Trial Outcomes & Findings for Can Rivaroxaban Lead to Anticoagulation-Related Nephropathy? (NCT NCT02900170)

NCT ID: NCT02900170

Last Updated: 2020-07-07

Results Overview

Primary endpoint - Incidence of ARN is the primary outcome of this study and this is based on a documentation of AKI (defined as an increase in baseline serum creatinine ≥ 0.3 mg/dL), in the absence of any other obvious etiology for the AKI identified after a standard clinical evaluation and work up by the patient's primary care physician, cardiologist or nephrologist. This incidence will be expressed as a percentage.

• Recruitment status: COMPLETED
• Target enrollment: 8 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-07-07

Participant Flow

Participant milestones

Measure	Participants 8 patients were enrolled in the study. Baseline creatinine and urinalysis was obtained.
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Participants 8 patients were enrolled in the study. Baseline creatinine and urinalysis was obtained.
Overall Study Lost to Follow-up	8

Baseline Characteristics

Can Rivaroxaban Lead to Anticoagulation-Related Nephropathy?

Baseline characteristics by cohort

Measure	Participants n=8 Participants 8 patients were enrolled in the study. Baseline creatinine and urinalysis was obtained.
Age, Continuous	70.6 years STANDARD_DEVIATION 7.82 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Primary endpoint - Incidence of ARN is the primary outcome of this study and this is based on a documentation of AKI (defined as an increase in baseline serum creatinine ≥ 0.3 mg/dL), in the absence of any other obvious etiology for the AKI identified after a standard clinical evaluation and work up by the patient's primary care physician, cardiologist or nephrologist. This incidence will be expressed as a percentage.

Outcome measures

Measure	Participants n=8 Participants 8 patients were enrolled in the study. Baseline creatinine and urinalysis was obtained.
Incidence of Anticoagulant-related Nephropathy in the Cohort	0 Percentage of participants

Adverse Events

Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Basma Abdulhadi

Albert Einstein Medical Center

Phone: 215456500

Email: abdulhab@einstein.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place