Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy. (APPEAR-C3G)

May 28, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to placebo and standard of care in patients with native C3G. CLNP023B12301 is a Phase 3 pivotal trial for registration of iptacopan in C3G. The study aims to determine the reduction in UPCR and improvement in eGFR in participants treated with iptacopan compared to placebo, as well as the proportion of participants who achieve a composite renal endpoint consisting of eGFR and UPCR elements. These effects of iptacopan in conjunction with increases in serum C3 levels will provide support for an iptacopan profile that includes stabilization of eGFR, clinically meaningful reductions in proteinuria and inhibition of the complement AP. Kidney biopsies will be performed in adult participants to evaluate histopathological improvements in immunofluorescence and light microscopy that support these functional benefits of iptacopan.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Buenos Aires, Argentina, W3400ABH
        • Completed
        • Novartis Investigative Site
      • CABA, Argentina, C1181ACH
        • Withdrawn
        • Novartis Investigative Site
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5000
        • Withdrawn
        • Novartis Investigative Site
  • Belgium
      • Edegem, Belgium, 2650
        • Withdrawn
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Withdrawn
        • Novartis Investigative Site
  • Brazil
      • Salvador, Brazil, 40323-010
        • Recruiting
        • Novartis Investigative Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Recruiting
        • Novartis Investigative Site
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50740-900
        • Recruiting
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
        • Recruiting
        • Novartis Investigative Site
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 893227-680
        • Withdrawn
        • Novartis Investigative Site
    • São Paulo
      • Santo André, São Paulo, Brazil, 09090-790
        • Withdrawn
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 04038-002
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 05403 000
        • Withdrawn
        • Novartis Investigative Site
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Completed
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Completed
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Withdrawn
        • Novartis Investigative Site
  • China
      • Beijing, China, 100730
        • Recruiting
        • Novartis Investigative Site
      • Beijing, China, 100034
        • Active, not recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Active, not recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510030
        • Active, not recruiting
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Withdrawn
        • Novartis Investigative Site
  • Czechia
      • Prague, Czechia, 128 08
        • Completed
        • Novartis Investigative Site
  • France
      • Lille, France, 59037
        • Completed
        • Novartis Investigative Site
      • Marseille, France, 13005
        • Withdrawn
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Withdrawn
        • Novartis Investigative Site
      • Paris, France, 75015
        • Completed
        • Novartis Investigative Site
      • Paris, France, 75019
        • Withdrawn
        • Novartis Investigative Site
  • Germany
      • Aachen, Germany, 52074
        • Withdrawn
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Completed
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Completed
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Completed
        • Novartis Investigative Site
      • Hanover, Germany, 30625
        • Withdrawn
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Active, not recruiting
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Completed
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Active, not recruiting
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 115 27
        • Withdrawn
        • Novartis Investigative Site
      • Heraklion Crete., Greece, 715 00
        • Completed
        • Novartis Investigative Site
      • Thessaloniki, Greece, 546 42
        • Withdrawn
        • Novartis Investigative Site
      • Thessaloniki, Greece, 546 42
        • Completed
        • Novartis Investigative Site
  • India
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Active, not recruiting
        • Novartis Investigative Site
      • New Delhi, National Capital Territory of Delhi, India, 110017
        • Active, not recruiting
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500058
        • Withdrawn
        • Novartis Investigative Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Active, not recruiting
        • Novartis Investigative Site
    • Uttarakhand
      • Dehradun, Uttarakhand, India, 248001
        • Withdrawn
        • Novartis Investigative Site
  • Israel
      • Petah Tikva, Israel, 4920235
        • Completed
        • Novartis Investigative Site
      • Petah Tikva, Israel, 4941492
        • Completed
        • Novartis Investigative Site
  • Italy
    • BG
      • Ranica, BG, Italy, 24020
        • Active, not recruiting
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20122
        • Withdrawn
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00165
        • Active, not recruiting
        • Novartis Investigative Site
  • Japan
      • Niigata, Japan, 9518520
        • Completed
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4668560
        • Completed
        • Novartis Investigative Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 0788510
        • Completed
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 0608543
        • Completed
        • Novartis Investigative Site
    • Osaka
      • Takatsuki, Osaka, Japan, 5691192
        • Completed
        • Novartis Investigative Site
    • Shiga
      • Ohtsu, Shiga, Japan, 5202192
        • Completed
        • Novartis Investigative Site
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500HB
        • Withdrawn
        • Novartis Investigative Site
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Completed
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Withdrawn
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Completed
        • Novartis Investigative Site
      • Málaga, Spain, 29010
        • Withdrawn
        • Novartis Investigative Site
      • Seville, Spain, 41009
        • Completed
        • Novartis Investigative Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08025
        • Withdrawn
        • Novartis Investigative Site
    • Valencia
      • Port de Sagunt, Valencia, Spain, 46520
        • Withdrawn
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Active, not recruiting
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Withdrawn
        • Novartis Investigative Site
  • Turkey (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Withdrawn
        • Novartis Investigative Site
      • Istanbul, Fatih, Turkey (Türkiye), 34098
        • Withdrawn
        • Novartis Investigative Site
    • Melikgazi
      • Kayseri, Melikgazi, Turkey (Türkiye), 38039
        • Completed
        • Novartis Investigative Site
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06500
        • Completed
        • Novartis Investigative Site
      • Ankara, Yenimahalle, Turkey (Türkiye), 06500
        • Withdrawn
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Active, not recruiting
        • Novartis Investigative Site
      • London, United Kingdom, W12 0HS
        • Completed
        • Novartis Investigative Site
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Withdrawn
        • Novartis Investigative Site
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
        • Active, not recruiting
        • Novartis Investigative Site
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Childrens Hospital Colorado
        • Principal Investigator:
          • Bradley Dixon
        • Contact:
    • Florida
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Childrens Hospital
        • Principal Investigator:
          • Ana Paredes
        • Contact:
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Completed
        • Georgia Nephrology Research Inst
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5111
        • Withdrawn
        • IN University School of Med
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Health Care
        • Principal Investigator:
          • Carla Nester
        • Contact:
          • Nikki Gerot
          • Phone Number: +1 (319) 335-0348
      • Iowa City, Iowa, United States, 52242-1091
        • Recruiting
        • University of Iowa Health Care
        • Principal Investigator:
          • Carla Nester
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Withdrawn
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Withdrawn
        • Brigham and Womens Hosp Harvard Med School
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Withdrawn
        • Hackensack Uni Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Withdrawn
        • Albany Medical Center
      • New York, New York, United States, 10032
        • Completed
        • Col Uni Med Center New York Presby
    • Texas
      • Temple, Texas, United States, 76502
        • Withdrawn
        • Baylor Scott and White Research
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin
        • Principal Investigator:
          • Sharon Bartosh
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female participants age ≥ 12 and ≤ 60 years at screening.
  • Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.
  • 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.
  • Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
  • UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
  • 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.
  • Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to the start of study treatment.
  • 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.

