{
  "release_id": "5dcd9b263fe17744",
  "id": "cardio:empa-kidney",
  "owner": "cardio",
  "kind": "study",
  "slug": "empa-kidney",
  "name": "EMPA-KIDNEY: empagliflozin in a broad range of chronic kidney disease",
  "aliases": [
    "EMPA-KIDNEY"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial of people with chronic kidney disease who were at risk of it getting worse, with or without diabetes. Half took empagliflozin 10 mg a day and half took placebo. Empagliflozin lowered the risk of kidney disease getting worse or death from a heart cause. Fewer people were admitted to hospital for any reason. Deaths from any cause did not differ significantly. The trial was stopped early at a planned interim analysis.",
  "summary_technical": "Randomized, double-blind, placebo-controlled trial sponsored by Boehringer Ingelheim, with the University of Oxford and Eli Lilly as registry collaborators (NCT03594110). 6609 patients were randomized; median follow-up 2.0 years. Primary outcome (progression of kidney disease or death from cardiovascular causes): 432 of 3304 (13.1%) against 558 of 3305 (16.9%), hazard ratio 0.72 (95% CI 0.64 to 0.82; P<0.001). The trial was stopped early for efficacy at a formal interim analysis (PMC full text).",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": null,
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT03594110",
      "normalized_value": "NCT03594110",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "kidneys"
      ],
      "condition-area": [
        "kidney-connections"
      ]
    }
  },
  "payload": {
    "design": "Randomized, parallel-group, double-blind, placebo-controlled, multicenter international trial (registry official title). The registry records phase 3 and double masking.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2019-01-31",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2022-07-05",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
    },
    "completion_date": {
      "date": "2024-07-02",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
    },
    "results_first_posted": {
      "date": "2023-07-27",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
      },
      {
        "code": "CN",
        "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
      },
      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
      },
      {
        "code": "JP",
        "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
      },
      {
        "code": "MY",
        "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": {
      "scope": "trial",
      "date": null,
      "reason": "The data and safety monitoring board reported at a formal interim analysis that both conditions for stopping early for efficacy were met. The registry records the study as completed.",
      "snapshot": "cardio:pmc-pmc7614055-2026-10-14"
    },
    "enrollment": [
      {
        "count": 6609,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct03594110-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:empa-kidney-arm-empagliflozin",
        "label": "Empagliflozin 10 mg",
        "intervention": null,
        "description": "Empagliflozin 10 mg once daily."
      },
      {
        "id": "cardio:empa-kidney-arm-placebo",
        "label": "Placebo",
        "intervention": null,
        "description": "Matching placebo."
      }
    ],
    "findings": []
  },
  "content_digest": "418efed405be3e5be26b65d7c01b893e42f536b4b3db9bc168a1c632b90a3594",
  "review": {
    "content_digest": "418efed405be3e5be26b65d7c01b893e42f536b4b3db9bc168a1c632b90a3594",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Lists chronic kidney disease as its condition",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:chronic-kidney-disease",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03594110-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:boehringer-ingelheim",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03594110-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name"
        },
        "primary": false,
        "role": "lead",
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "sponsored_by",
        "label": "Collaborator on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:eli-lilly",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03594110-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.collaborators[1].name"
        },
        "primary": false,
        "role": "collaborator",
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Tests this medicine",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:empagliflozin",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03594110-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Defines kidney disease progression by an eGFR fall in its primary outcome",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:egfr",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03594110-2026-10-14",
          "locator": "protocolSection.outcomesModule.primaryOutcomes[0].description"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/empa-kidney/",
  "context_path": "api/v1/context/cardio--empa-kidney.md"
}