Study on the Effects of Povetacicept for Adults 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). This condition affects the kidneys and can lead to kidney damage over time. The study will test a treatment called Povetacicept Injection, which is given as a solution for injection under the skin. The purpose of the study is to see how effective Povetacicept is in reducing the amount of protein in the urine and in preserving kidney function compared to a placebo.

Participants in the study will receive either the Povetacicept Injection or a placebo. The study will last for a total of 104 weeks, which is about two years. During this time, participants will have regular check-ups to monitor their kidney function and the amount of protein in their urine. The study aims to see if Povetacicept can help slow down the progression of kidney disease in people with IgAN.

Throughout the study, participants will be closely monitored to ensure their safety and to gather information on how well the treatment is working. The results of this study could provide valuable insights into new treatment options for people living with Immunoglobulin A Nephropathy.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as a diagnosis of Immunoglobulin A Nephropathy (IgAN) and certain kidney function measurements.

You will receive detailed information about the study, including the purpose, procedures, and potential risks and benefits. You will have the opportunity to ask questions and provide informed consent to participate.

2 baseline assessments

Baseline assessments will be conducted to gather initial data. These assessments may include blood tests, urine tests, and measurements of kidney function.

The results will serve as a reference point to evaluate changes during the study.

3 randomization

You will be randomly assigned to receive either the study medication, povetacicept, or a placebo. A placebo is a substance with no active ingredients, used to compare the effects of the study medication.

This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

4 treatment phase

During the treatment phase, you will receive povetacicept or placebo through a subcutaneous injection (an injection under the skin).

The injections will be administered according to the study schedule, which will be explained to you in detail. The treatment phase will last up to 104 weeks.

5 regular follow-up visits

You will attend regular follow-up visits to monitor your health and the effects of the treatment. These visits will include assessments similar to the baseline assessments.

The frequency of these visits will be outlined in the study schedule provided to you.

6 end of treatment assessments

At the end of the treatment phase, final assessments will be conducted to evaluate the effects of the study medication on your condition.

These assessments will help determine the efficacy of povetacicept in reducing protein levels in urine and preserving kidney function.

7 study completion

After completing the study, you will receive information about the overall results and any next steps regarding your health care.

Your participation will contribute to understanding the treatment of Immunoglobulin A Nephropathy.

Who Can Join the Study?

Must have a diagnosis of Immunoglobulin A Nephropathy (IgAN), confirmed by a kidney biopsy.
Must have a 24-hour urine protein excretion of at least 1.0 gram per day, or a 24-hour urine protein-to-creatinine ratio (uPCR) of at least 0.75 grams per gram.
Must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73m². This is a measure of how well the kidneys are filtering blood.
Must be on a stable dose of an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), which are types of medications used to treat high blood pressure and kidney problems.
Both males and females are eligible to participate.
Participants must be within the specified age range for the study.

Who Cannot Join the Study?

