Study on Corticosteroids, Dapagliflozin, and Drug Combination for Proteinuria in IgA Nephropathy Patients with Active or Chronic Kidney Lesions

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What is this study about?

This clinical trial is focused on studying a kidney disease called Immunoglobulin A Nephropathy (IgAN), which affects the kidneys’ ability to filter waste from the blood. The study aims to evaluate different treatment approaches for patients with this condition. One part of the study will look at the effects of starting treatment with corticosteroids early, compared to the standard care of using medications called Renin-Angiotensin System Blockers (RASBs) followed by corticosteroids. Another part of the study will compare the combination of a medication called Dapagliflozin with RASBs against corticosteroids combined with RASBs for patients with more chronic kidney issues.

Participants in the study will receive one of the treatments being tested, which may include medications like Ramipril, Losartan, Methylprednisolone, Prednisone, or Dapagliflozin. Some participants may receive a placebo. The study will observe the effects of these treatments on the amount of protein in the urine, which is a sign of kidney damage, and on kidney function over time. The study will last for several months, with regular check-ups to monitor the participants’ health and the effectiveness of the treatments.

The purpose of this study is to find out which treatment approach is more effective in reducing protein levels in the urine and improving kidney function in patients with IgAN. By comparing these different treatments, researchers hope to provide better care options for people living with this kidney disease.

1 joining the study

Upon joining the study, participants will be assigned to one of two groups based on their kidney biopsy results. This assignment is random and helps ensure the study’s reliability.

2 treatment for active renal lesions

Participants with active renal lesions will receive early treatment with corticosteroids after their kidney biopsy. This involves taking prednisone orally. The dosage and frequency will be determined by the study team based on individual needs.

The goal is to evaluate the effect of early corticosteroid therapy on reducing protein levels in the urine.

3 standard care for active renal lesions

Participants in the standard care group will initially receive RASBs (renin-angiotensin system blockers), which may include medications like ramipril or losartan. These are taken orally as per clinical practice.

After a period, corticosteroids will be added to the treatment to assess their combined effect on protein levels in the urine.

4 treatment for chronic or moderate renal lesions

Participants with chronic or moderate renal lesions will receive a combination of SGLT2i (sodium-glucose cotransporter 2 inhibitor) and RASBs. The SGLT2i used in this study is dapagliflozin, taken orally.

The aim is to compare the effect of this combination on protein levels in the urine with the effect of corticosteroids combined with RASBs.

5 monitoring and follow-up

Throughout the study, participants will have regular check-ups to monitor their kidney function and protein levels in the urine. This includes blood tests and urine tests.

The primary goal is to observe changes in protein levels over time, with specific assessments at 4, 8, and 10 months, depending on the group assignment.

6 long-term evaluation

Participants will be followed for up to three years to assess the long-term effects of the treatments on kidney function. This includes measuring the rate of decline in kidney function and any significant changes in protein levels.

The study aims to determine the most effective treatment strategy for managing protein levels and preserving kidney function in patients with IgA nephropathy.

Who Can Join the Study?

Men and women aged 18 to 75 years can participate.
You must provide a signed consent form to show you understand the study and agree to participate.
You need to have a kidney biopsy that shows you have idiopathic IgA nephropathy (IgAN). This means a kidney test confirms the condition.
Your kidney function, measured by a test called eGFR, should be at least 30 ml/min/1.73 m². This test checks how well your kidneys are working.
Your urine protein level, measured over 24 hours, should be at least 0.5 grams. This checks for protein in your urine, which can indicate kidney issues.
You should be currently receiving or be a candidate for treatment with RASBs (either an ACEi or ARB). These are medications used to treat kidney conditions, as recommended by current guidelines.

Who Cannot Join the Study?

Patients with any other kidney disease besides Idiopathic IgA nephropathy (IgAN) cannot participate.
Patients who have had a kidney transplant are not eligible.
Patients with severe kidney damage that cannot be reversed are excluded.
Patients who are currently taking part in another clinical trial cannot join this study.
Patients with a history of severe allergic reactions to the study medications are not allowed.
Pregnant or breastfeeding women cannot participate in the trial.
Patients with uncontrolled high blood pressure are excluded.
Patients with severe liver disease cannot take part in the study.
Patients with a history of drug or alcohol abuse in the past year are not eligible.
Patients with any condition that the study doctors believe would make it unsafe for them to participate are excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Ente Ecclesiastico Ospedale Generale Regionale Miulli	Acquaviva Delle Fonti	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Azienda Ospedaliera di Perugia	Perugia	Italy

