Study on Sibeprenlimab for Patients with IgA Nephropathy

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What is this study about?

This clinical trial is focused on studying a kidney disease called Immunoglobulin A Nephropathy (IgAN). IgAN is a condition where a protein called IgA builds up in the kidneys, causing inflammation and affecting their ability to filter waste from the blood. The trial will evaluate a treatment called Sibeprenlimab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to specific substances in the body. Sibeprenlimab is administered as a solution for injection under the skin, a method known as subcutaneous use. The study will also involve a placebo, which is a substance with no active medication, to compare the effects of Sibeprenlimab.

The purpose of the study is to assess the effectiveness and safety of Sibeprenlimab in treating IgAN. Participants in the trial will receive either Sibeprenlimab or a placebo, in addition to their standard care, for a period of nine months. The trial will monitor changes in the levels of protein in the urine, which is a key indicator of kidney function. The study will also track the overall health and kidney function of participants over a longer period to gather more information about the treatment’s impact.

Throughout the trial, participants will undergo regular check-ups and tests to ensure their safety and to collect data on how well the treatment is working. The trial aims to provide valuable insights into whether Sibeprenlimab can be an effective treatment option for people with IgAN, potentially improving their kidney health and quality of life.

1 joining the trial

Upon joining the trial, participants will be informed about the study’s purpose, which is to evaluate the effectiveness and safety of a medication called sibeprenlimab for treating a kidney condition known as IgA nephropathy.

Participants will be randomly assigned to receive either the medication sibeprenlimab or a placebo, which is a substance with no active medication, to compare the effects.

2 medication administration

The medication sibeprenlimab will be administered as a solution for injection under the skin, known as subcutaneous use.

Participants will receive the medication or placebo regularly over a period of 9 months.

3 monitoring and assessments

Throughout the trial, participants will undergo regular monitoring to assess the medication’s effects. This includes collecting 24-hour urine samples to measure protein levels and conducting blood tests to evaluate kidney function.

Participants will also have their vital signs checked and may undergo physical examinations to ensure their safety during the trial.

4 end of trial evaluation

At the end of the 9-month period, participants will have a final evaluation to determine the change in their condition compared to the beginning of the trial.

The primary focus will be on the change in urine protein levels, while secondary assessments will include kidney function and overall health status.

Who Can Join the Study?

