Study on the Effects of Iptacopan in Patients with Idiopathic Membranoproliferative Glomerulonephritis (IC-MPGN)

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What is this study about?

This clinical trial is focused on studying a kidney disease called Idiopathic Immune Complex Mediated Membranoproliferative Glomerulonephritis (IC-MPGN). This condition affects the kidneys and can lead to problems with kidney function. The study is testing a treatment called iptacopan, which is taken as a hard gelatin capsule. The purpose of the study is to see if iptacopan can help reduce the amount of protein in the urine, which is a sign of kidney damage, over a period of six months.

Participants in the study will be randomly assigned to receive either iptacopan or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for up to 12 months, with regular check-ups to monitor the participants’ health and the effects of the treatment.

Throughout the study, participants will have their kidney function and overall health closely monitored. This includes measuring the protein levels in their urine and checking their kidney function through blood tests. The study aims to provide valuable information about the safety and effectiveness of iptacopan in treating IC-MPGN, potentially offering a new treatment option for those affected by this kidney disease.

1 randomization

Participants are randomly assigned to receive either iptacopan or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.

2 treatment administration

Participants take the assigned treatment orally in the form of hard gelatin capsules. The specific dosage and frequency are determined by the study protocol and are administered consistently throughout the trial period.

3 treatment duration

The treatment is administered for a period of 6 months. During this time, participants are monitored for changes in their condition and any side effects.

4 primary evaluation

The main goal is to assess the reduction in protein levels in the urine after 6 months of treatment. This is measured by comparing the protein levels at the start of the trial to those at the end.

5 secondary evaluations

Additional assessments include changes in kidney function, measured by estimated glomerular filtration rate (eGFR), and the proportion of participants achieving specific kidney health criteria.

Participants’ fatigue levels are also evaluated using a standardized questionnaire, and any significant changes in vital signs or adverse events are recorded.

6 safety monitoring

Throughout the trial, participants undergo regular monitoring to ensure their safety. This includes checking blood pressure, heart rate, and conducting electrocardiograms (ECGs).

For adolescent participants, additional cardiovascular assessments are performed to evaluate the effects of iptacopan on heart function.

Who Can Join the Study?

  • Participants must be male or female and between 12 and 60 years old at the time of screening.
  • Participants need a confirmed diagnosis of idiopathic IC-MPGN, a specific kidney condition, verified by a kidney biopsy within the last 12 months for adults or within the last 3 years for adolescents. If no biopsy is available for adults, one must be done at screening.
  • Participants must have been taking the highest recommended or tolerated dose of RASi (like ACEI or ARB) for at least 90 days before the study starts. Other medications to reduce protein in urine and control the disease, such as mycophenolic acids, corticosteroids, SGLT2 inhibitors, and mineralocorticoid receptor antagonists, should be stable for at least 90 days before the study starts.
  • Participants must have a UPCR (a measure of protein in urine) greater than 1.0 g/g from urine samples taken on specific days before the study.
  • Participants must have an estimated GFR (a measure of kidney function) greater than 30 ml/min/1.73m² at screening and on a specific day before the study. This is calculated differently for adults and adolescents.
  • Participants must be vaccinated against Neisseria meningitidis and Streptococcus pneumoniae infections before starting the study treatment. If not previously vaccinated or if a booster is needed, the vaccine should be given at least 2 weeks before the study treatment starts. If the study treatment starts earlier, antibiotics should be given as a precaution.
  • If not previously vaccinated or if a booster is needed, participants should be vaccinated against Haemophilus influenzae infections, if available, at least 2 weeks before the study treatment starts. If the study treatment starts earlier, antibiotics should be given as a precaution.

Who Cannot Join the Study?

