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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 (IC-MPGN)
EU CTIS ID: 2022-502160-20-00
What this study is testing
To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months of treatment
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female adult (aged at least 18 years to ≤ 60 years) and adolescent (12-17 years in non-EU countries and 16-17 years in EU countries, at screening) patients
- 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 during screening/run-in period (performed and assessed locally for adults only).
- Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of 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 moving 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 participants 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, prophylaxis antibiotic treatment should be initiated in accordance with local standard of care.
You likely can't join if
- Participants who have undergone cell or solid organ transplantation, including kidney transplantation.
- Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.
- 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, include o Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV); o Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections o Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histoplasmosis • Renal deposition of immune complexes as a result of a systemic autoimmune disease: o Systemic lupus erythematosus (SLE) o Sjogren syndrome o Rheumatoid arthritis o Mixed connective tissue disease, etc. • 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 biospy
- Kidney biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) or 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 > 380C (100.40F) within 7 days prior to study treatment administration.
See the full eligibility criteria
Who can join
- Male and female adult (aged at least 18 years to ≤ 60 years) and adolescent (12-17 years in non-EU countries and 16-17 years in EU countries, at screening) patients
- 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 during screening/run-in period (performed and assessed locally for adults only).
- Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of 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 moving 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 participants 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, prophylaxis 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 2weeks prior to the first study treatment administration.
What rules you out
- Participants who have undergone cell or solid organ transplantation, including kidney transplantation.
- Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.
- 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, include o Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV); o Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections o Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histoplasmosis • Renal deposition of immune complexes as a result of a systemic autoimmune disease: o Systemic lupus erythematosus (SLE) o Sjogren syndrome o Rheumatoid arthritis o Mixed connective tissue disease, etc. • 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 biospy
- Kidney biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) or 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 > 380C (100.40F) within 7 days prior to study treatment administration.
- A history of recurrent invasive infections caused by encapsulated organisms, e.g., Neisseria meningitis 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 after stopping this medication, whichever is longer, prior to the Screening visit.
- The use of immunosuppressants (except MPAs), cyclophosphamide or systemic prednisone 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vietnam
- Israel
- United Kingdom
- Turkey
- Japan
- Taiwan
- Argentina
- Switzerland
- United States
- India
- Canada
- Korea, Republic of
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vietnam; Israel; United Kingdom; Turkey; Japan; Taiwan and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.