{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:fidelio-dkd",
  "owner": "cardio",
  "kind": "study",
  "slug": "fidelio-dkd",
  "name": "FIDELIO-DKD: finerenone and kidney outcomes in type 2 diabetes",
  "aliases": [
    "FIDELIO-DKD"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial of people with chronic kidney disease and type 2 diabetes. Half took finerenone and half took placebo, on top of the usual blood-pressure medicines that act on the renin-angiotensin system. Finerenone lowered the risk of kidney failure, a large fall in kidney function, or death from a kidney cause, and lowered the risk of a combined heart outcome. High potassium led to stopping the trial medicine more often on finerenone.",
  "summary_technical": "Randomized, double-blind trial sponsored by Bayer (NCT02540993). 5734 patients with chronic kidney disease and type 2 diabetes were randomized 1:1; median follow-up 2.6 years. Primary outcome (kidney failure, a sustained decrease of at least 40% in eGFR, or death from renal causes): 504 of 2833 (17.8%) against 600 of 2841 (21.1%), hazard ratio 0.82 (95% CI 0.73 to 0.93; P=0.001). Key secondary cardiovascular outcome: hazard ratio 0.86 (95% CI 0.75 to 0.99).",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": null,
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT02540993",
      "normalized_value": "NCT02540993",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "kidneys"
      ],
      "condition-area": [
        "kidney-connections",
        "diabetes-and-metabolic-disease"
      ]
    }
  },
  "payload": {
    "design": "Randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven trial (registry official title). The registry records phase 3 and quadruple masking.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2015-09-17",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2020-04-14",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
    },
    "completion_date": {
      "date": "2020-04-14",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
    },
    "results_first_posted": {
      "date": "2021-07-19",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "AR",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "AU",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "AT",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "BE",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "BR",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "BG",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "CL",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "CN",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "CO",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "CZ",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "DK",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "FI",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "FR",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "GR",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "HU",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "IE",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "IL",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "JP",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "LT",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "MY",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "MX",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "NL",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "NZ",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "NO",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "PH",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "PL",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "PT",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
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      {
        "code": "PR",
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      },
      {
        "code": "RO",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "RU",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "SG",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "SK",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "ZA",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "KR",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "ES",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "SE",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "CH",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "TW",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "TH",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "UA",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "VN",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "TR",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      },
      {
        "code": "HK",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 5734,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct02540993-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:fidelio-dkd-arm-finerenone",
        "label": "Finerenone",
        "intervention": "cardio:finerenone",
        "description": "Finerenone (registry code BAY94-8862) in addition to standard of care, including renin-angiotensin system blockade."
      },
      {
        "id": "cardio:fidelio-dkd-arm-placebo",
        "label": "Placebo",
        "intervention": null,
        "description": "Placebo in addition to standard of care."
      }
    ],
    "findings": []
  },
  "content_digest": "e7e66da13281bf9b17f9f1705d202f739a684829512bb9b53734b38439623d77",
  "review": {
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    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests finerenone",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:finerenone",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
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          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
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        "primary": false,
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      {
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        "label": "Lists chronic kidney disease as its condition",
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        "family": "sourced",
        "other_entity_id": "cardio:chronic-kidney-disease",
        "other_entity_in_atlas": true,
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      {
        "predicate": "investigates",
        "label": "Enrolled people with chronic kidney disease and type 2 diabetes",
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        "family": "sourced",
        "other_entity_id": "cardio:type-2-diabetes",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:pubmed-33264825-2026-10-14",
          "locator": "Abstract, METHODS, sentence 1"
        },
        "primary": false,
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      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor",
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        "family": "sourced",
        "other_entity_id": "cardio:bayer",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
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        "primary": false,
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      {
        "predicate": "investigates",
        "label": "Names a sustained eGFR decrease in its primary outcome",
        "clinical_claim_not_fact": false,
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        "other_entity_id": "cardio:egfr",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
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          "locator": "protocolSection.outcomesModule.primaryOutcomes[0].measure"
        },
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    ],
    "incoming": []
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  "page_path": "studies/fidelio-dkd/",
  "context_path": "api/v1/context/cardio--fidelio-dkd.md"
}