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  string(128) "Effects of Canagliflozin on Prioritized Cardiorenal Outcomes: A Hierarchical IPD Meta-analysis of CANVAS, CANVAS-R, and CREDENCE"
  ["project_narrative_summary"]=>
  string(738) "Canagliflozin can reduce heart and kidney complications in people with type 2 diabetes, but standard analyses often focus only on the first event and treat very different outcomes as if they were equally important. We will reanalyze individual participant data from the CANVAS, CANVAS-R, and CREDENCE randomized trials. Participants assigned to canagliflozin will be compared with those assigned to placebo using a prespecified clinical priority order, beginning with death, then major nonfatal heart or kidney events, and then worsening kidney function. This approach will provide an integrated estimate of whether canagliflozin leads to a better overall cardiorenal outcome and will show which components contribute most to that effect."
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  string(29) "WeChat public account article"
  ["principal_investigator"]=>
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    ["first_name"]=>
    string(4) "Dong"
    ["last_name"]=>
    string(5) "Liang"
    ["degree"]=>
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    ["primary_affiliation"]=>
    string(55) "Shandong Medical and Pharmaceutical University Hospital"
    ["email"]=>
    string(21) "liangdong2018@126.com"
    ["state_or_province"]=>
    string(8) "Shandong"
    ["country"]=>
    string(5) "China"
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    ["label"]=>
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  ["property_scientific_abstract"]=>
  string(1492) "Background: Canagliflozin reduces cardiovascular and kidney events in type 2 diabetes, but conventional time-to-first-event composites do not account for differences in clinical importance among components and may discard information after the first event.

Objective: To quantify the prioritized overall cardiorenal effect of canagliflozin using a prespecified hierarchical composite outcome.

Study Design: Post hoc individual participant data meta-analysis of three randomized controlled trials.

Participants: All randomized participants in CANVAS, CANVAS-R, and CREDENCE, analyzed according to randomized treatment assignment.

Primary and Secondary Outcome Measure(s): The primary hierarchy will prioritize (1) all-cause death; (2) time to first major nonfatal cardiorenal event, defined as kidney failure, hospitalization for heart failure, nonfatal myocardial infarction, or nonfatal stroke; and (3) sustained >=40% decline in eGFR. Secondary analyses will evaluate individual components, conventional cardiovascular and kidney composites, and alternative kidney- and cardiovascular-prioritized hierarchies.

Statistical Analysis: Trial-stratified unmatched win statistics will compare canagliflozin with placebo under the intention-to-treat principle. Win ratio, win odds, net benefit, 95% confidence intervals, and tier contributions will be reported. Conventional time-to-event analyses and prespecified sensitivity analyses will assess robustness."
  ["project_brief_bg"]=>
  string(2159) "Canagliflozin has established cardiovascular and kidney benefits in people with type 2 diabetes. The CANVAS Program demonstrated reductions in major cardiovascular events and favorable kidney outcomes in patients with type 2 diabetes at high cardiovascular risk, while CREDENCE demonstrated substantial kidney and cardiovascular protection in patients with type 2 diabetes and albuminuric chronic kidney disease [1,2].

Most reports from these trials have used conventional time-to-first-event analyses and standard composite endpoints. These approaches are clinically useful but do not explicitly prioritize outcome components by clinical importance, and subsequent events after the first qualifying event may not contribute to the primary treatment comparison. Hierarchical composite endpoints analyzed with win statistics were developed to address this limitation by comparing treatment groups according to a prespecified clinical priority order [3]. Hierarchical approaches have subsequently been developed and evaluated for kidney disease progression and have been applied to randomized cardiorenal trial data [4,5].

We propose an individual participant data meta-analysis of CANVAS, CANVAS-R, and CREDENCE to estimate the prioritized overall cardiorenal effect of randomized canagliflozin versus placebo. The primary hierarchy will prioritize all-cause death, followed by major nonfatal cardiorenal events, and then sustained major loss of kidney function. The analysis will preserve randomized treatment assignment and will report not only the overall hierarchical treatment effect but also the contribution of each outcome tier.

This study is intended to complement, rather than replace, conventional hazard-ratio analyses. By integrating cardiovascular and kidney outcomes according to prespecified clinical priority, the project may provide a more patient-centered summary of canagliflozin's overall cardiorenal effect across complementary populations with type 2 diabetes. Sensitivity analyses using alternative clinically plausible hierarchies will assess whether conclusions depend materially on the chosen priority structure."
  ["project_specific_aims"]=>
  string(1022) "Aim 1: To quantify the prioritized overall cardiorenal effect of canagliflozin versus placebo using a prespecified hierarchical composite outcome in pooled individual participant data from CANVAS, CANVAS-R, and CREDENCE. We hypothesize that randomized canagliflozin will produce a more favorable prioritized cardiorenal outcome than placebo.

