Trial Outcomes & Findings for Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients (NCT NCT04046263)

NCT ID: NCT04046263

Last Updated: 2022-08-31

Results Overview

Serum phosphate at baseline

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2022-08-31

Participant Flow

Participant milestones

Measure	Sucroferric Oxyhydroxide Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. Sucroferric Oxyhydroxide Chewable Tablet: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Overall Study STARTED	17
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients

Baseline characteristics by cohort

Measure	Intervention n=17 Participants Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. Sucroferric Oxyhydroxide Chewable Tablet: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Age, Continuous	55 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Serum phosphate at baseline

Outcome measures

Measure	Intervention n=17 Participants Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. Sucroferric Oxyhydroxide Chewable Tablet: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Serum Phosphate at Baseline	7.47 mg/dL Standard Deviation 1.76

PRIMARY outcome

Timeframe: 6 months

Population: Outcome measure data could not be collected for all participants at the 6 month timepoint due to some participants discontinuing the study.

Serum phosphate at end of study (6 months)

Outcome measures

Measure	Intervention n=12 Participants Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. Sucroferric Oxyhydroxide Chewable Tablet: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Serum Phosphate at 6 Months	5.69 mg/dL Standard Deviation 1.17

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Outcome measure data could not be collected for all participants at the 6 month timepoint due to some participants discontinuing the study.

Changes in serum albumin from baseline to 6 months

Outcome measures

Measure	Intervention n=17 Participants Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. Sucroferric Oxyhydroxide Chewable Tablet: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Serum Albumin Baseline	3.49 g/dL Standard Deviation 0.37
Serum Albumin 6 Months	3.50 g/dL Standard Deviation 0.27

SECONDARY outcome

Timeframe: 6 months

Population: This outcome measure could not be collected due to unforeseen changes in the study capability caused by the COVID-19 public health crisis.

Change in serum FGF23 from baseline to 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Outcome measure data could not be collected for all participants at the 6 month timepoint due to some participants discontinuing the study.

Change in serum PTH (perathyroid hormone) from baseline to 6 months

Outcome measures

Measure	Intervention n=17 Participants Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. Sucroferric Oxyhydroxide Chewable Tablet: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Serum PTH Baseline	416 picograms/mL Interval 292.0 to 631.0
Serum PTH 6 Months	361 picograms/mL Interval 237.0 to 540.0

SECONDARY outcome

Timeframe: 6 months

Population: This outcome measure could not be collected due to unforeseen changes in the study capability caused by the COVID-19 public health crisis.

Change in prealbumin from baseline to 6 months

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 2 serious events

Other events: 9 other events

Deaths: 2 deaths

Serious adverse events

Measure

Intervention n=17 participants at risk Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. Sucroferric Oxyhydroxide Chewable Tablet: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal

Cardiac disorders Death

11.8% 2/17 • Number of events 2 • Up to 6 months

Other adverse events

Measure

Intervention n=17 participants at risk Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. Sucroferric Oxyhydroxide Chewable Tablet: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal

Gastrointestinal disorders GI symptoms

52.9% 9/17 • Number of events 9 • Up to 6 months

Additional Information

Jessica Kendrick, MD

University of Colorado Denver | Anschutz

Phone: 303-724-1111

Email: clinicalresearchsupportcenter@ucdenver.edu

Results disclosure agreements

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