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
ARNAS Civico Di Cristina Benfratelli	Palermo	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Ospedale Santa Maria Goretti Latina	Latina	Italy
Ospedale Santa Maria Annunziata	Bagno A Ripoli	Italy
Azienda Sanitaria Locale Viterbo	Viterbo	Italy
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate	Chieti	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Central Hospital Of Bolzano	Bolzano	Italy
Ospedale San Giovanni Bosco	Turin	Italy
Sandro Pertini Hospital	Rome	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Alessandro Manzoni Hospital	Lecco	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
ARNAS G. Brotzu	Cagliari	Italy
Azienda USL Toscana Sud Est	Arezzo	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Ospedale “Morgagni – Pierantoni” di Forlì	Forli'	Italy
Arjbkcz Oosmxrzsciy Ubfajuxoquugl Pwwcs	Parma	Italy
Ucyvzafwzp Dcfcg Sedpk Dx Rcym Li Seizyrqn	Rome	Italy
Ozehilwr Sferk Mrcnr dcbhy Czmqc	Ravenna	Italy
Aplgwor Oksjkphapngsurlsvswhprinw Ds Cscpcpj	Cosenza	Italy
Oppwfxfv Swzjg Mxbmk dnino Mwhjvjgqlrte	Udine	Italy
Axc Rwirww &ntazqw Ohxknrwt Mncaddrz Mmbdaf	Modica	Italy
Pfesrdmn Oaecthsxsyi Aqaoqgb Pfvvxhs	Brindisi	Italy
Aku Robi 3 &vkwwlt Pwspdpiw Onxufgsxven Gxbx Gmyljt	Ostia Lido (Roma)	Italy
Ofyqrsno Iddqjrh dk Rshhoa	Rimini	Italy
Psubvsiz Okascmjjyzj Mopqa Sp Avkedksaos	Eboli	Italy
Aeqgvwo Oubpejzhhjg Pia Lcktqsebqhirnugzv Cmyvaparqx	Catania	Italy
Agwtmke Oamlzdlpkuc Ulfgzdpwmetgr Obpxhiux Rtkbfmr	Foggia	Italy
Acfgbnb Ucd Iwxam Dk Rooxiw Embqwk	Reggio Emilia	Italy
Ayvbljn Uwbgc Snaokaomm Laqpvm Dn Biczbjm	Bologna	Italy
Ubgqizwnpx Mwihd Ghmvevu Oh Cncuxyslh	Catanzaro	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	21.03.2023

Trial locations

Investigated drugs:

Corticosteroids are a type of medication that helps reduce inflammation in the body. In this clinical trial, they are used to treat patients with Immunoglobulin A Nephropathy (IgAN), a kidney disease. The goal is to see if starting corticosteroid treatment early, right after a kidney biopsy, can help reduce protein levels in the urine for patients with active kidney problems.

RASBs, or Renin-Angiotensin System Blockers, are medications that help control blood pressure and protect the kidneys. In this trial, they are used as part of the standard care for IgAN patients. The study aims to compare the effects of using RASBs alone followed by corticosteroids, against starting corticosteroids early, to see which approach is more effective in reducing protein in the urine.

Dapagliflozin is a medication that belongs to a group called SGLT2 inhibitors. It helps lower blood sugar levels and can also have protective effects on the kidneys. In this trial, Dapagliflozin is combined with RASBs to see if this combination can reduce protein in the urine and improve kidney function in patients with chronic kidney problems, compared to using corticosteroids with RASBs. The aim is to find a treatment that avoids the potential side effects of corticosteroids.

Investigated diseases:

IgA nephropathy

Idiopathic IgA nephropathy (IgAN) – Idiopathic IgA nephropathy is a kidney disease characterized by the buildup of the antibody immunoglobulin A (IgA) in the kidneys. This accumulation leads to inflammation that can affect the kidneys’ ability to filter waste from the blood. The disease often progresses slowly over many years. In its early stages, it may not cause noticeable symptoms, but as it advances, it can lead to blood or protein in the urine, swelling in the hands and feet, and high blood pressure. Over time, the persistent inflammation can result in chronic kidney damage. The progression of the disease varies among individuals, with some experiencing stable kidney function for years, while others may develop more severe kidney impairment.

Trial ID:

2024-517861-18-00

NCT ID:

NCT04662723

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Corticosteroids, Dapagliflozin, and Drug Combination for Proteinuria in IgA Nephropathy Patients with Active or Chronic Kidney Lesions

What is this study about?

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