Aim 2: To determine which outcome tiers contribute to the overall hierarchical treatment effect and to compare the hierarchical findings with conventional component-specific and composite time-to-event analyses. We hypothesize that the overall result will not be explained solely by the lowest-priority kidney-function tier.

Aim 3: To assess robustness across prespecified alternative clinical hierarchies and key baseline kidney-risk strata, including eGFR and UACR categories where harmonizable. These analyses are supportive. We hypothesize that the direction of the treatment effect will remain broadly consistent across clinically plausible priority structures."
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      ["label"]=>
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      ["label"]=>
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      ["label"]=>
      string(51) "Meta-analysis using only data from the YODA Project"
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  ["project_research_methods"]=>
  string(1680) "Data source: Individual participant-level data from three YODA Project randomized, placebo-controlled canagliflozin trials: CANVAS (NCT01032629), CANVAS-R (NCT01989754), and CREDENCE (NCT02065791). No external participant-level data will be pooled in the primary analysis.

Study population: All randomized participants with a valid randomized treatment assignment will be eligible. Participants will be analyzed according to the intention-to-treat principle. Trial-specific eligibility criteria will not be re-applied, because the objective is to estimate the treatment effect across the randomized populations represented by the three trials. All canagliflozin dose/regimen groups will be combined as the active-treatment group and compared with placebo, with analyses stratified by trial.

Exclusions: No clinical exclusions based on post-randomization adherence, treatment discontinuation, changes in kidney function, albuminuria response, or occurrence of intermediate events are planned. Participants will only be omitted from a specific analysis when the outcome information required for that analysis cannot be derived from the shared dataset. Such omissions, if any, will be reported transparently.

Before analysis, protocols, statistical analysis plans, clinical study reports, data definitions, adjudicated endpoint files, laboratory files, and visit files will be reviewed to harmonize variable definitions across trials. Where an identical definition cannot be constructed, a common clinically interpretable definition will be prespecified before treatment-effect estimation, and trial-specific definitions will be examined in sensitivity analyses."
  ["project_main_outcome_measure"]=>
  string(1640) "Primary outcome: A prespecified hierarchical cardiorenal composite, evaluated in the following order: Tier 1, all-cause death; Tier 2, time to first major nonfatal cardiorenal event, defined as kidney failure, hospitalization for heart failure, nonfatal myocardial infarction, or nonfatal stroke; Tier 3, time to sustained >=40% decline in eGFR from baseline.

Kidney failure will be harmonized using adjudicated or derivable events reflecting chronic dialysis, kidney transplantation, or sustained severe kidney failure, according to information common across the trials. Sustained eGFR decline will be derived from serial kidney-function measurements using a harmonized confirmation rule where feasible. Exact operational definitions will be finalized from the trial protocols, SAPs, CSRs, endpoint definitions, and data dictionaries before treatment-effect analysis.

Secondary outcomes: individual components of the hierarchy; conventional cardiovascular and kidney time-to-first-event composites; all-cause and cardiovascular death; kidney failure; hospitalization for heart failure; nonfatal myocardial infarction; nonfatal stroke; and sustained eGFR decline.

Prespecified sensitivity outcomes will use alternative clinically plausible hierarchies, including kidney-prioritized and cardiovascular-prioritized structures; remove the eGFR-decline tier; use alternative sustained eGFR-decline thresholds where derivable; and restrict analyses to endpoints that can be harmonized identically across all three trials. Any deviation from these definitions after data access will be documented, justified, and reported."
  ["project_main_predictor_indep"]=>
  string(932) "The main independent variable is randomized treatment assignment: canagliflozin versus placebo. All randomized canagliflozin dose/regimen groups within CANVAS, CANVAS-R, and CREDENCE will be combined as the active-treatment group for the primary analysis. Treatment will be analyzed according to the intention-to-treat principle regardless of treatment discontinuation, adherence, dose changes, rescue therapy, changes in kidney function, or subsequent clinical events.

Trial identifier will be used as a stratification variable to preserve within-trial randomized comparisons and account for differences in trial populations, follow-up, and study design. No post-randomization response variable will be used to redefine treatment groups.

