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

(APPEAR-C3G)

Sponsored by Novartis Pharmaceuticals

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Mar 4, 2025

Phase

Clinical Trial

Sponsor

Novartis Pharmaceuticals

Enrollment Target

98

Start Date

Jul 2021

๐Ÿ“Š
1 of 98 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Male and female participants age โ‰ฅ 12 and โ‰ค 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 โ‰ฅ 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 โ‰ฅ 18 years and modified Schwartz formula for ages 12 to 17 years) or measured GFR โ‰ฅ 30 ml/min/1.73m2 at screeni

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

98 participants

๐ŸŽ‚

Age Range

12 Years - 60 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Novartis Pharmaceuticals

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Lawrenceville

Georgia

Location available
View Lawrenceville location page
RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page
WITHDRAWN

Baltimore

Maryland

Location available
View Baltimore location page
WITHDRAWN

Boston

Massachusetts

Location available
View Boston location page
WITHDRAWN

Albany

New York

Location available
View Albany location page
RECRUITING

New York

New York

Location available
View New York location page
WITHDRAWN

Temple

Texas

Location available
View Temple location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

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Looking for C3 Glomerulopathy Treatment in Aurora?

Join others in Colorado exploring innovative treatment options through clinical research

C3 Glomerulopathy Treatment Options in Aurora, Colorado

If you're searching for C3 Glomerulopathy treatment in Aurora, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Aurora, Miami, Lawrenceville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with C3 Glomerulopathy. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Colorado
Now Enrolling
Up to 98 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for C3 Glomerulopathy?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for C3 Glomerulopathy

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This C3 Glomerulopathy Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04817618. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.