Trial Outcomes & Findings for Treatment Modification to Reduce Symptom Burden in Hemodialysis (NCT NCT01775800)

NCT ID: NCT01775800

Last Updated: 2018-10-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: Each participant was assessed for 6 weeks; total recruitment period was 15 months
• Results posted on: 2018-10-09

Participant Flow

There were 300 dialysis patients screened. 51 were eligible to participate and 16 were randomized.

Participant milestones

Measure	Treatment Modification Patients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus. Treatment modification	Usual Care Patients will receive the usual hemodialysis care with no modifications
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment Modification to Reduce Symptom Burden in Hemodialysis

Baseline characteristics by cohort

Measure	Treatment Modification n=8 Participants Patients were treated to modified goals in terms of blood pressure, parathyroid hormone and phosphorus	Usual Care n=8 Participants Patients were treated to traditional goals in terms of blood pressure, parathyroid hormone and phosphorus	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Continuous	72.38 years STANDARD_DEVIATION 10.29 • n=5 Participants	69.50 years STANDARD_DEVIATION 16.59 • n=7 Participants	70.94 years STANDARD_DEVIATION 13.42 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	4 Participants n=7 Participants	10 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Each participant was assessed for 6 weeks; total recruitment period was 15 months

Population: This number represents the entire dialysis population

Outcome measures

Measure	Dialysis Patients n=300 Participants Patients were recruited from two dialysis units, one located in Manhattan and on in Queens, New York, representing the total dialysis population	Usual Care Patients were treated to traditional goals in terms of blood pressure, parathyroid hormone and phosphorus
Number of Participants Recruited, Consented, Randomized and Completed Transplant ineligible	51 Participants	—
Number of Participants Recruited, Consented, Randomized and Completed Consented	16 Participants	—
Number of Participants Recruited, Consented, Randomized and Completed Data collected	16 Participants	—
Number of Participants Recruited, Consented, Randomized and Completed Completed	16 Participants	—

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Number of symptoms in past week as measured by the Dialysis Symptom Index

Outcome measures

Measure	Dialysis Patients n=8 Participants Patients were recruited from two dialysis units, one located in Manhattan and on in Queens, New York, representing the total dialysis population	Usual Care n=8 Participants Patients were treated to traditional goals in terms of blood pressure, parathyroid hormone and phosphorus
Symptom Burden Baseline	9.00 symptoms Standard Deviation 5.45	13.25 symptoms Standard Deviation 6.88
Symptom Burden 6 weeks	11.00 symptoms Standard Deviation 6.97	9.88 symptoms Standard Deviation 4.45

Adverse Events

Treatment Modification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Dr. Nathaniel Berman

The Rogosin Institute

Phone: 212-746-9766

Email: nab2009@nyp.org

Results disclosure agreements

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