Exclusion Criteria:

  • Participants who have received any cell or organ transplantation, including a kidney transplantation.
  • 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.
  • Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%
  • Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
  • Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration
  • The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
  • A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae.
  • 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.
  • 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.
  • Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: iptacopan 200mg
iptacopan 200 mg b.i.d.
Drug: iptacopan
iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
Other Names:
  • LNP023
Placebo Comparator: Placebo to iptacopan 200mg
Placebo to iptacopan 200mg b.i.d.
Drug: Placebo
Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adult cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection)
Time Frame: 6 months (double-blind)
To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months of treatment.
6 months (double-blind)
Adolescent cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection)
Time Frame: 6 months (double-blind)
To evaluate the effect of iptacopan on proteinuria at 6 months.
6 months (double-blind)
Change from baseline in log-transformed UPCR at the 12-month visit (both study treatment arms).
Time Frame: 12 months (double-blind and open-label)
To evaluate the effect of iptacopan on proteinuria at 12 months.
12 months (double-blind and open-label)
Change in log-transformed UPCR from the 6-month visit to the 12-month visit in the placebo arm
Time Frame: From month 6 to month 12 (open-label)
To evaluate the effect of iptacopan on proteinuria at 12 months.
From month 6 to month 12 (open-label)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in eGFR.
Time Frame: 6 months (double-blind)
To demonstrate the superiority of iptacopan vs. placebo in improving eGFR.
6 months (double-blind)
Proportion of participants who meet the criteria for achieving a composite renal endpoint
Time Frame: 6 months (double-blind)

To demonstrate the superiority of iptacopan vs. placebo in the proportion of participants who meet the criteria for achieving a composite renal endpoint.

