Study on Anifrolumab for Adults with Active Lupus Nephritis

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What is this study about?

This clinical trial is focused on studying Active Proliferative Lupus Nephritis, a condition where the immune system attacks the kidneys, causing inflammation and damage. The study will evaluate the effectiveness and safety of a treatment called Anifrolumab, which is given as a concentrate for solution for infusion, meaning it is administered directly into the bloodstream through a vein. Participants in the study will receive either Anifrolumab or a placebo, which is a substance with no active medication, to compare the outcomes.

The purpose of the study is to determine how well Anifrolumab works in helping patients achieve a complete renal response, which means improving kidney function and reducing inflammation. The study will involve regular visits to the clinic for infusions and monitoring over a period of time. Participants will be closely observed to ensure their safety and to track any changes in their condition.

Throughout the study, participants will receive standard care for their condition in addition to the study treatment. The goal is to see if adding Anifrolumab to the usual care can provide better outcomes for patients with Active Proliferative Lupus Nephritis. The study will help researchers understand if this treatment can be a beneficial option for managing this challenging condition.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the study medication, anifrolumab, 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 study medication, Saphnelo 300 mg, is administered as a concentrate for solution for infusion. This means it is given through a vein, a method known as intravenous use.

The infusion is scheduled to occur at regular intervals as determined by the study protocol.

3 monitoring and assessments

Throughout the study, participants will undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes measuring the urine protein to creatinine ratio and estimated glomerular filtration rate (eGFR) to evaluate kidney function.

Participants will also be monitored for any side effects or adverse reactions to the medication.

4 primary evaluation

The primary goal is to achieve a complete renal response (CRR) by Week 52. This involves meeting specific criteria related to kidney function, such as maintaining a urine protein to creatinine ratio of 0.5 mg/mg or less and an eGFR of 60 mL/min/1.73 m² or higher.

5 secondary evaluation

Secondary evaluations include sustained reduction in oral corticosteroid (OCS) dosage and time to sustained CRR. The aim is to reduce the OCS dose to 7.5 mg/day or less by Week 24 and maintain this dosage through Week 52.

Other assessments include cumulative urine protein to creatinine ratio and time to renal events, such as end-stage kidney disease or significant changes in kidney function.

6 study duration

The study is expected to continue until March 2028, with regular follow-ups and assessments throughout this period to ensure comprehensive evaluation of the treatment’s efficacy and safety.

Who Can Join the Study?

Must be between 18 and 70 years old at the time of screening.
Must have a negative COVID-19 test result and no known or suspected exposure to COVID-19 within 2 weeks before screening.
Must weigh at least 40 kilograms (about 88 pounds).
Females who are or have been sexually active and have an intact cervix must have a normal cervical cancer screening test result within the last 2 years.
Must use contraception as per local regulations for clinical studies.
Must meet the updated 2019 criteria for SLE (Systemic Lupus Erythematosus).
Must have a positive test result for ANA (Antinuclear Antibody), anti-dsDNA (anti-double-stranded DNA), or anti-Sm (anti-Smith) during screening or historically.
Must have a urine protein to creatinine ratio greater than 1 mg/mg, based on two samples taken during screening.
Must have active proliferative LN (Lupus Nephritis) Class III or IV, with or without Class V, based on a kidney biopsy within 6 months before signing the consent form or during screening. The participant must need high-dose corticosteroids and immunosuppressive therapy.
Must have an eGFR (estimated Glomerular Filtration Rate) of at least 35 mL/min/1.73 m², which is a measure of kidney function.
Must have adequate peripheral venous access, meaning veins that can be used for blood draws or infusions.
Must have a chest X-ray or CT scan showing no active infection, no signs of tuberculosis (TB), no cancer, and no suspicious lung nodules. Any abnormalities should be related to SLE.
Must meet all TB criteria: no signs or symptoms of active TB, no history suggesting active TB, a chest X-ray showing no active or past TB, no recent contact with someone with active TB, or if there was contact, must have been evaluated and treated for latent TB if needed. Must have a TB test with results as per study rules.

Who Cannot Join the Study?

Having any other serious health condition that could interfere with the study.
Being pregnant or breastfeeding.
Having a history of severe allergic reactions to similar medications.
Using certain medications that might affect the study results.
Having a recent history of drug or alcohol abuse.
Having an active infection that requires treatment.
Having received a live vaccine within a certain time before the study.
Having a history of certain types of cancer.
Having a condition that affects the immune system, other than lupus nephritis.
Having participated in another clinical trial recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Medizinische Hochschule Hannover	Hanover	Germany
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie	Rzeszow	Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Diagnostics And Consultation Center Convex Ltd.	Sofia	Bulgaria
Centre hospitalier universitaire de Liege	Liege	Belgium
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Centrum Medyczne Intercor Sp. z o.o.	Bydgoszcz	Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie	Olsztyn	Poland
Azienda Ospedaliera di Padova	Padua	Italy
University Of Debrecen	Debrecen	Hungary
Semmelweis University	Budapest	Hungary
Universita’ Politecnica Delle Marche	Ancona	Italy
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
University Of Pecs	Pecs	Hungary
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
medius KLINIKEN gGmbH	Kirchheim Unter Teck	Germany
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny Im Wiktora Degi Uniwersytetu Medycznego Im Karola Marcinkowskiego W Poznaniu	Poznan	Poland
Cbqkqoanb Uubsogexvjwsvt Sfroxtipd	Woluwe-Saint-Lambert	Belgium
Aniuiie Sbrwllbhl Lvckqd Dr Soghqyl	Salerno	Italy
Ujprfzybkb Hfhovvll Cnujlno	Cologne	Germany
Arhhnumzti Pbumiyml Hmiffekw Dl Mpfduoyaf	Marseille	France
Uzzscxkgelcpgtqpaizmg Dxjsvgcsdwy Asv	Duesseldorf	Germany
Autaznibp Usz	Amsterdam	The Netherlands
Azqpoux Uzifk Sewimself Lxwtcp Dv Bwijmkf	Bologna	Italy
Uzrqomlnam Dqfmz Susca Dj Riqk Li Stlibqcn	Rome	Italy
Hisscvfv Uimqsxspzgefcd Sqcpnmdtff &ikqrqt Hhqgnmp dw Hajmmufzbxb	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	15.02.2022
Bulgaria	Not recruiting	15.02.2022
France	Not recruiting	15.02.2022
Germany	Not recruiting	15.02.2022
Hungary	Not recruiting	15.02.2022
Italy	Not recruiting	15.02.2022
Poland	Not recruiting	15.02.2022
The Netherlands	Not recruiting	15.02.2022

Trial locations

Investigated drugs:

Anifrolumab

Anifrolumab is a medication being studied for its effectiveness in treating adults with active proliferative lupus nephritis, a type of kidney inflammation caused by lupus. The trial aims to see how well anifrolumab works when added to the standard of care treatments for this condition.

Investigated diseases:

Lupus nephritis

Active Proliferative Lupus Nephritis – This is a kidney condition that occurs as a complication of systemic lupus erythematosus, an autoimmune disease. In this condition, the immune system mistakenly attacks the kidneys, leading to inflammation and damage. The term “proliferative” refers to the increase in the number of cells in the kidney’s filtering units, which can impair their function. Over time, this can result in protein leakage into the urine and reduced kidney function. Symptoms may include swelling, high blood pressure, and changes in urine output. The progression of the disease can vary, with periods of flare-ups and remission.

Trial ID:

2023-506359-68-00

Protocol code:

IRIS, D3466C00001

NCT ID:

NCT05138133

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Anifrolumab for Adults with Active Lupus Nephritis

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