{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:flow-trial",
  "owner": "cardio",
  "kind": "study",
  "slug": "flow-trial",
  "name": "FLOW: semaglutide and kidney outcomes in type 2 diabetes with chronic kidney disease",
  "aliases": [
    "FLOW"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial of people who have both type 2 diabetes and chronic kidney disease. Half took semaglutide 1.0 mg once a week and half took placebo. The semaglutide group had a lower risk of kidney failure, a large fall in kidney function, or death from a kidney or heart cause. The trial was stopped early at a planned interim check.",
  "summary_technical": "Randomized, placebo-controlled trial sponsored by Novo Nordisk (NCT03819153). 3533 participants were randomized (1767 semaglutide, 1766 placebo), median follow-up 3.4 years. Primary outcome (kidney failure, at least a 50% reduction in eGFR, or death from kidney-related or cardiovascular causes): 331 against 410 first events, hazard ratio 0.76 (95% CI 0.66 to 0.88; P=0.0003). Early cessation was recommended at a prespecified interim analysis.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": null,
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT03819153",
      "normalized_value": "NCT03819153",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "kidneys",
        "metabolism"
      ],
      "condition-area": [
        "kidney-connections",
        "diabetes-and-metabolic-disease"
      ]
    }
  },
  "payload": {
    "design": "Randomized, placebo-controlled trial with parallel groups. The registry records phase 3 and quadruple masking.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2019-06-17",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2024-01-09",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
    },
    "completion_date": {
      "date": "2024-01-09",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
    },
    "results_first_posted": {
      "date": "2025-03-20",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "AR",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "AU",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "BE",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "BR",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "BG",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "CN",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "FR",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "GR",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "HU",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "IN",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "IL",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "JP",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "MY",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "MX",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "NL",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "PL",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "RU",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "SK",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "ZA",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "ES",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "TH",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "UA",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      },
      {
        "code": "TR",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": {
      "scope": "trial",
      "date": null,
      "reason": "Early cessation of the trial was recommended at a prespecified interim analysis. The sentence read does not give the reason. The registry records the study as completed.",
      "snapshot": "cardio:pubmed-38785209-2026-10-14"
    },
    "enrollment": [
      {
        "count": 3533,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct03819153-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:flow-arm-semaglutide",
        "label": "Semaglutide",
        "intervention": "cardio:semaglutide",
        "description": "Subcutaneous semaglutide 1.0 mg once weekly, added to standard care."
      },
      {
        "id": "cardio:flow-arm-placebo",
        "label": "Placebo",
        "intervention": null,
        "description": "Placebo, added to standard care."
      }
    ],
    "findings": []
  },
  "content_digest": "7b577cfb4dd45eef367f324a784d6ce71953b316efb9a288fc270398894cb917",
  "review": {
    "content_digest": "7b577cfb4dd45eef367f324a784d6ce71953b316efb9a288fc270398894cb917",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests semaglutide",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:semaglutide",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03819153-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Lists type 2 diabetes as its condition",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:type-2-diabetes",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03819153-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Enrolled people who have both type 2 diabetes and chronic kidney disease",
        "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:pubmed-38785209-2026-10-14",
          "locator": "Abstract, METHODS, sentence 1, fragment 1 of 4"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:novo-nordisk",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03819153-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name"
        },
        "primary": false,
        "role": "lead",
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Names a persistent eGFR reduction 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-nct03819153-2026-10-14",
          "locator": "protocolSection.outcomesModule.primaryOutcomes[0].measure"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/flow-trial/",
  "context_path": "api/v1/context/cardio--flow-trial.md"
}