Comparison and evaluation of lupus nephritis response criteria in lupus activity indices and clinical trials.

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Term Occurence Count Dictionary
chronic kidney disease 2 nephrologydiseases
kidney failure 2 nephrologydiseases
lupus nephritis 10 nephrologydiseases
methylprednisolone 1 nephrologydiseasesdrugs
mycophenolate mofetil 3 nephrologydiseasesdrugs
prednisolone 2 nephrologydiseasesdrugs
Belimumab 3 nephrologydiseasesdrugs
nephrotic syndrome 1 nephrologydiseases
prednisone 3 nephrologydiseasesdrugs
rituximab 1 nephrologydiseasesdrugs
cyclophosphamide 5 nephrologydiseasesdrugs

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Select Drug Character Offset Drug Term Instance
Belimumab 25792 Research) trial also assesses the efficacy of abatacept with background therapy of MMF.The BLISS-LN ( Belimumab International Lupus Nephritis Study) trial assesses the efficacy of belimumab—a human monoclonal antibody
Belimumab 27380 CompanyBLISS-LNPhase 3, randomized, double-blind, placebo-controlledIII or IV and coexisting V if present Belimumab versus placeboCorticosteroids + CYC for induction therapyNumber of participants with complete renal
Belimumab 28676 Protein Reduction Active – Lupus with Voclosporin; Longer Against Shorter; AZA, azathioprine; BLISS-LN, Belimumab International Lupus Nephritis Study; CYC, cystatin C; eGFR, estimated glomerular filtration rate; MMF,
cyclophosphamide 1872 Historically, high-dose corticosteroids were the mainstay of treatment for LN, and not until the mid-1980s was cyclophosphamide found to prolong renal survival [[1]]. Subsequently, glucocorticoid therapy and cyclophosphamide became
cyclophosphamide 1969 was cyclophosphamide found to prolong renal survival [[1]]. Subsequently, glucocorticoid therapy and cyclophosphamide became the standard induction regimen. Research has focused on identifying regimens that allow shorter
cyclophosphamide 15412 trials of lupus nephritis: past and presentCompleted trialsGlucocorticoids and intermittent intravenous cyclophosphamide (IVC) have long been considered the standard induction agents to treat LN. Steinberg and Decker [[22]]
cyclophosphamide 15556 considered the standard induction agents to treat LN. Steinberg and Decker [[22]] reported the success of cyclophosphamide when compared with azathioprine (AZA) or placebo for inducing remission over the course of a 10-week
cyclophosphamide 39648 illustrates this point. The earlier uncontrolled trials were of patients who failed initial therapy with cyclophosphamide or MMF, whereas the LUNAR (Lupus Nephritis Assessment with Rituximab) project enrolled patients receiving
methylprednisolone 21689 filtration rate; ESKD, end-stage kidney disease; hpf, high-power field; IV, intravenous; Methylpred, methylprednisolone ; MMF, mycophenolate mofetil; RBC, red blood cell; RRT, renal replacement therapy; SCr, serum creatinine;
mycophenolate mofetil 21714 end-stage kidney disease; hpf, high-power field; IV, intravenous; Methylpred, methylprednisolone; MMF, mycophenolate mofetil ; RBC, red blood cell; RRT, renal replacement therapy; SCr, serum creatinine; UPCR, urinary protein-to-creatinine
mycophenolate mofetil 23112 progressive kidney disease [[29],[30]].The trial that assessed efficacy and safety of adding abatacept to mycophenolate mofetil (MMF) highlights the need to define endpoints carefully [[26]]. The definition of ‘complete response’
mycophenolate mofetil 28789 International Lupus Nephritis Study; CYC, cystatin C; eGFR, estimated glomerular filtration rate; MMF, mycophenolate mofetil ; RBC, red blood cell; TWEAK, tumor necrosis factor-related weak inducer of apoptosis; UPC, urine protein-to-creatinine;
prednisolone 17585 adjusted based on WBC) versus low-dose CYC (500 mg every 2 weeks)Methylpred three times followed by prednisolone taper, maintenance dose 5 to 7.5 mg/day• Treatment failure = one of the following:Similar treatment
prednisolone 21695 filtration rate; ESKD, end-stage kidney disease; hpf, high-power field; IV, intravenous; Methylpred, methyl prednisolone ; MMF, mycophenolate mofetil; RBC, red blood cell; RRT, renal replacement therapy; SCr, serum creatinine;
prednisone 2263 therapies are approved for the treatment of systemic lupus erythematosus (SLE) aside from aspirin, prednisone , hydroxychloroquine, and belimumab. In this review, we will focus on previous and ongoing trials specifically
prednisone 36156 continue to use a step-down design. This involves starting two agents simultaneously (for example, MMF and prednisone ) and then reducing the dose of one agent (in this case, steroids) [[23]]. A treatment with similar efficacy
prednisone 39236 the abatacept trial did not restrict steroid dosing, and the analysis observed a trend of higher mean prednisone dose among the placebo group, confounding interpretation of the data [[26]].Lupus has diverse manifestations,
rituximab 39533 in a more homogeneous patient sample may increase the yield of positive findings. The research into rituximab illustrates this point. The earlier uncontrolled trials were of patients who failed initial therapy
Select Disease Character Offset Disease Term Instance
chronic kidney disease 3917 increasing [[6]]. In addition, renal flares may be an independent predictor of incident and progressive chronic kidney disease (CKD) [[7]]. Patients with lower socioeconomic status have an even worse prognosis [[8]-[10]]. Advances
chronic kidney disease 30183 especially in a diverse group of patients recruited from centers around the world.Surrogate endpoints in chronic kidney disease trialsClinical trials should be centered on improving outcomes that matter to patients. In the case
kidney failure 32410 summarize that review here. By definition, there must be a decrease in GFR for a patient to develop kidney failure , making substantial changes in GFR a reasonable intermediate endpoint for ESKD. However, changes in
kidney failure 34550 presence of or a change in proteinuria, unlike GFR, is not a mandatory intermediary in the development of kidney failure . As a result, proteinuria must be validated as a surrogate endpoint and this has yet to be done [[37]].
lupus nephritis 64 Title: Arthritis Research & TherapyComparison and evaluation of lupus nephritis response criteria in lupus activity indices and clinical trialsKristin M CorapiMary Anne DooleyWilliam
lupus nephritis 671 complication of SLE as it is associated with significant morbidity and mortality. Advancing the treatment of lupus nephritis requires well-designed clinical trials and this can be challenging in SLE. The major obstacles involve
lupus nephritis 1031 measured. In this review, we will first discuss the clinical utility of endpoints chosen to represent lupus nephritis in global disease activity scales. Second, we will review completed and active trials focused on lupus
lupus nephritis 1144 nephritis in global disease activity scales. Second, we will review completed and active trials focused on lupus nephritis and discuss the endpoints chosen. There are many important lessons to be learned from existing assessment
lupus nephritis 1676 end-stage kidney disease (ESKD). Carefully designed trials to identify strategies to calm flares of lupus nephritis (LN) and identify drug regimens to maintain remission are essential. Historically, high-dose corticosteroids
lupus nephritis 4701 non-specific cytotoxic drugs despite the advent of numerous potential biologic agents [[3]].Surveillance of lupus nephritis in clinical nephrologyKidney involvement in SLE is heralded by either the presence of proteinuria (>0.5 g/day),
lupus nephritis 15318 training or complicated scoring will impair utility in clinical use.Renal endpoints in clinical trials of lupus nephritis : past and presentCompleted trialsGlucocorticoids and intermittent intravenous cyclophosphamide (IVC)
lupus nephritis 16667 chosen primary and secondary endpoints.Table 2An overview of landmark randomized controlled trials of lupus nephritis treatments published since 2000ReferenceStudy designNumber of patientsFollow-up, monthsInterventionSteroidsEndpointConclusionInductionChan
lupus nephritis 26495 inflammation—with background therapy of MMF.Table 3An overview of major randomized controlled trials of lupus nephritis treatments currently in progress and their response criteriaClinicalTrials. gov identifierSponsorStudy
lupus nephritis 37929 collection •Analysis of urine sediment only in conjunction with above2.Guidelines for future trials of lupus nephritis : •Complete response should be a composite endpoint of the following: ◦Proteinuria of
nephrotic syndrome 20883 mg/kg per day) or MMF (target 2 g/day)Methylpred three times followed by taper• Time to renal flare = nephrotic syndrome , ≥33% increase in serum creatinine within 1 month, threefold increase in 24-hour proteinuria with

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