Trial Outcomes & Findings for Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access (NCT NCT02475837)

NCT ID: NCT02475837

Last Updated: 2019-01-14

Results Overview

Time to AV fistula functional maturation (defined as successful cannulation of the AV fistula for six hemodialysis sessions within three weeks).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: up to 238 days
• Results posted on: 2019-01-14

Participant Flow

17 participants were enrolled, 13 were randomized.

Participant milestones

Measure	Vorapaxar Intervention Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.5 mg orally once daily).	Placebo Intervention Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.
Overall Study STARTED	6	7
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access

Baseline characteristics by cohort

Measure	Vorapaxar Intervention n=6 Participants Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.5 mg orally once daily).	Placebo Intervention n=7 Participants Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.	Total n=13 Participants Total of all reporting groups
Age, Continuous	50.0 years n=5 Participants	62.0 years n=7 Participants	56.0 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 238 days

Population: Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.

Time to AV fistula functional maturation (defined as successful cannulation of the AV fistula for six hemodialysis sessions within three weeks).

Outcome measures

Measure	Vorapaxar Intervention n=6 Participants Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.08 mg orally once daily).	Placebo Intervention n=7 Participants Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.
Time to AV Fistula Functional Maturation	169 Days to functional maturation Interval 96.0 to 238.0	145 Days to functional maturation Interval 76.0 to 197.0

SECONDARY outcome

Timeframe: up to 238 days

Population: Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.

Participants able to use their AV fistula for dialysis within 180 days of surgery were considered to have met the outcome.

Outcome measures

Measure	Vorapaxar Intervention n=6 Participants Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.08 mg orally once daily).	Placebo Intervention n=7 Participants Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.
Count of Participants With AV Fistula Use	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 150-238 days

Population: Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.

Criteria for outcome: AV fistula patency at 150-180 days, with at least 50% increase in vein diameter by ultrasound compared with preoperative vein diameter measurement.

Outcome measures

Measure	Vorapaxar Intervention n=6 Participants Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.08 mg orally once daily).	Placebo Intervention n=7 Participants Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.
Count Participants With AV Fistula Patency	1 Participants	5 Participants

SECONDARY outcome

Timeframe: up to 238 days

Population: Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.

Bleeding events according to GUSTO (criteria for bleeding: Severe, Moderate or Mild) and BARC (bleeding criteria Type 0-5, with 0 being no bleeding and 5 referring to probable or definite fatal bleeding) Criteria

Outcome measures

Measure	Vorapaxar Intervention n=6 Participants Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.08 mg orally once daily).	Placebo Intervention n=7 Participants Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.
Count of All Participants With Bleeding Events	0 Participants	1 Participants

Adverse Events

Vorapaxar Intervention

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Intervention

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vorapaxar Intervention n=6 participants at risk Participants were randomized to receive vorapaxar sulfate for 12 weeks (2.08 mg orally once daily).	Placebo Intervention n=7 participants at risk Participants were randomized to receive placebo to match vorapaxar sulfate for 12 weeks.
Blood and lymphatic system disorders Aplastic crisis in setting of sickle cell anemia	0.00% 0/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	14.3% 1/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Cardiac disorders Superior vena cava syndrome	16.7% 1/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	0.00% 0/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Gastrointestinal disorders Melena due to duodenal ulceration	0.00% 0/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	14.3% 1/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Renal and urinary disorders Dilation of left ureteral-ileal stricture	16.7% 1/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	0.00% 0/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Renal and urinary disorders Shortness of breath due to volume overload	0.00% 0/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	14.3% 1/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Renal and urinary disorders Renal transplant	16.7% 1/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	0.00% 0/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Renal and urinary disorders Clogged nephrostomy tube	16.7% 1/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	0.00% 0/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Infections and infestations Miliary tuberculosis	0.00% 0/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	14.3% 1/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Infections and infestations Community acquired pneumonia	0.00% 0/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	14.3% 1/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Infections and infestations Severe fever to due catheter infection	0.00% 0/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	14.3% 1/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Infections and infestations Abdominal abscess	16.7% 1/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	0.00% 0/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.
Cardiac disorders Tachycardia	0.00% 0/6 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.	14.3% 1/7 • Up to 238 days Pre-specified time for assessment of Adverse Events was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.

Other adverse events

Adverse event data not reported

Additional Information

Ken Mahaffey MD

Stanford University

Phone: 650.723.3096

Email: kmahaf@stanford.edu

Results disclosure agreements

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

Restriction type: OTHER