The primary estimand is the effect of assignment to canagliflozin versus placebo on the prioritized hierarchical cardiorenal outcome across the three randomized trial populations."
  ["project_other_variables_interest"]=>
  string(1427) "Baseline variables will be used to characterize the pooled study population and for prespecified supportive subgroup analyses. Variables of interest, where available and harmonizable, include age, sex, race/ethnicity, geographic region, smoking status, body mass index, systolic and diastolic blood pressure, HbA1c, serum creatinine, eGFR, urinary albumin-to-creatinine ratio (UACR), duration of diabetes, history of atherosclerotic cardiovascular disease, heart failure, myocardial infarction, stroke, and peripheral artery disease, and baseline use of renin-angiotensin-system blockers, diuretics, statins, antiplatelet therapy, insulin, and other glucose-lowering therapies.

Baseline eGFR and UACR will be the principal kidney-risk variables for supportive interaction analyses. Where data permit, eGFR will be categorized as <45, 45 to =60 mL/min/1.73 m2, and UACR as <30, 30 to =300 mg/g; continuous forms will also be retained for descriptive analyses. Trial-specific categories will be used in sensitivity analyses if anonymization or differing eligibility criteria prevent exact harmonization.

Because randomized treatment assignment is the primary exposure, baseline covariates will not be selected using stepwise or outcome-driven procedures. They will be used primarily for description, prespecified interaction analyses, and sensitivity analyses rather than to replace the randomized comparison."
  ["project_stat_analysis_plan"]=>
  string(4763) "Data preparation and harmonization: Protocols, statistical analysis plans, clinical study reports, data dictionaries, adjudicated endpoint datasets, laboratory datasets, and visit datasets will be reviewed before treatment-effect estimation. Units, coding, treatment assignments, endpoint definitions, and follow-up times will be harmonized across CANVAS, CANVAS-R, and CREDENCE. A dated analysis specification defining the hierarchy, censoring rules, and harmonized endpoint algorithms will be finalized before the primary treatment comparison.

Descriptive analysis: Baseline characteristics will be summarized by randomized treatment group within each trial and overall using means/SDs or medians/IQRs for continuous variables and counts/percentages for categorical variables. Standardized differences will be reported descriptively. No significance testing of baseline randomized-group differences will guide covariate selection.

Primary analysis: All randomized participants will be analyzed according to randomized assignment. A trial-stratified unmatched generalized pairwise-comparison/win-statistics analysis will compare canagliflozin with placebo. Treatment-control pairs will be formed within trial and assessed sequentially according to the prespecified hierarchy. A pair resolved at a higher-priority tier will not be evaluated at lower tiers. For time-to-event tiers, the participant with the more favorable event-free outcome within the comparison framework will be the winner; otherwise the pair will proceed to the next tier or be classified as tied/unresolved according to prespecified censoring rules. The principal effect measure will be the win ratio with a two-sided 95% confidence interval. Win odds, net benefit, win probability, proportions of wins/losses/ties, and the proportion of comparisons resolved at each tier will be reported to aid interpretation and identify which components drive the overall result.

Pooling across trials: Primary comparisons will preserve randomization by evaluating treatment-control contrasts within trial and combining trial-stratified information rather than making cross-trial participant comparisons. Heterogeneity will be explored by repeating the analysis separately in the CANVAS Program and CREDENCE and by presenting trial-specific estimates where estimable.

Conventional supportive analyses: Kaplan-Meier estimates and trial-stratified Cox proportional-hazards models will estimate treatment effects for all-cause death, kidney failure, hospitalization for heart failure, nonfatal myocardial infarction/stroke, sustained eGFR decline, and conventional cardiovascular and kidney composites. Hazard ratios with 95% confidence intervals will be reported. Proportional-hazards assumptions will be assessed using Schoenfeld residuals; if materially violated, restricted mean event-free time or another prespecified non-proportional-hazards summary will be used as supportive analysis.

Kidney-function derivation: Serial creatinine/eGFR measurements will be used to derive sustained eGFR-decline events using harmonized thresholds and confirmation windows where feasible. An optional secondary longitudinal analysis will summarize eGFR trajectories using mixed-effects models, but this will not replace the prespecified primary hierarchical analysis.

