Study on the Effects of Sparsentan and Irbesartan for Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Sparsentan on a kidney disease known as Focal Segmental Glomerulosclerosis (FSGS). FSGS is a condition that affects the kidney’s filtering units, leading to scarring and potential kidney damage. The study aims to evaluate how well Sparsentan can protect the kidneys over a long period and to assess its safety for patients with this disease.

Participants in the study will receive either Sparsentan or another medication called Irbesartan, which is commonly used to treat high blood pressure and kidney problems. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving which medication during the trial. This helps ensure that the results are unbiased. The trial will also include an “open-label” phase, where all participants will receive Sparsentan to further assess its long-term effects.

The study will take place over several years, with regular check-ups to monitor kidney function and overall health. Participants will take the medication in tablet form by mouth. The goal is to determine if Sparsentan can effectively reduce the progression of kidney damage in FSGS patients compared to Irbesartan, while also ensuring that it is safe and well-tolerated.

1 double-blind period

During this phase, the patient will receive either sparsentan or irbesartan in tablet form. Both medications are taken orally.

The purpose of this phase is to compare the effects of sparsentan with irbesartan on kidney function in patients with primary focal segmental glomerulosclerosis (FSGS).

The patient will be monitored for changes in kidney function and protein levels in the urine over approximately two years.

2 medication administration

The patient will take the assigned medication daily. The dosage and specific instructions will be provided by the study team.

Regular check-ups will be scheduled to monitor the patient’s health and response to the medication.

3 safety and efficacy assessments

Throughout the double-blind period, the patient’s kidney function will be assessed by measuring the estimated glomerular filtration rate (eGFR) and protein levels in the urine.

Safety assessments will include monitoring for any side effects or adverse reactions to the medication.

4 open-label extension period

After completing the double-blind period, the patient may enter the open-label extension phase if they meet specific criteria.

In this phase, all patients will receive sparsentan to further evaluate its long-term effects on kidney function and overall health.

5 ongoing monitoring

During the open-label extension, the patient’s kidney function, protein levels in the urine, and overall health will continue to be monitored.

Additional assessments will include changes in quality of life, body weight, vital signs, and laboratory parameters.

Who Can Join the Study?

The patient or their parent/legal guardian must be willing and able to provide signed informed consent or assent, which means they agree to participate in the study after understanding what it involves.
The patient must have a confirmed diagnosis of Focal Segmental Glomerulosclerosis (FSGS), which is a kidney condition. This can be proven by a past biopsy or genetic test showing a mutation in a specific kidney cell protein.
The patient must be between 18 and 75 years old and weigh at least 20 kg (about 44 pounds) at the time of screening. Patients under 18 may be included only in the United States and United Kingdom.
The patient must have a urine protein to creatinine ratio (UP/C) of at least 1.5 g/g (170 mg/mmol) at screening. This is a measure of protein in the urine, which helps assess kidney function.
The patient must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m² at screening. This is a test to check how well the kidneys are working.
The patient’s average seated blood pressure must be between 100/60 mmHg and 160/100 mmHg. This is a measure of the force of blood against the walls of the arteries.
Women of childbearing potential (WOCBP) must agree to use contraception and undergo pregnancy testing as described in the study protocol.
For the open-label extension period, the patient must have completed participation in the double-blind period, including the Week 112 visit.
For the open-label extension period, the patient or their parent/legal guardian must be willing and able to provide signed informed consent for participation.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Focal Segmental Glomerulosclerosis (FSGS) cannot participate. FSGS is a condition that affects the kidneys.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are taking medications that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of drug or alcohol abuse cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who have allergies to the study medication cannot participate.
Patients who have a history of non-compliance with medical treatments cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hopital Necker Enfants Malades	Paris	France
Medizinische Hochschule Hannover	Hanover	Germany
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Hospital Clinico San Carlos	Madrid	Spain
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Katholieke Universiteit te Leuven	Leuven	Belgium
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Centre hospitalier universitaire de Liege	Liege	Belgium
Robert Bosch Krankenhaus GmbH	Stuttgart	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Hospital Beatriz Angelo	Loures	Portugal
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Eb Group Sp. z o.o.	Warsaw	Poland
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Centre Hospitalier De Valenciennes	Valenciennes	France
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.	Olsztyn	Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Tartu University Hospital	Tartu	Estonia
Karolinska University Hospital	Solna	Sweden
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Laane-Tallinna Keskhaigla AS	Pohja-Tallinna Linnaosa	Estonia
Centre Hospitalier Universitaire De Nice	Nice	France
Centro Hospitalar de Setubal E.P.E.	Setubal	Portugal
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen	Germany
Hopital Beaujon	Clichy	France
Servei De Salut De Les Illes Balears	Palma	Spain
North Estonia Medical Centre Foundation	Tallin	Estonia
Dajsge Cutaqqzo Rfdydygm Doscpybtfdt Gair	Duesseldorf	Germany
Mfaqbsqfkxx Sffxfcj Sxcykqtbsgtwcnm W Wygcywwec	Warsaw	Poland
Spnloadithgmcmq Chyvanr Mrpvyhfq Eqbdskdg Czzakttznaf Ekaehl Sps jk	Lodz	Poland
Aqvoeckvwd Phcxkwfg Hhaflpia Du Mfglxegan	Marseille	France
Adsqmbp Uprre Sdzmcldjv Lcxjzm Dn Bffqucy	Bologna	Italy
Iejlgbpx dq Cunejvhfjblj Hazwpxzeklf Ugbrayntvmwnj dv Sfuts Euxprkp (laxenwm	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.03.2018
Croatia	Not recruiting	01.03.2018
Czechia	Not recruiting	01.03.2018
Denmark	Not recruiting	01.03.2018
Estonia	Not recruiting	01.03.2018
France	Not recruiting	01.03.2018
Germany	Not recruiting	01.03.2018
Italy	Not recruiting	01.03.2018
Poland	Not recruiting	01.03.2018
Portugal	Not recruiting	01.03.2018
Spain	Not recruiting	01.03.2018
Sweden	Not recruiting	01.03.2018

Trial locations

Investigated drugs:

Sparsentan is a medication being studied for its potential to protect the kidneys in patients with a condition called primary Focal Segmental Glomerulosclerosis (FSGS). It works by blocking two types of receptors in the body: endothelin receptors and angiotensin receptors. This dual action is thought to help reduce kidney damage and improve kidney function over time. The study aims to evaluate how effective sparsentan is in providing long-term kidney protection and to monitor its safety and tolerability in patients with FSGS.

Investigated diseases:

Focal segmental glomerulosclerosis

Focal Segmental Glomerulosclerosis (FSGS) – FSGS is a kidney disorder characterized by scarring in the glomeruli, which are tiny structures within the kidneys that filter waste from the blood. This scarring can lead to a loss of kidney function over time. The disease can be primary, with no known cause, or secondary, resulting from another condition. Symptoms often include proteinuria, where excess protein is found in the urine, and swelling in parts of the body due to fluid retention. As the disease progresses, it can lead to chronic kidney disease. FSGS is considered a rare disease and can affect both children and adults.

Trial ID:

2023-505494-32-00

Protocol code:

021FSGS16010

NCT ID:

NCT03493685

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Sparsentan and Irbesartan for Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?