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