A participant meets the requirements of the composite renal endpoint if he/she satisfies: (1) a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and (2) a ≥50% reduction in UPCR compared to the baseline visit.
6 months (double-blind)
Adult cohort: Change from baseline in disease total activity score in a renal biopsy.
Time Frame: 6 months (double-blind)
To demonstrate the effect of iptacopan vs placebo in reducing glomerular inflammation in the kidney.
6 months (double-blind)
Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score.
Time Frame: 6 months (double-blind)
To assess the effect of iptacopan compared to placebo in improvement of patient reported fatigue.
6 months (double-blind)
Number of participants with abnormal clinically significant vital signs, ECGs and safety laboratory measurements
Time Frame: 6 months (double-blind)
To evaluate the safety and tolerability of iptacopan compared to placebo.
6 months (double-blind)
Number of participants with study drug discontinuation due to an AE
Time Frame: 6 months (double-blind)
To evaluate the safety and tolerability of iptacopan compared to placebo
6 months (double-blind)
Proportion of participants who meet the criteria for achieving a composite renal endpoint
Time Frame: 12 months (double-blind and open-label)
To evaluate the effect at 12 months of iptacopan on a composite renal endpoint. A participant meets the requirements of the composite renal endpoint if he/she satisfies: (1) a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and (2) a ≥50% reduction in UPCR compared to the baseline visit.
12 months (double-blind and open-label)
Proportion of patients achieving a composite renal endpoint from the 6-month visit to the 12-month visit of the placebo arm
Time Frame: month 6, month 12 (open-label)
To evaluate the effect at 12 months of iptacopan on a composite renal endpoint. A participant meets the requirements of the composite renal endpoint if he/she satisfies: (1) a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and (2) a ≥50% reduction in UPCR compared to the 6 months visit.
month 6, month 12 (open-label)
Change from baseline in the total activity score in a renal biopsy at 12 months
Time Frame: Baseline, month 12 (double-blind and open-label)
To evaluate the effect at 12 months of iptacopan in reducing glomerular inflammation in the kidney.
Baseline, month 12 (double-blind and open-label)
Change in the total activity score in a renal biopsy from the 6-month visit to the 12-month visit of the placebo arm.
Time Frame: month 6, month 12 (open-label)
To evaluate the effect at 12 months of iptacopan in reducing glomerular inflammation in the kidney.
month 6, month 12 (open-label)
Change from baseline in the FACIT-Fatigue score at 12 months
Time Frame: Baseline, month 12 (double-blind and open-label)
To evaluate the effect at 12 months of iptacopan in improvement of patient reported fatigue
Baseline, month 12 (double-blind and open-label)
Change in the FACIT-Fatigue score from the 6-month visit to the 12-month visit of the placebo arm
Time Frame: month 6, month 12 (open-label)
To evaluate the effect at 12 months of iptacopan in improvement of patient reported fatigue
month 6, month 12 (open-label)
Number of participants with abnormal clinically significant vital signs, ECGs and safety laboratory measurements
Time Frame: 12 months (double-blind and open-label)
To evaluate the safety and tolerability of iptacopan during the 6-month open-label treatment period as well as the entire 12- month treatment period
12 months (double-blind and open-label)
Number of participants with study drug discontinuation due to an AE
Time Frame: 12 months (double-blind and open-label)
To evaluate the safety and tolerability of iptacopan during the 6-month open-label treatment period as well as the entire 12- month treatment period.
12 months (double-blind and open-label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLNP023B12301
  • 2020-004589-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on C3G

Clinical Trials on iptacopan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings