Study on Vemircopan for Adults with Lupus Nephritis or IgA Nephropathy

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What is this study about?

This clinical trial is focused on studying two kidney-related diseases: Lupus Nephritis and Immunoglobulin A Nephropathy. The treatment being tested is a medication called ALXN 2050, which is taken as a film-coated tablet. The purpose of the study is to evaluate how effective ALXN 2050 is in reducing the amount of protein in the urine, a condition known as proteinuria, which is common in these diseases.

Participants in the study will be randomly assigned to receive either the ALXN 2050 tablets or placebo tablets. 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 unbiased. The study will take place over a period of time, during which participants will be monitored for changes in their condition and any side effects they may experience.

The trial aims to find the most effective dose of ALXN 2050 for treating these kidney diseases. Participants will have regular check-ups to assess their kidney function and overall health. The study will also look at how the medication affects the body and its safety. The ultimate goal is to determine if ALXN 2050 can be a beneficial treatment option for people with Lupus Nephritis or Immunoglobulin A Nephropathy.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the study medication, ALXN2050, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

2 medication administration

The participant will take the assigned medication orally in the form of a film-coated tablet. The specific dosage and frequency will be determined by the study protocol and communicated to the participant by the study team.

3 treatment period

The treatment period will last until Week 50. During this time, the participant will continue taking the medication as instructed and attend regular study visits for monitoring.

4 monitoring and assessments

Throughout the study, the participant will undergo various assessments to monitor health and the effects of the medication. These assessments include measuring protein levels in urine, blood pressure checks, and other laboratory tests.

5 end of treatment

At the end of the treatment period, the participant will stop taking the study medication. Final assessments will be conducted to evaluate the overall effects of the treatment.

6 follow-up

After completing the treatment, the participant may be asked to attend follow-up visits to ensure ongoing health and to gather additional data for the study.

Who Can Join the Study?

For the Lupus Nephritis (LN) Cohort:
- Must have a clinical diagnosis of Systemic Lupus Erythematosus (SLE), which is a condition where the immune system attacks the body’s own tissues, confirmed by specific criteria from 2019.
- Must have a diagnosis of a specific type of kidney inflammation (LN Class III or IV) confirmed by a kidney biopsy done within 6 months before or during the screening period. This biopsy is a procedure where a small piece of kidney tissue is taken to look for disease.
- Must have active kidney inflammation at screening that requires or is receiving treatment to suppress the immune system, as determined by the study doctor.
- Must have a certain level of proteinuria, which means having too much protein in the urine, with a UPCR (urine protein-to-creatinine ratio) of at least 1 gram per gram based on a 24-hour urine collection during the screening period.
For the Immunoglobulin A Nephropathy (IgAN) Cohort:
- Must have a confirmed diagnosis of primary IgAN, a kidney disease caused by deposits of a protein called immunoglobulin A, based on a kidney biopsy done at any time before or during the screening period.
- Must have an average proteinuria of at least 1 gram per day based on two complete and valid 24-hour urine collections during the screening period.
- If the kidney biopsy was done more than a year before screening, there must be evidence of hematuria, which means blood in the urine, shown by a positive urine test or at least 10 red blood cells per high power field under a microscope during the screening period.
- Must be taking a stable and optimal dose of RAS inhibitors, which are medications that help control blood pressure and protect the kidneys, for at least 3 months before screening, with no expected changes in dose during the study period. Participants who cannot tolerate these medications may still be included.
- Must have controlled and stable blood pressure, defined as less than 140/90 millimeters of mercury, for the past 3 months before joining the study.
Participants can be of any gender.
Participants must be within the age range specified by the study.

Who Cannot Join the Study?

Patients with other serious kidney diseases not related to Lupus Nephritis or Immunoglobulin A Nephropathy.
Patients who have had a kidney transplant.
Patients currently receiving treatment that could interfere with the study medication.
Patients with a history of severe allergic reactions to similar medications.
Patients with uncontrolled high blood pressure.
Patients with active infections that require treatment.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients with any other medical condition that the study doctors believe would make participation unsafe.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
San Camillo Forlanini Hospital	Rome	Italy
Fundacio Puigvert	Barcelona	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Ospedale San Giovanni Bosco	Turin	Italy
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Servei De Salut De Les Illes Balears	Palma	Spain
University Hospital Consorziale Policlinico	Bari	Italy
Ujjeoxyxxqtmgeoruxzba Ecbqh Aau	Essen	Germany
Kmeyxjbi Ffwxx gwo	Fulda	Germany
Kivkrsop dcl Ujklmyqkjcdu Mwctfwqh Acg	Munich	Germany
Ayfnnvm Usbwi Slsmintut Ligkpm Db Bifuegp	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	20.09.2022
Italy	Not recruiting	20.09.2022
Spain	Not recruiting	20.09.2022

Trial locations

Investigated drugs:

Vemircopan

ALXN2050 is a medication being studied for its ability to reduce proteinuria, which is the presence of excess proteins in the urine. This condition is often associated with kidney diseases such as Proliferative Lupus Nephritis (LN) and Immunoglobulin A Nephropathy (IgAN). The trial aims to determine how effective and safe ALXN2050 is for adults suffering from these conditions.

Investigated diseases:

Lupus Nephritis – Lupus Nephritis is a kidney disorder that occurs as a complication of systemic lupus erythematosus, an autoimmune disease. It involves inflammation of the kidneys, which can lead to damage over time. The condition is characterized by the presence of protein in the urine, swelling, and high blood pressure. As the disease progresses, it can cause a decline in kidney function. The severity of symptoms can vary, and the disease may have periods of remission and flare-ups.

Immunoglobulin A Nephropathy – Immunoglobulin A Nephropathy, also known as IgA Nephropathy, is a kidney disease caused by deposits of the protein immunoglobulin A in the kidneys. This leads to inflammation that can affect the kidneys’ ability to filter waste from the blood. The disease often progresses slowly over many years, and symptoms may include blood in the urine, proteinuria, and high blood pressure. Some individuals may experience episodes of visible blood in the urine, especially after infections. Over time, IgA Nephropathy can lead to chronic kidney disease. The progression and severity of the disease can vary widely among individuals.

Trial ID:

2023-504825-38-00

Protocol code:

ALXN2050-NEPH-201

NCT ID:

NCT05097989

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Vemircopan for Adults with Lupus Nephritis or IgA Nephropathy

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