  • Must have a confirmed diagnosis of IgA Nephropathy (a kidney disease) through a kidney biopsy.
  • Must be taking a stable and maximum tolerated dose of authorized medications called ACE inhibitors or angiotensin receptor blockers for at least 3 months before the study starts. These medications help control blood pressure and protect the kidneys.
  • If taking an additional medication called SGLT2 inhibitor for IgA Nephropathy, it must have been started at least 3 months before the study begins.
  • At the start of the study, must have a urine protein-to-creatinine ratio (uPCR) of at least 0.75 g/g or urine protein of at least 1.0 g/day. This is measured from 24-hour urine samples.
  • Must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m². This is a measure of kidney function.
  • If the eGFR is between 30 to 45 mL/min/1.73 m², a kidney biopsy must have been done within 36 months before the study starts.
  • For a specific group in the study, the eGFR must be between 20 to 30 mL/min/1.73 m².
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Patients with any other kidney disease besides IgA Nephropathy cannot participate.
  • Patients who are younger than 18 years old or older than 65 years old are not eligible.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who have participated in another clinical trial within the last 30 days are excluded.
  • Patients with a history of severe allergic reactions to medications are not allowed to join.
  • Patients with uncontrolled high blood pressure are not eligible.
  • Patients with severe liver disease cannot participate.
  • Patients with a history of drug or alcohol abuse in the past year are excluded.
  • Patients with any active infection that requires treatment with antibiotics are not eligible.
  • Patients who have had a major surgery within the last 3 months 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
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital Del Mar Barcelona Spain
Azienda USL Toscana Centro Florence Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hvirpzyseonb Huzunbam Athens Greece
Hrodcmz Taokn Paris France
Umikbsyyxy Gmwtmfd Hmaxctnk Ov Ittwniuu Ioannina Greece
Harpanjq Vbfk dwojnhey Barcelona Spain
Vvhahq dkx Rsztx Uhjbxnefoy Hiwnwolv Sevilla Spain
Aiwqdolsx Uaz Amsterdam The Netherlands
Aidemubfnt Pfonimqm Hmbzxaow Di Mddeshbqn Marseille France
Iskcg Ozdqhjey Pwciimsxjel Sbs Mzxingv Genoa Italy
Hhuqqnll Colpvtt Sbw Csichz Madrid Spain
Voeyktdcl Fyzayknw Ndyfpjpfm V Pmphw Prague Czechia
Aescbep Uuhwq Sibdaejgs Lvysco Do Bsuapqt Bologna Italy
Kdg Slzaj Split Croatia
Cprfpj Hynfrtrlodm Uoybyvmtelbjd De Npqbk Nimes France
Hgluiccm Uqbxwzeniahwl Puvewx Dn Heamog Du Mbtrluzcfdc Majadahonda Spain
Phaqckoiy Htlbjrmg Bordeaux France
Ghtmzi Nkbtvjixcf Tddfhkforrkrt Gzjsii Piktmrnkbyyu Thessaloniki Greece
Cbjh Clmxnk Ckgbxak Aacgfqvfr Bwvym Auonjnjjzt Braga Portugal
Ubozoypiuo Gdaejvr Hmiebezu Oe Hgbjqzrqu Heraklion Greece
Cyflpb Hrgiwffyuzj D Aavenpx Avignon France
Alqqgxq Siympgfxr Ltrkmq Vadpaoi Viterbo Italy
Srrdba Vtzrzrsdp Kcufls Msm Osodbo Krzapa Kaposvar Hungary
Pniukaksbzm Uwncjrfrnzgak Messina Italy
Uulyqofeuttfr Sfthytg Khthhrhbj W Brpxbeakcdx Bialystok Poland
Ixelkals dv Ctoexkjsvctt Hmtemyqncix Ubbaryvxsdxxd dj Suxwk Edtjuak (ejzavuo Saint Priest En Jarez France
Csimyg Hiagqwannfm Eb Uhbxvzbgnmvzz Dp Lvvkiqi Limoges France
Subpvkbnv Rjswjix Uazbayhoox Muphmcz Cretyd Nijmegen The Netherlands
Zgnprjokac Oczl Loxhebw Genk Belgium
Caz Gmjwqgavakqbukng Clermont Ferrand France
Aqmkyzd Uripx Slkiunccw Lwamau Dz Pjeekveb Piacenza Italy
Gcuadg Hfge Zctoqjtocn Gouda The Netherlands
Uxjhkpf Losfr Dy Szoxa Dg Ghiufsnuluji Emlzwm Vila Nova De Gaia Portugal
Amocdnl Uzdcq Ldebto Senpb Slmxucjeo N 8 Bqykyw Vicenza Italy
Pgimjq Pzpqxc Rqrnyudydt Sph jm Cracow Poland
Hujqsfdj Bixcbak Apzkjy Loures Portugal
Hchbnhzn Uttupjhrpixzj Dy Phfzg Asupjgcncv Valencia Spain
Uuwwviajrn Hfdaccrv Memgcp Zagreb Croatia

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
03.09.2022
Croatia Croatia
Not recruiting
03.09.2022
Czechia Czechia
Not recruiting
03.09.2022
France France
Not recruiting
03.09.2022
Germany Germany
Not recruiting
03.09.2022
Greece Greece
Not recruiting
03.09.2022
Hungary Hungary
Not recruiting
03.09.2022
Italy Italy
Not recruiting
03.09.2022
Poland Poland
Not recruiting
03.09.2022
Portugal Portugal
Not recruiting
03.09.2022
Spain Spain
Not recruiting
03.09.2022
The Netherlands The Netherlands
Not recruiting
03.09.2022

Trial locations

Investigated Drugs:

Sibeprenlimab is a medication being tested in this clinical trial. It is given as an injection under the skin. The purpose of this medication is to help people with a kidney condition called Immunoglobulin A Nephropathy. This condition can cause damage to the kidneys over time. The trial is looking to see if Sibeprenlimab can help reduce the amount of protein in the urine, which is a sign of kidney damage. By doing this, the medication aims to protect the kidneys and improve the health of people with this condition.

Investigated Diseases:

IgA Nephropathy – IgA Nephropathy is a kidney disease that occurs when the antibody immunoglobulin A (IgA) builds up in the kidneys. This buildup causes inflammation that can affect the kidneys’ ability to filter waste from the blood. Over time, the inflammation can lead to kidney damage and affect kidney function. The disease often progresses slowly over many years, and symptoms may not be noticeable in the early stages. As the condition advances, it can lead to symptoms such as blood in the urine, swelling in the hands and feet, and high blood pressure. The progression of IgA Nephropathy varies among individuals, with some experiencing a slow decline in kidney function while others may have a more rapid progression.

Trial ID:
2022-500079-30-00
Protocol code:
417-201-00007
NCT ID:
NCT05248646
Trial Phase:
Therapeutic confirmatory (Phase III)

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