At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Placebo (drug), iptacopan (drug)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- Placebo — drug: Placebo to iptacopan 200mg b.i.d. · iptacopan — drug: iptacopan 200 mg b.i.d.
- Patient visit burden
- Not specified by the sponsor
In plain English
This Novartis study is testing a medicine called iptacopan in people with a rare kidney condition called IC-MPGN, which affects the tiny filters in the kidneys. The researchers want to find out how well the medicine works and how safe it is. Not stated — ask the trial team for details on how the medicine is given.
Who can take part
- Adults aged 18 to 60, and adolescents aged 12 to 17 (16 to 17 in EU countries).
- A diagnosis of IC-MPGN confirmed by a kidney biopsy — within the last 12 months for adults, or within the last 3 years for adolescents. Adults without a recent biopsy result may need one during screening.
- Already taking a maximum recommended or tolerated dose of kidney-protecting blood pressure medicines (called renin angiotensin system inhibitors, such as ACE inhibitors or ARBs) for at least 90 days.
- Stable doses of certain other medicines for protein in the urine or to control the disease for at least 90 days before joining.
- A certain level of protein in the urine (measured from a first morning sample) — the trial team can check this.
- A certain level of kidney function (a filtering rate of at least 30 ml/min/1.73m²) at screening.
- Vaccinations against certain infections (including meningococcal and pneumococcal disease, and Haemophilus influenzae if needed) before starting treatment. If treatment must start sooner, antibiotics may be given.
Who may not be able to
- People who have had an organ or cell transplant, including a kidney transplant.
- People whose IC-MPGN is caused by another condition, such as long-term infections (for example hepatitis B or C, malaria or other infections) or autoimmune diseases (for example lupus, Sjögren's syndrome or rheumatoid arthritis), or by an abnormal protein made by blood cells.
- People with a type of kidney disease called fibrillary glomerulonephritis.
- People with a rapidly worsening form of kidney disease (a big drop in kidney function over 3 months with certain biopsy findings).
- A biopsy showing more than 50% scarring of the kidney filters.
- An active infection or fever (38°C or higher) shortly before starting treatment.
- A history of repeated serious infections caused by certain bacteria.
- Recent use of medicines that block part of the immune system called complement, or certain immunosuppressant medicines.
- Body mass index (BMI) over 38, or body weight under 35 kg.
What taking part involves
- • Taking the study medicine iptacopan (how it is taken and how often is not stated — ask the trial team).
- • Attending study visits for checks, including urine and blood tests to measure protein levels and kidney function.
Time commitment: Not stated — ask the trial team about how long the trial lasts, how many visits are needed, and what taking part involves day to day.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 12 Years to 60 Years
- Who
- All
- Number of participants
- 106
- Started
- 2023-10-02
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for ic-mpgn
- • Phase3 - 106 participants
- • This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis
Who can take part?
- • Ages 12 Years to 60 Years
- • Diagnosed with ic-mpgn
Where?
- • Belfast - Novartis Investigative Site
- • Cardiff - Novartis Investigative Site
- • London - Novartis Investigative Site
- • London - Novartis Investigative Site
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.
More detail
The purpose of this Phase III study is to evaluate the efficacy and safety of iptacopan compared to placebo (both administered in combination with standard of care) in participants (adults and adolescents aged 12-17 years) with idiopathic IC-MPGN. The study aims to demonstrate a reduction in proteinuria and improvement in estimated glomerular filtration rate (eGFR) in participants treated with iptacopan compared to placebo. Change in patient-reported fatigue will also be evaluated. Alternative complement pathway (AP) dysregulation is believed to underlie the clinical manifestations and progression of IC-MPGN. Upon completion of study treatment, participants will have the option to discontinue iptacopan treatment and enter a 30 day safety follow-up or continue iptacopan treatment by transitioning to an open label extension study (CLNP023B12001B; NCT03955445) and continue iptacopan treatment.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years - 60 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e
What the study is looking for
- ✓Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in...
- ✓UPCR ≥ 1.0 g/g (≥ 113 mg/mmol) sampled from the first morning void urine sample at Day -75 and Day -15
Who cannot take part
- ✗Participants who have undergone cell or solid organ transplantation, including kidney transplantation.
- ✗Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:
- ✗Deposition of antigen-antibody immune complexes as a result of any chronic infections, including
- ✗Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);
- ✗Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis;...
See the full criteria
Where Is This Study? (6 UK sites)
Novartis Investigative Site
Belfast BT9 7AB, United Kingdom
Novartis Investigative Site
Cardiff CF14 4XW, United Kingdom
Novartis Investigative Site
London NW3 2QG, United Kingdom
Novartis Investigative Site
London WC1N 3JH, United Kingdom
Novartis Investigative Site
Manchester M13 9WL, United Kingdom
Novartis Investigative Site
Salford M6 8HD, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT
