Replication of the DAPA-CKD (Chronic Kidney Disease) Trial in Healthcare Claims Data

NCT04882813 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-DAPA-CKD
• Study Type: observational
• Target: 87,727
• Locations: 1 country
• Sites: 1

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 clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Relative hazard of the composite of end-stage renal disease or all-cause mortality

  Claims-based algorithm: see attached protocol for full definition

  To study completion or censoring, up to 32 months

Secondary Outcomes (2)

• Relative hazard of end-stage renal disease

  To study completion or censoring event, up to 32 months

• Relative hazard of all-cause mortality

  To study completion or censoring event, up to 32 months

Study Arms (2)

Dapagliflozin

Exposure group

Drug: Dapagliflozin

Sitagliptin

Reference group

Drug: Sitagliptin

Interventions

Dapagliflozin DRUG

Dapagliflozin dispensing claim is used as the exposure group.

Dapagliflozin

Sitagliptin DRUG

Sitagliptin dispensing claim is used as the reference group.

Sitagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will involve a new user, parallel group, retrospective cohort study design comparing dapagliflozin to sitagliptin. Although the trial compared dapagliflozin to placebo, for the current emulation we used an active comparator, sitagliptin, which is a dipeptidyl peptidase - (DPP-4) inhibitor. This is because both dapagliflozin and sitagliptin are guideline recommended as second to third line therapies used for the treatment of type 2 diabetes at the same stage of the disease and sitagliptin is not expected to have an effect on the primary outcome.

You may qualify if:

• 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\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 12, 2021
• Study Start: December 13, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

US (1)