Istituto / centro clinico aldo e cele Daccò

Ongoing projects

   

Non-diabetic Proteinuric Chronic Kidney Diseases

ADAPT (NCT04794517): “Evaluating the Short-term Renal and Systemic Effects of Dapagliflozin in Non-diabetic Patients with Stage IV CKD at Risk of ESKD Because of Severe Renal Insufficiency and Persistent Proteinuria: A Prospective, Randomized, Double-blind, Placebo-controlled, Cross-over Study”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: AstraZeneca S.p.A.

DROP (NCT05786469): “A prospective, Double-blind, randomized, single Centre Trial to evaluate the rate of RASS Inhibitor withdrawal or down-titration in non-dialysis patients with CKD stage IIIB to V randomized to patiromer or placebo”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: Vifor Pharma

FIND-CKD (NCT05047263): “A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease”

Sponsor: Bayer AG        

Funding: Bayer AG

Immunoglobulin A Nephropathy (IgA)

PROTECT (NCT03762850): “A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy”

Sponsor: TRAVERE THERAPEUTICS (RETROPHIN Inc)            

Funding: TRAVERE THERAPEUTICS (RETROPHIN Inc)

BEYOND (NCT05852938): “A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy”

Sponsor: Chinook Therapeutics, Inc.

Funding: Chinook Therapeutics, Inc.

Membranous Nephropaty (MN)

ORION (NCT05050214): “Obinutuzumab for primary membranous nephropathy: a pilot study in patients with rituximab-resistant or rituximab-dependent nephrotic syndrome and in patients intolerant to rituximab”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: Roche S.p.A.

MONET (NCT04893096): “Rescue Therapy with the Human Anti-CD38 Antibody MOR202 (Felzartamab) in Patients with Membranous Nephropathy Who Failed Anti-CD20 Target Therapy”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: Hi-Bio

PEPTIDE (NCT04095156): “PLA2R autoreactive B-Cell subsets and Immune cell monitoring in membranous nephropathy: identification of outcome predictors and novel insights into disease pathogenesis”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

PROMENADE (NCT06242327): “An Observational, Longitudinal Study to Describe the Outcome, and Outcome predictors, of Patients with Primary Membranous Nephrophaty Treated as per Center Clinical Practice Because of Nephrotic Syndrome Onset”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Membranoprolipherative Glomerulonephritis (MPGN) e C3 Glomerulopathy (C3G)

DECODE: “Defining stratification of patients with C3 Glomerulopathies/immune complex mediated glomerular diseases for better diagnosis and tailored treatment”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: ERA Permed JTC 2020

UNEARTH: “A thorough understanding of the molecular players causing rare complement-mediated glomerular diseases toward a personalized therapy”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: Fondazione Regionale per la Ricerca Biomedica (FRRB) Early Career Award

“The molecular mechanisms underlying complement dysregulation by nephritic factors in C3 glomerulopathy (C3G) and their impact on treatment”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: Kidneeds

APPEAR-C3G (NCT04817618): “A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy (CLNP023B12301)”

Sponsor: Novartis Farma AG    

Funding: Novartis Farma AG

APPEAR-C3G extension (NCT03955445): “An open-label, non-randomized extension study to evaluate the long-term efficacy, safety and tolerability of LNP023 in subjects with C3 glomerulopathy”

Sponsor: Novartis Farma AG    

Funding: Novartis Farma AG

NOBLE (NCT04572854): “An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN (APL2-C3G-204)

Sponsor: Apellis Pharmaceuticals, Inc.              

Funding: Apellis Pharmaceuticals, Inc.              

VALIANT (NCT05067127): “A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - APL2-C3G-310”

Sponsor: Apellis Pharmaceuticals, Inc.              

Funding: Apellis Pharmaceuticals, Inc.

VALE (NCT05809531): “An open-label, nonrandomized, multicenter extension study to evaluate the long-term safety and efficacy of pegcetacoplan in participants with C3 glomerulopathy or immune-complex membranoproliferative glomerulonephritis”

Sponsor: Apellis Pharmaceuticals, Inc.              

Funding: Apellis Pharmaceuticals, Inc.

APPARENT (NCT05755386): “A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN) (CLNP023B12302)”

Sponsor: Novartis Farma AG    

Funding: Novartis Farma AG

CPV-104/C3G: “Proposal to test the efficacy of recombinant factor H, CPV-104, to antagonize alternative pathway C3 convertase stabilization by C3NEFs from patients with primary C3G”

Sponsor: Eleva GmbH

Funding: Eleva GmbH

COMPRare (NCT05985122): “Towards the most accurate diagnosis and monitoring of Complement-mediated rare kidney diseases”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: EJP RD Call for Proposals 2022

LNP023IC-MPGN: “Proposal to test the efficacy of factor B inhibitor, Iptacopan, to clock the activation of the complement alternative pathway in serum from patients with primary IC-MPGN”

Sponsor: Novartis Farma AG

Funding: Novartis Farma AG

Nephrotic Syndromes (NS)

PARSEC: “Study of the pathogenetic mechanisms underlying post-transplant disease recurrence in patients with idiopathic focal segmental glomerulosclerosis”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

BLADE (NCT05712369): “Phenotype and Function of Reconstituting B-cells in Steroid Dependent or Frequently Relapsing Nephrotic Syndrome After B-cell Depletion: Insight into the Disease Pathogenesis and Identification of Predictors of Relapse”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

BLINDer (NCT06334692): “Autoantibodies against-nephrin in idiopathic nephrotic syndrome”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Non-proteiunuric Chronic Kidney Diseases

REORIENTED (NCT05646420): “Deciphering the role of thyroid hormones in autosomal dominant polycystic kidney disease”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

ADPKD648 (NCT06193616): “Evaluating Baseline Predictors, Including Total Kidney Volume, of Chronic GFR decline and other Clinical Outcomes in Outpatients with ADPKD and Stage IV CKD on Chronic Treatment with Ocreotide Long-Acting Release: Restrospective, Observational Study”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Thrombotic Microangiopathies

aHUS-iPSC-EC (NCT05805202): “Functional implications of rare gene mutations in aHUS open the door to personalized therapy”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: EU PNRR-MR1-2022-12375758

COMPRare (NCT05985122): “Towards the most accurate diagnosis and monitoring of Complement-mediated rare kidney diseases”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: EJP RD Call for Proposals 2022

Image analysis in kidney diseases and therapy response

RESPECT (NCT05229263): “Exploratory multicentre clinical study to assess repeatability, reproducibility, acceptability and clinical validity of multiparametric renal magnetic resonance imaging”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: ERA Permed JTC 2020

Undiagnosed Rare Diseases

ANTHEM-RNA-Seq (NCT05996731): “Developing a pipeline to employ RNA-Seq as a complementary diagnostic tool in rare diseases”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS      

Funding: National Plan for NRRP Complementary Investments

Collection of medical images for future research

MEDICALBUM (NCT06354829): “Creation of a collection of medical images to facilitate their use for future not-for-profit research”

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

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