Sensitivity analyses: (1) kidney-prioritized and cardiovascular-prioritized alternative hierarchies; (2) removal of the eGFR-decline tier; (3) alternative sustained eGFR thresholds where derivable; (4) analyses restricted to identically harmonized/adjudicated outcomes; (5) each trial/program analyzed separately; (6) a common fixed follow-up horizon, if needed to address materially different follow-up distributions; and (7) supportive treatment-interaction analyses across prespecified baseline eGFR and UACR categories. Interaction analyses will be interpreted cautiously and will not be used to define post-randomization responder subgroups.

Missing data: Randomized treatment assignment will not be imputed. Missing baseline covariates will be described. Participants will not be excluded from the primary analysis solely because a nonessential baseline covariate is missing. For secondary longitudinal kidney models, likelihood-based mixed-effects methods will be used under a missing-at-random assumption, with additional sensitivity analyses if missingness is substantial.

Multiplicity and reporting: The hierarchical treatment comparison is the single primary hypothesis. Secondary outcome, sensitivity, and subgroup analyses will be considered supportive/exploratory. Two-sided 95% confidence intervals will be reported. No stepwise or outcome-driven variable selection will be used."
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  string(1096) "The project will begin immediately after data access is activated. Month 0-1: review protocols, SAPs, CSRs, data definitions, and shared datasets; create the harmonized analysis dataset and endpoint map. Month 2: complete data-quality checks and finalize a dated analysis specification before the primary treatment-effect analysis. Months 3-4: conduct the primary hierarchical analysis and conventional supportive analyses. Month 5: complete prespecified sensitivity and subgroup analyses and reproducibility checks of key results using independently rerun analysis code. Month 6: prepare tables, figures, and the first manuscript draft. Month 7: complete methodological quality-control review and finalize the manuscript. Month 8: submit the primary manuscript to a peer-reviewed journal. Months 9-11: address peer-review requests and conduct only justified supplementary analyses consistent with the approved proposal. By Month 12: report study status, results, presentations, and manuscript/publication information to the YODA Project and request an extension only if scientifically necessary."
  ["project_dissemination_plan"]=>
  string(1072) "We anticipate one primary peer-reviewed manuscript reporting the prioritized hierarchical cardiorenal analysis of CANVAS, CANVAS-R, and CREDENCE. The target audience includes cardiologists, nephrologists, diabetologists, clinical trialists, and outcomes researchers. Results will be reported regardless of whether the primary analysis is statistically significant or favorable to canagliflozin, and the manuscript will clearly identify the work as a post hoc individual participant data analysis of randomized trials.

Depending on the final clinical contribution and journal scope, potentially suitable journals include European Journal of Preventive Cardiology, Clinical Kidney Journal, Diabetes Care, Kidney International Reports, or Cardiovascular Diabetology. Results may also be submitted as an abstract to a cardiovascular, nephrology, or diabetes scientific meeting. No commercial or litigation-related dissemination is planned. The YODA Project and original trials will be acknowledged in accordance with the Data Use Agreement and publication requirements."
  ["project_bibliography"]=>
  string(1294) "

Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017;377(7):644-657. doi:10.1056/NEJMoa1611925.
Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019;380(24):2295-2306. doi:10.1056/NEJMoa1811744.
Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012;33(2):176-182. doi:10.1093/eurheartj/ehr352.
Redfors B, Gregson J, Crowley A, et al. The win ratio approach for composite endpoints: practical guidance based on previous experience. Eur Heart J. 2020;41(46):4391-4399. doi:10.1093/eurheartj/ehaa665.
Heerspink HJL, Jongs N, Schloemer P, et al. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023;34(12):2025-2038. doi:10.1681/ASN.0000000000000243.
Kondo T, Jhund PS, Gasparyan SB, et al. A hierarchical kidney outcome using win statistics in patients with heart failure from the DAPA-HF and DELIVER trials. Nat Med. 2024;30:1432-1439. doi:10.1038/s41591-024-02941-8.

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    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(19689)
    ["date"]=>
    string(19) "2026-08-06 16:54:58"
    ["modified"]=>
    string(19) "2026-08-06 16:54:58"
    ["menu_order"]=>
    int(0)
    ["mime_type"]=>
    string(15) "application/pdf"
    ["type"]=>
    string(11) "application"
    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_review_link"]=>
  bool(false)
  ["project_highlight_button"]=>
  string(0) ""
  ["request_data_partner"]=>
  string(0) ""
}
data partner
array(1) {
  [0]=>
  string(0) ""
}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(0) {
}


num of trials
array(1) {
  [0]=>
  string(1) "0"
}


res
array(1) {
  [0]=>
  string(1) "3"
}