NCT04557462 · Novartis Pharmaceuticals
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
What this study is about
The purpose of this study is to evaluate the long-term safety and how well patients handle the treatment, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials.
View original scientific description
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials.
Interventions
DRUG
LNP023
Capsule 200 mg (b.i.d.) taken orally twice a day
Primary outcome measures
Number and percentage of participants with serious adverse event
Time frame: Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on serious adverse events
Number and percentage of participants with adverse event
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on adverse events
Number and percentage of participants with adverse events of special interest
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment
Summary statistics on adverse events of special interest
Number and percentage of participants with abnormalities in vital signs
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on abnormalities in vital sign parameters
Number and percentage of participants with abnormalities in ECG
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics in abnormalities in ECG parameters
Number and percentage of participants with abnormalities in clinical laboratory evaluations
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on abnormalities in clinical laboratory evaluations
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.
- ≥ 20 ml/min/1.73m2 \*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
- Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.
- Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.
- All participants must be on supportive care regimen of ACEi or ARB\
- as per KDIGO guidelines.
- participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study
Where
- Glendale, Arizona
- San Diego, California
- San Dimas, California
- Aurora, Colorado
- Newark, Delaware
- Chubbuck, Idaho
- Hinsdale, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Rochester, Minnesota
- Kansas City, Missouri
- Las Vegas, Nevada
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
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.
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.
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.
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.
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.
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.
Data: ClinicalTrials.gov · synced Jul 30, 2026 · Source of record for eligibility and locations