DKDComposite-Adj (디케이디컴포지트엣지)

⚠️ 본 도구는 연구용 · DSMB 보조용 prototype이며, 실제 trial endpoint 판정은 sponsor/CEC의 공식 SOP 및 통계분석계획서(SAP)를 따라야 합니다.

① Multi-source ingest + 표준 schema 변환

eCRF CSV (REDCap/Medidata 호환) 업로드 또는 동봉된 demo 데이터 로드.

CSV 업로드

필수 컬럼: subject_id, visit_id, visit_date, sCr_mgdL, UACR_mgg, age, sex, dialysis_modality, dialysis_access_date, transplant_date, renal_death_date, CV_death_date, conmed_ATC

Subjects

—

Visit rows

—

Date range

—

Female %

—

표준 schema preview (첫 50행)

② eGFR sustained decline + UACR doubling 자동 판정

CKD-EPI 2021 race-free formula · 환자별 baseline 대비 sustained confirmation

eGFR decline threshold

Sustained confirmation

Confirmation visits

③ 5점 composite endpoint 자동 도달

(i) eGFR sustained decline (ii) UACR doubling (iii) ESKD (dialysis≥90d · transplant · eGFR<15 sustained) (iv) renal death (v) CV death · first event 우선

Composite events

—

Censored

—

Event rate

—

환자별 first event

Kaplan–Meier (composite)

④ 2-reader paired blinded adjudication

각 case의 patient ID는 마스킹되며 reader 1/2 입력 칸은 매 case마다 무작위로 좌·우 위치가 바뀝니다.

Cases queued

—

Both adjudicated

—

Disagreement → 3rd

—

Cohen's κ

—

⑤ DSMB Dashboard + 한국어 보고서

SGLT2i ever-use only Finerenone ever-use only GLP-1RA ever-use only

N enrolled

—

Composite events

—

eGFR decline

—

UACR doubling

—

ESKD

—

Renal death

—

CV death

—

Primary composite KM (filter-aware)

동반약물 sensitivity covariate

사이트 단위 한국어 요약 (인쇄용)

CDISC ADaM (ADRENAL / ADKID) schema preview

실제 sponsor SDTM→ADaM 매핑은 통계분석계획서를 따르세요. 본 preview는 변수 alignment 검토용입니다.

ADKID (Kidney composite endpoint)

USUBJID    char  Unique Subject Identifier
AGE        num   Age at Baseline (years)
SEX        char  M/F
TRTSDT     date  Treatment Start Date
ADT        date  Analysis Date (event/censor)
AVAL       num   Time to event (days)
CNSR       num   0=event, 1=censor
PARAMCD    char  COMPOS / EGFRD40 / UACRDB / ESKD / RDTH / CVDTH
PARAM      char  Parameter (text)
EGFR       num   CKD-EPI 2021 race-free eGFR (mL/min/1.73m²)
EGFRBL     num   Baseline eGFR
EGFRPCHG   num   % change from baseline
UACR       num   UACR (mg/g)
UACRBL     num   Baseline UACR
DIALYSIS   char  N/HD/PD
TRANSPLNT  char  Y/N
SGLT2IFL   char  SGLT2i ever-use flag (Y/N)
FINEREFL   char  Finerenone ever-use flag (Y/N)
GLP1FL     char  GLP-1RA ever-use flag (Y/N)
ADJRSLT1   char  Reader1 adjudication (Confirm/Reject)
ADJRSLT2   char  Reader2 adjudication (Confirm/Reject)
ADJRSLT3   char  Reader3 (only if disagree)
ADJFNL     char  Final adjudication

ADRENAL (Renal lab longitudinal)

USUBJID    char  Unique Subject Identifier
VISIT      char  Visit name
VISITNUM   num   Visit number
ADT        date  Analysis Date
PARAMCD    char  SCR / UACR / EGFR
PARAM      char  Parameter
AVAL       num   Value
AVALC      char  Character value
BASE       num   Baseline value
CHG        num   Change from baseline
PCHG       num   % change from baseline
ANL01FL    char  Analysis flag