Study on the Effectiveness and Safety of Sparsentan and Dapagliflozin for Patients with Immunoglobulin A Nephropathy (IgAN)

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a medication called Sparsentan for treating a kidney disease known as Immunoglobulin A Nephropathy (IgAN). IgAN is a condition where a protein called immunoglobulin A builds up in the kidneys, leading to inflammation and potential kidney damage. The study aims to see how well Sparsentan can reduce protein levels in the urine and help maintain kidney function compared to another type of medication called an angiotensin receptor blocker (ARB), which is commonly used to treat high blood pressure and kidney issues.

Participants in the study will be randomly assigned to receive either Sparsentan or an ARB. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are not biased. The study will also include a period where participants can receive Sparsentan openly, allowing researchers to assess its long-term effects. Additionally, some participants may be involved in a sub-study to evaluate the combination of Sparsentan with another medication called Dapagliflozin, which is used to manage blood sugar levels in people with diabetes.

The trial will monitor changes in the amount of protein in the urine and kidney function over time. Participants will take the medication in tablet form by mouth. The study will last for several months, with regular check-ups to ensure the safety and effectiveness of the treatment. The goal is to gather information that could lead to better treatment options for people with IgAN.

1 joining the study

Upon joining the study, participation begins in the double-blind period. This means neither the patient nor the researchers know which treatment is being administered. The study focuses on the treatment of Immunoglobulin A Nephropathy (IgAN).

2 double-blind period

During this period, the patient receives either sparsentan or an angiotensin receptor blocker (ARB) in tablet form, taken orally. The specific dosage and frequency are determined by the study protocol.

The primary goal is to assess the effect of sparsentan on protein levels in urine and kidney function. Safety and tolerability are also monitored.

3 monitoring and assessments

Regular assessments are conducted to monitor changes in urine protein levels and kidney function. Blood pressure and other vital signs are also checked.

The primary efficacy endpoint is the change in the urine protein/creatinine ratio at Week 36.

4 open-label extension period

If the patient completes the double-blind period, they may enter the open-label extension period. Here, all patients receive sparsentan, and both the patient and researchers know the treatment being administered.

The focus is on long-term efficacy, safety, and tolerability of sparsentan.

5 sparsentan + SGLT2 inhibitor sub-study

Eligible patients may participate in a sub-study involving sparsentan and an SGLT2 inhibitor, such as dapagliflozin. This involves additional monitoring and assessments.

The sub-study aims to further evaluate the combination’s effect on urine protein levels and kidney function.

6 end of study

The study is estimated to conclude by July 28, 2026. Final assessments will be conducted to evaluate the long-term effects of the treatment.

Who Can Join the Study?

Must be a male or female aged 18 years or older.
Must have a confirmed diagnosis of Immunoglobulin A Nephropathy (IgAN) through a kidney biopsy.
Must have a urine protein excretion value of at least 1.0 grams per day at the start of the study. This means the amount of protein in the urine is measured to be 1.0 grams or more each day.
Must have an eGFR value of at least 30 mL/min/1.73 m² at the start of the study. eGFR is a test that measures how well the kidneys are working.
Must have been on a stable dose of ACEI (Angiotensin-Converting Enzyme Inhibitor) and/or ARB (Angiotensin Receptor Blocker) therapy for at least 12 weeks before the study starts. These are types of medications used to treat high blood pressure and kidney problems.
Must have a systolic blood pressure of 150 mmHg or lower and a diastolic blood pressure of 100 mmHg or lower at the start of the study. Systolic blood pressure is the top number, and diastolic is the bottom number in a blood pressure reading.
Women of childbearing potential must agree to use two forms of contraception to prevent pregnancy during the study.
Must be willing and able to provide signed informed consent to participate in the study. This means agreeing to join the study after understanding all the details and risks involved.
For the Open-Label Extension Period, the patient must not have permanently stopped taking the study medication during the initial study period.
For the Open-Label Extension Period, the patient must have completed participation in the initial study period, including specific visits at Week 110 and Week 114.
For the Sparsentan + SGLT2 Inhibitor Sub-study, the patient must have a urine protein excretion value of at least 0.3 grams per day.
For the Sparsentan + SGLT2 Inhibitor Sub-study, the patient must have an eGFR of at least 25 mL/min/1.73 m².
For the Sparsentan + SGLT2 Inhibitor Sub-study, the patient must be on a stable dose of sparsentan for at least 8 weeks at the maximum tolerated dose.
For the Sparsentan + SGLT2 Inhibitor Sub-study, the patient must have at least 12 weeks of the study remaining.
For the Sparsentan + SGLT2 Inhibitor Sub-study, the patient must meet local requirements and not have any reasons that would prevent them from taking dapagliflozin, a type of medication.

