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)

APPLAUSE(NCT04578834): “A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients
Sponsor: Novartis Farma AG
Funding: Novartis Farma AG

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

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

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

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

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

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

STEC-SEU: “Molecular determinants of STEC-HUS: from complement activation to microvascular thrombosis”
Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

CPV-104 aSEU: “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: Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Funding: ELEVA Biologics

Analisi di immagini nelle malattie renali e nella risposta alla terapia

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

Open-label extension study to assess the long-term efficacy, safety, and tolerability of LNP023 in subjects with C3 glomerulopathy (CLNP023B12001B)

Sponsor: Novartis Farma AG

Funding: Novartis Farma AG

Multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in C3 glomerulopathy (CLNP023B12301) - APPEAR C3G

Sponsor: Novartis Farma AG

Funding: Novartis Farma AG

Randomized, controlled, open-label, 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) - NOBLE

Sponsor: Apellis Pharmaceuticals, Inc.

Funding: Apellis Pharmaceuticals, Inc.

Research on molecular mechanisms underlying rare complement-mediated glomerular diseases to identify personalized therapies (UNEARTH Study)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

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

Research on precise classification of patients with C3 deposition glomerulopathy and immune complex-mediated glomerular diseases for better diagnosis and targeted therapy (DECODE Study)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: ERAPermed JTC 2020

Towards the most accurate diagnosis and monitoring ofComplement-mediated rare kidney diseases.

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Ministero della Salute (bando EJPRD)

 

The molecular mechanisms underlying complementdysregulation by nephritic factors in C3G and IC-MPGN and their impact onclassification and treatment

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Kidneeds

Projects and Clinical Studies on Chronic Kidney Diseases

Evaluation of short-term renal and systemic effects of Dapagliflozin in non-diabetic patients with Stage IV CKD at risk of ESKD due to severe renal failure and persistent proteinuria: a prospective, randomized, double-blind, placebo-controlled, crossover study (ADAPT Study)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: AstraZeneca

Randomized, multicenter, double-blind, parallel-group, active-controlled study of Sparsentan efficacy and safety for the treatment of IgA nephropathy (PROTECT Study)

Sponsor: Retrophin Inc

Funding: Retrophin Inc

Studio prospettico, randomizzato, in doppio cieco, monocentrico, per valutare il tasso di sospensione o riduzione della dose di farmaci inibitori del Sistema Renina-Angiotensina-Aldosterone (SRAA) in pazienti con malattia renale cronica, stadio evolutivo compreso tra IIIb e V, non dializzati trattati con Patiromer o placebo (Studio DROP)

Promotore: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Finanziamento: ViforPharma

Prospective, randomized, double-blind, monocentric study to assess the suspension rate or dose reduction of Renin-Angiotensin-Aldosterone System (RAAS) inhibitors in chronic kidney disease patients, Stage IIIb-V, not on dialysis treated with Patiromer or placebo (DROP Study)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: ERAPermed JTC 2020

Projects and Clinical Studies on membranous nephropathy

Proposal for a study to evaluate the efficacy of MOR202, an anti-CD38 antibody, in patients with membranous nephropathy resistant to anti-CD20 antibody therapy (MONET Study)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Morphosys AG

Proposal for a study to evaluate the efficacy of Obinutuzumab, an anti-CD20 antibody, in patients with membranous nephropathy resistant to Rituximab therapy (ORION Study)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Roche

Monitoring of circulating anti-PLA2R autoreactive B cells and leukocytes in membranous nephropathy: identification of outcome predictors and study of pathogenetic mechanisms (PEPTIDE Study)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Projects and Clinical Studies on Nephrotic Syndrome

Phenotype and function of B cell reconstitution after anti-CD20 therapy in steroid-dependent or frequently relapsing nephrotic syndrome: new insights into disease pathogenesis and identification of relapse predictors (BLADE Study)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Phase 2 open-basket study of atrasentan in patients with proteinuric glomerular diseases (AFFINITY Study)

Sponsor: CHINOOK THERAPEUTICS U.S., Inc.

Funding: CHINOOK THERAPEUTICS U.S., Inc.

Study to identify possible antigens in atypical anti-glomerular basement membrane disease (Anti MBG Study)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Study of pathogenetic mechanisms underlying recurrence of focal segmental glomerulosclerosis in kidney transplant recipients (PARSEC Study)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Projects and Clinical Studies on Rare Undiagnosed Diseases

Rare Diseases without Diagnosis

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

ANTHEM (AdvaNced Technologies for Human-centrEd Medicine)

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: European Community (PNRR)

Projects and Clinical Studies on Hemolytic Uremic Syndrome (HUS)

Functional implications of rare genemutations in atypical hemolytic uremic syndrome open the door to personalizedtherapy.

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Comunità Europea (PNRR)

 

Towards the most accurate diagnosis and monitoring ofComplement-mediated rare kidney diseases.

Sponsor: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Funding: Ministero della Salute (bando EJPRD)

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