  • Patients who have a different kidney condition than Idiopathic Immune Complex Mediated Membranoproliferative Glomerulonephritis (IC-MPGN) cannot participate. This is a specific type of kidney disease.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have a history of severe allergic reactions to the study medication or similar medications cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate in this study.
  • Patients who have certain other medical conditions that might interfere with the study cannot participate.
  • Patients who have a history of drug or alcohol abuse that might interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Hospital Consorziale Policlinico Bari Italy
Apejjvv Owfsvfhqifa Ubetxtdmiimjq Finitsny If Dh Nktmog Naples Italy
Ulkebsrgcd Mszhyre Cvpszi Hgllfpxseigdelikr Hamburg Germany
Ujmrmnokpthu Mtqsgim Cneqeal Gcxmvwylq Groningen The Netherlands
Hemkmuaj Ujbxrpgwlbvak 1m De Oxaxerp Madrid Spain
Gqpasj Nwrhypazup Tjigixywesker Gryksl Pkqjyshvjemb Thessaloniki Greece
Urikvgtzdrd Ngssvlpji Mgjksn Martin Slovakia
Utshucsvaw Gdhezza Hofufncv Ox Hefzoxedi Heraklion Greece
Haazgoml Uesmzpcgawkkh Tiyvgxgzvybpg Almeria Spain
Hvcuxkldgyvb Hqnnvjzj Athens Greece
Utvmvpuzrr Gaolpxf Hjefeyru Ob Tsatrytfayqg Atsaq Thessaloniki Greece
Umubhinojc Gwkwpzh Hksuuejv Om Isxpxhfe Ioannina Greece
Uqbirzwtzbf nkajghrgu Lp Pjnvgjaq Kqqusj Kosice Slovakia
Uvlgtnyeczbms Sujivvg Kkfikitte W Bhahgbnsodx Bialystok Poland
Fmedbxzylx Iefrr Cz Gegces Oezxgdiq Mjqbngbx Pkkqwesiabx Milan Italy
Ahqdiseqne Pnckbmfs Hfarqafg Dk Myrrgjpbq Marseille France
Cxycou Hxrbirjokcm Uiwkcegxclxqn Dj Tzxcxnaz Toulouse France
Cpsyai Heedrdvodgk Udgicmqfjebrh Dr Mgixniiuify Montpellier France
Hdxjqvkd Cosilfi Swo Crrfob Madrid Spain
Syravykgdbh Pgcxdicba Zstews Oxbaph Zpyrsxaius Sonddvm Uanmtrduvtwoo W Kbchzgfn Cracow Poland
Ankmnww Onimgmkzrif Usjyaruwluhap Cocaqracvshr Dhddq Svkqlt E Dedhv Sjrixes Dn Tkefvo Turin Italy
Gdrcnhe Uahczplyzc Hlgdlsya Ot Pmjhix Patras Greece
Azrtevrryr Pfkukjob Hutfezyp Dk Prwmc Paris France
Kurfrjii duf Ulepwyqfauff Mroniiry Atx Munich Germany
Ubycanmkiozvwohchvkku Wulrgqanv Avz Wuerzburg Germany
Rcnvtw Mhhttjfewvz Aarhus Denmark
Vvcvndmou Fuyztnoh Nsnqfmjmf V Paxvm Prague Czechia
Ccutvn Hxgolcolvzq Uukqeobvzncft Dm Rvxaxf Rennes France
Rviaaawqvadkqn Copenhagen Denmark
Iparytzu Dn Rerhyjhy Fwghbukacwlyjn Mcmvw Ntosa Ranica Italy
Uwqrordvzwvyghunrqkhk Ejzcy Aay Essen Germany
Fqqvzbni Dt Rdnppqk Cmomig Bcdayklasorxrkpcjp Dobvjwsknfjxpeds Brrsoxanqqi Awhhyx Pf I Sbpaiu Barcelona Spain
Iwljrzsf fprd Kinzfjwjl Tuiqsrutomkgrpqipse usn Ifsxiufmsewh Uzv ghsxi Ulm Germany
Cmhywsd Rqvkeekn Oiovdfwjtylz Gbwn Berlin Germany
Ummzokyyjy Dsuyi Spiup Dv Bsazxiz Brescia Italy
Urzaworvgtifmf Cpfqqxl Kgkgebbvg Wyvfnjbqdljkj Ubigxviwszqj Mkcdodthdk Warsaw Poland
Wtnizsxtoz Sgrdwze Sqrxzptjfhiumze W Ouozyafak Olsztyn Poland
Otqmokhn Pxgeroqghq Bmstkrp Gpnudyxhejr Rome Italy
Hazglzdp Vzgi dhepyzxw Barcelona Spain
Ulvbswutrm Grfjbir Hmqhuwsh Aesmril Gyvgthk Hutsucob Oi Wbom Akqtcb H Aijk Vczkkvq Chaidari Greece
Cykymrj Upzmkmumnie Di Nnhvrlg Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
01.08.2023
Denmark Denmark
Recruiting
01.08.2023
France France
Recruiting
01.08.2023
Germany Germany
Recruiting
01.08.2023
Greece Greece
Recruiting
01.08.2023
Italy Italy
Recruiting
01.08.2023
Poland Poland
Recruiting
01.08.2023
Slovakia Slovakia
Not yet recruiting
01.08.2023
Spain Spain
Recruiting
01.08.2023
The Netherlands The Netherlands
Recruiting
01.08.2023

Trial locations

Iptacopan (LNP023) is a medication being studied for its potential to treat idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). This condition affects the kidneys, leading to inflammation and damage. The trial aims to determine if iptacopan can effectively reduce proteinuria, which is the presence of excess protein in the urine, after six months of treatment.

Idiopathic Immune Complex Mediated Membranoproliferative Glomerulonephritis (IC-MPGN) – This is a rare kidney disorder characterized by inflammation and changes in the kidney’s filtering units, known as glomeruli. The disease is marked by the buildup of immune complexes, which are clusters of antibodies and antigens, leading to damage and scarring of the glomeruli. Over time, this can result in the kidneys’ reduced ability to filter waste and excess fluids from the blood. Patients may experience symptoms such as blood in the urine, swelling in various parts of the body, and high blood pressure. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function, while others may have a more rapid progression.

Trial ID:
2022-502160-20-00
Protocol code:
CLNP023B12302
Trial Phase:
Therapeutic confirmatory (Phase III)

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