12302
    IC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d
  • Experimental: Cohort F: participants with IC-MPGN randomized to ipatocan in CLNP023B12302
    IC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to iptacopan in the core study receiving iptacopan capsules 200mg b.i.d
  • Experimental: Cohort A: participants with native kidneys from CLNP023X2202
    C3G participants from study CLNP023X2202 with native kidneys receiving iptacopan capsules 200 mg b.i.d
  • Experimental: Cohort B: participants with transplanted kidneys and recurrent C3G from CLNP023X2202
    C3G participants from study CLNP023X2202 who have undergone kidney transplant and have recurrence of C3G receiving iptacopan capsules 200 mg b.i.d
  • Experimental: Cohort C: Participants with native C3G randomized to placebo in CLNP023B12301
    Native C3G Participants (adults and adolescents) from CLNP023B12301 study who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d

Primary Outcome Measure

CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint [ Time Frame: 9-month visit ]

Central Contacts

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

Locations (5)

FacilityCityStateZIPSite coordinators
Childrens Hospital ColoradoAuroraColorado80045
Kati Dugan
[email protected]
+1 720 777 6895
Bradley Dixon (PRINCIPAL_INVESTIGATOR)
Georgia Nephrology Research InstLawrencevilleGeorgia30046
Lisa Franklin
[email protected]
+1 404 645 7850#3024
James A Tumlin (PRINCIPAL_INVESTIGATOR)
University of Iowa Health CareIowa CityIowa52242-1091
Nicole Gerot
[email protected]
+1 319 335 7555
Carla Nester (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Brady Wallner
[email protected]
Nattawat Klomjit (PRINCIPAL_INVESTIGATOR)
Col Uni Med Center New York PresbyNew YorkNew York10032
Brianna Ortiz
[email protected]
+1 212 304 5684
Andrew S Bomback (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
Childrens Hospital Colorado· Aurora, COGeorgia Nephrology Research Inst· Lawrenceville, GAUniversity of Iowa Health Care· Iowa City, IAUniversity of Minnesota· Minneapolis, MNCol Uni Med Center New York Presby· New York, NY

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