Patients with any other kidney disease besides Immunoglobulin A Nephropathy cannot participate.
Patients who have had a kidney transplant are not eligible.
Patients with severe liver disease cannot join the study.
Patients with uncontrolled high blood pressure are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of cancer in the last 5 years are not eligible.
Patients with a known allergy to the study medication cannot join.
Patients who are currently participating in another clinical trial are excluded.
Patients with a history of drug or alcohol abuse in the last year cannot participate.
Patients with any serious medical condition that might interfere with the study are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oslo Universitetssykehus HF	Oslo	Norway
Hopital Necker Enfants Malades	Paris	France
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Pauls Stradins Clinical University Hospital	Riga	Latvia
Danderyds Sjukhus AB	Danderyd	Sweden
Region Oestergoetland	Linkoping	Sweden
Universitaetsklinikum Aachen AöR	Aachen	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
University Hospital Waterford	Waterford	Ireland
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Centre Hospitalier Du Puy	Le Puy-En-Velay	France
Centre Hospitalier De Valenciennes	Valenciennes	France
Scm Sp. z o.o.	Cracow	Poland
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Tartu University Hospital	Tartu	Estonia
Klinikum St. Georg gGmbH	Leipzig	Germany
Fakultni Nemocnice Brno	Brno	Czechia
Karolinska University Hospital	Solna	Sweden
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH	Feldkirch	Austria
University Hospital Galway	Galway	Ireland
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Aalborg University Hospital	Aalborg	Denmark
Nemocnice AGEL Novy Jicin a.s.	Novy Jicin	Czechia
Centre Hospitalier Universitaire De Nantes	Nantes	France
Vidzemes Slimnica SIA	Valmiera	Latvia
Ziekenhuis Oost Limburg	Genk	Belgium
Rigshospitalet	Copenhagen	Denmark
Poliklinika Solmed d.o.o.	Zagreb	Croatia
University Of Pecs	Pecs	Hungary
Satucon Oy	Kuopio	Finland
Pirkanmaan hyvinvointialue	Tampere	Finland
Hopital Beaujon	Clichy	France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
North Estonia Medical Centre Foundation	Tallin	Estonia
University Of Bordeaux	Talence	France
University Hospital Merkur	Zagreb	Croatia
Ustcuekmwsbs Mixiluy Cwepeve Gefbymnhm	Groningen	The Netherlands
Cfun Upbmkvrkdh Hgvqccvp	Cork	Ireland
Agovzbtxgg Prxdjwtq Hjbdlcjk Dy Mtqytitqw	Marseille	France
Umlfydm Ujqnvkbrxn Hichgeza	Uppsala	Sweden
Hkeyd Bfbnht He	Bergen	Norway
Shfswztul Rqxixne Ubleftyabk Mjzdbly Clvrxw	Nijmegen	The Netherlands
Pnqxwpvey Irdjhtht Mrmmwezp Miqyvqhwxfcg Safdr Wgbjclqiobti I Abkyuwemwfvwq	Warsaw	Poland
Ispdtutk dr Ccbdnwqdmviq Hueszvneogn Uiyogxvkceehy dn Sqahq Eongzbj (bnjipkx	Saint Priest En Jarez	France
Crqttpeq Hletpcue Dfsleaq	Zagreb	Croatia

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.11.2024
Belgium	Not recruiting	01.11.2024
Croatia	Not recruiting	01.11.2024
Czechia	Not recruiting	01.11.2024
Denmark	Not recruiting	01.11.2024
Estonia	Not recruiting	01.11.2024
Finland	Not recruiting	01.11.2024
France	Not recruiting	01.11.2024
Germany	Not recruiting	01.11.2024
Hungary	Not recruiting	01.11.2024
Ireland	Not recruiting	01.11.2024
Italy	Not recruiting	01.11.2024
Latvia	Not recruiting	01.11.2024
Lithuania	Not recruiting	01.11.2024
Norway	Not recruiting	01.11.2024
Poland	Not recruiting	01.11.2024
Spain	Not recruiting	01.11.2024
Sweden	Not recruiting	01.11.2024
The Netherlands	Not recruiting	01.11.2024

Trial locations

Povetacicept is a medication being studied for its potential to help people with a kidney condition called Immunoglobulin A Nephropathy. This condition can cause damage to the kidneys over time. Povetacicept is designed to reduce the amount of protein in the urine, which is a sign of kidney damage. By lowering protein levels in the urine, the medication aims to protect the kidneys and help them function better for a longer period. The study is looking at how well Povetacicept works compared to a placebo, which is a substance with no active medication, to see if it can effectively preserve kidney function in patients with this condition.

Investigated diseases:

Nephropathy

Immunoglobulin A Nephropathy – Immunoglobulin A 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. The disease often progresses slowly over many years. Symptoms may include blood in the urine, protein in the urine, and swelling in the hands and feet. As the disease progresses, it can lead to chronic kidney disease.

Trial ID:

2024-514135-17-00

Protocol code:

AIS-D08

NCT ID:

NCT06564142

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Povetacicept for Adults with IgA Nephropathy

What is this study about?

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