- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04882813
Replication of the DAPA-CKD (Chronic Kidney Disease) Trial in Healthcare Claims Data
July 25, 2023 updated by: Shirley Vichy Wang, Brigham and Women's Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above.
Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial.
Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice.
Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Study Type
Observational
Enrollment (Actual)
87727
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
-
Boston, Massachusetts, United States, 02120
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sitagliptin
Reference group
|
Sitagliptin dispensing claim is used as the reference group.
|
Dapagliflozin
Exposure group
|
Dapagliflozin dispensing claim is used as the exposure group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative hazard of the composite of end-stage renal disease or all-cause mortality
Time Frame: To study completion or censoring, up to 32 months
|
Claims-based algorithm: see attached protocol for full definition
|
To study completion or censoring, up to 32 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative hazard of end-stage renal disease
Time Frame: To study completion or censoring event, up to 32 months
|
Claims-based algorithm: see attached protocol for full definition
|
To study completion or censoring event, up to 32 months
|
Relative hazard of all-cause mortality
Time Frame: To study completion or censoring event, up to 32 months
|
Claims-based algorithm: see attached protocol for full definition
|
To study completion or censoring event, up to 32 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2020
Primary Completion (Actual)
June 11, 2021
Study Completion (Actual)
June 11, 2021
Study Registration Dates
First Submitted
May 4, 2021
First Submitted That Met QC Criteria
May 6, 2021
First Posted (Actual)
May 12, 2021
Study Record Updates
Last Update Posted (Actual)
July 28, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Sodium-Glucose Transporter 2 Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Dapagliflozin
- Sitagliptin Phosphate
Other Study ID Numbers
- 2018P002966-DUP-DAPA-CKD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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