Status:
COMPLETED
Replication of the DAPA-CKD (Chronic Kidney Disease) Trial in Healthcare Claims Data
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Brief Summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of cl...
Detailed Description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to re...
Eligibility Criteria
Inclusion
- Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
- 18 years of age \[Day 0, Day 0\]
- eGFR ≥25 and ≤75 mL/min/1.73 m2 (CKD-EPI formula) at visit 1 (- All Time, Day 0\]
- Evidence of increased albuminuria for 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1(- All Time, Day 0\]
- Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACEi or ARB for at least 4 weeks before visit 1, if not medically contraindicated (-All Time, Day -45\]
Exclusion
- Type I diabetes mellitus (-All Time, Day 0\]
- Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or Antineutrophil cytoplasmic antibody (ANCA) - associated vasculitis (-All Time, Day 0\]
- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrollment \[Day -180, Day 0\]
- NYHA class IV congestive heart failure at the time of enrollment \[Day -180, Day 0\]
- MI, unstable angina, stroke, transient ischemic attack within 8 weeks prior to enrollment \[ Day -56, Day 0\]
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 8 weeks prior to enrollment \[Day -56, Day 0\]
- Any condition outside the renal and cardiovascular study area with a life expectancy of \<2 years based on investigator's clinical judgement \[Day 0, Day 0\]
- Hepatic impairment \[aspartate transaminase or alanine transaminase \>3 times the upper limit of normal (ULN) or total bilirubin \>2 times the ULN at the time of enrollment\] (- All Time, Day 0\]
- History of organ transplantation (- All Time, Day 0\]
- Receiving therapy with SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor \[Day -56, Day -1\]
- Exclude patients that have AKI, CKD V, ESRD and are on HD/PD during the baseline period \[Day -14, Day 0\] for AKI and \[Day -180, Day 0\] for CKD, ESRD, or Hemodialysis/Peritoneal Dialysis
Key Trial Info
Start Date :
December 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
87727 Patients enrolled
Trial Details
Trial ID
NCT04882813
Start Date
December 13 2020
End Date
June 11 2021
Last Update
July 28 2023
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120