Who Cannot Join the Study?

Patients who have a different kidney condition other than Immunoglobulin A Nephropathy (IgAN) cannot participate. IgAN is a disease that affects the kidneys.
Patients who are not within the specified age range for the study cannot participate. The study is looking for participants within certain age groups.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a kidney transplant cannot participate.
Patients who have a history of allergic reactions to the study medication cannot participate.
Patients who have uncontrolled high blood pressure cannot participate.
Patients who have severe liver disease 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
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Poliklinika Vlatka Cavka d.o.o.	Zagreb	Croatia
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
University Hospital Jena KöR	Jena	Germany
Hospital Clinico San Carlos	Madrid	Spain
CHU Grenoble Alpes	La Tronche	France
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Barmherzige Brueder Trier gGmbH	Trier	Germany
University Hospital Sveti Duh	Zagreb	Croatia
Universitaetsklinikum Aachen AöR	Aachen	Germany
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Hospital Beatriz Angelo	Loures	Portugal
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Hospital De Sagunto	Sagunto	Spain
Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen	Hanover	Germany
Istituto Di Ricerche Farmacologiche Mario Negri	Ranica	Italy
Wojewodzki Szpital Specjalistyczny W Olsztynie	Olsztyn	Poland
Fundacio Puigvert	Barcelona	Spain
KBC Zagreb	Zagreb	Croatia
Clinical Medical Center Osijek	Osijek	Croatia
Scm Sp. z o.o.	Cracow	Poland
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Tartu University Hospital	Tartu	Estonia
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Sint-Lucas General Hospital	Brugge	Belgium
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Alessandro Manzoni Hospital	Lecco	Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Laane-Tallinna Keskhaigla AS	Pohja-Tallinna Linnaosa	Estonia
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Poliklinika Solmed d.o.o.	Zagreb	Croatia
Hopital Beaujon	Clichy	France
North Estonia Medical Centre Foundation	Tallin	Estonia
Nephrologisches Zentrum Villingen-Schwenningen GbR	Villingen-Schwenningen	Germany
Dliner Cziejgch Rpvahwuw Daojvsfjfvg Guhv	Duesseldorf	Germany
Sogxigntwpzozlk Cxnycle Mpsuhwro Eijfzvxh Cummytckoxx Ecjrpc Sae jd	Lodz	Poland
Mcxglksbaxq Sclfbso Sxcodsqlgaktoqj W Wbbusyubx	Warsaw	Poland
Adwurakyqi Pnzjfhnt Hzoeivue Dz Mkbyouzcg	Marseille	France
Aeordfd Ovycetcuiqq Upbmzqrmuvvvy Camzssassbtp Dbatm Saaarg E Dhlbl Sjzjifz Dc Tvxsds	Turin	Italy
Izdpqeld dr Csecnbmwgwyp Hmlabyesnah Uznihphdmjkox dx Sugrt Ectdcql (jgcsquj	Saint Priest En Jarez	France
Hfbkikkc Vyrh dbxwcbdx	Barcelona	Spain
Cpegycqe Hplmnoho Dvgjoch	Zagreb	Croatia

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	11.02.2019
Croatia	Not recruiting	11.02.2019
Czechia	Not recruiting	11.02.2019
Estonia	Not recruiting	11.02.2019
France	Not recruiting	11.02.2019
Germany	Not recruiting	11.02.2019
Italy	Not recruiting	11.02.2019
Lithuania	Not recruiting	11.02.2019
Poland	Not recruiting	11.02.2019
Portugal	Not recruiting	11.02.2019
Spain	Not recruiting	11.02.2019

Trial locations

Investigated drugs:

Sparsentan is a medication being studied for its ability to reduce protein levels in the urine and help preserve kidney function in patients with Immunoglobulin A Nephropathy (IgAN). The study aims to evaluate how well sparsentan works in comparison to another type of medication known as an angiotensin receptor blocker (ARB). Additionally, the study will monitor the safety and tolerability of sparsentan over time, both in a controlled setting and in an open-label phase where all patients receive sparsentan.

Investigated diseases:

IgA nephropathy

Immunoglobulin A Nephropathy (IgAN) – This is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys, leading to inflammation that can affect the kidneys’ ability to filter waste from the blood. Over time, this buildup can cause damage to the glomeruli, the tiny filtering units within the kidneys. 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 blood and protein in the urine, high blood pressure, and swelling in the hands and feet. The progression of IgAN can vary significantly among individuals, with some experiencing only mild symptoms while others may develop more severe kidney damage.

Trial ID:

2023-505495-30-00

Protocol code:

021IGAN17001

NCT ID:

NCT03762850

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Sparsentan and Dapagliflozin for Patients with Immunoglobulin A Nephropathy (IgAN)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?