Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT05755386

View on ClinicalTrials.gov ↗

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.

IC-MPGN

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

eGFR

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
Inclusion Criteria: * Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening). * Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only). * Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization * UPCR ≥ 1.0 g/g (≥ 113 mg/mmol) sampled from the first morning void urine sample at Day -75 and Day -15 * Estimated GFR (using the chronic kidney disease \[CKD\]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 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 infection prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local regulations at least 2 weeks prior to the first administration of study treatment. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care. * 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. Exclusion Criteria: * 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; chronic bacterial infections * Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis Renal deposition of immune complexes as a result of a systemic autoimmune disease: * Systemic lupus erythematosus (SLE) * Sjögren syndrome * Rheumatoid arthritis * Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care. Fibrillary glomerulonephritis * Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy. * Kidney biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%. * Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or 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., Neisseria meningitidis and Streptococcus pneumoniae. * The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 3 months or 5 half-lives prior to the Screening visit. * The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose \>7.5 mg/day (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration. * The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement. * Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator. * Body mass index (BMI) \>38 kg/m2 at screening and randomization. Body weight \<35 kg at screening and randomization

Where Is This Study? (6 UK sites)

Novartis Investigative Site

Belfast BT9 7AB, United Kingdom

Recruiting

Novartis Investigative Site

Cardiff CF14 4XW, United Kingdom

Recruiting

Novartis Investigative Site

London NW3 2QG, United Kingdom

Recruiting

Novartis Investigative Site

London WC1N 3JH, United Kingdom

Recruiting

Novartis Investigative Site

Manchester M13 9WL, United Kingdom

Recruiting

Novartis Investigative Site

Salford M6 8HD, United Kingdom

Recruiting

How to Get in Touch

Novartis Pharmaceuticals

Sponsor contact

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

Sponsor contact

CONTACT

+41613241111
Data sourced from ClinicalTrials.gov · Last verified: 2026-07