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Status: Ongoing First registered on: 11/02/2020

Last updated on: 02/06/2020

1. Study identification

EU PAS Register NumberEUPAS33537

Official titleAdverse ReNal OuTcomEs in patients with NoN-Valvular Atrial fibrillation treated with Rivaroxaban or Vitamin K Antagonists

Study title acronymANTENNA

Study typeObservational study

Brief description of the studyBy evaluating routine clinical practice data from the UK primary care database, researchers in this study want to gather information on the kidney function of patients with non-valvular atrial fibrillation (NVAF, irregularly heart beats which is not caused by a heart valve problem) who are treated with Rivaroxaban (non-vitamin K antagonist, brand name Xarelto) or vitamin K antagonists (VKAs). The study planned to enroll about 25,000 male or female patients who were at least 18 years old and were new users of Rivaroxaban or VKAs between 01 January 2014 and 30 September 2019. Researchers are especially interested in whether patients experienced under treatment any worsening in kidney function, the onset of acute kidney diseases or injuries. In addition, risk of worsening in kidney function in patients with or without diabetes or heart failures are of interest to the researchers

Was this study requested by a regulator?No

Is the study required by a Risk Management Plan (RMP)? Not applicable

Regulatory procedure number (RMP Category 1 and 2 studies only)

Other study registration identification numbers and URLs as applicable

2. Research centres and Investigator details

Coordinating study entity

Centre to which the investigator belongsCEIFE

Department/Research groupSpanish Centre for Pharmacoepidemiologic Research

Organisation/affiliationFundación CEIFE

Website/Homepagewww.ceife.es

Details of (Primary) lead investigator

Title Dr

Last name BAYER AG

First name Bayer Clinical Trials

Is this study being carried out with the collaboration of a research network?

Other centres where this study is being conducted

Not applicable (single centre)

Countries in which this study is being conducted

National study

United Kingdom

3. Study timelines: initial administrative steps, progress reports and final report

PlannedActual

Date when funding contract was signed02/02/202002/02/2020

Start date of data collection01/05/202001/05/2020

Start date of data analysis

Date of interim report, if expected

Date of final study report01/04/2021

4. Sources of funding

Please provide estimates of the percentage of funding by source for this study

Names(s)Approximate % funding

Pharmaceutical companiesBayer AG100

Charities

Government body

Research councils

EU funding scheme

5. Contact details for enquiries

Scientific Enquiries

Title Dr

Last name BAYER AG

First name Bayer Clinical Trials

Address line 1Muellerstrasse 178

Address line 2

Address line 3

CityBerlin

Postcode13342

CountryGermany

Phone number (incl. country code)49-30300139005

Alternative phone number

Fax number (incl. country code)

Email address clinical-trial-disclosure@bayer.com

Public Enquiries

Title Dr

Last name BAYER AG

First name Bayer Clinical Trials

Address line 1Muellerstrasse 178

Address line 2

Address line 3

CityBerlin

Postcode13342

CountryGermany

Phone number (incl. country code)49-30300139005

Alternative phone number

Fax number (incl. country code)

Email address clinical-trial-disclosure@bayer.com

11. Scope of the study

What is the scope of the study?

evaluation of posisble difference in renal function decline under rivaroxaban and warfarin chronic treatment

Primary scope : evaluation of posisble difference in renal function decline under rivaroxaban and warfarin chronic treatment

12. Main objective(s)

What is the main objective of the study?

To estimate the magnitude of renal decline, incidence of end-stage renal disease (ESRD) and acute kidney injury (AKI) in patients with NVAF treated with rivaroxaban and those treated with a VKA according to the presence of CKD and its severity at the start of OAC therapy in UK primary care

Are there primary outcomes?Yes

- %change in serum creatinine - doubling of serum creatinine - rate of eGFR change - %eGFR change - incidence of ESRD and AKI

Are there secondary outcomes?No

13. Study design

What is the design of the study?

Cohort study

14. Follow-up of patients

Will patients be followed up?Yes

Please describe duration of follow up

Patients will be followed up from their start date until the occurrence of an adverse renal outcome. Independent follow-ups will be undertaken for each renal decline outcome, and for the outcome of AKI starting from the start date

15. Data analysis plan

Please provide a brief summary of the analysis method

Cohort analyses: The difference in the eGFR slopes after initiation between patients starting on rivaroxaban and on a VKA will be assessed using a linear mixed regression model. Only individuals with at least two recorded eGFR measurements after treatment initiation will be included in this analysis. Incidence rates of each adverse renal outcome will be calculated with 95% CIs assuming a Poisson distribution. Incidence rates will be stratified by age-group, sex, CKD stage at baseline, the starting OAC, and for rivaroxaban, the dose of the starting prescription (20 mg/day or 15 mg/day). A survival analysis using Cox proportional hazard regression, will be performed to compare the time to the occurrence of the study outcomes according to the starting OAC. Case–control analyses: Unconditional logistic regression will be used to ORs with 95% CIs to estimate the associations between current exposure to rivaroxaban/VKA and and the study outcomes adjusted for confounders