Trial Outcomes & Findings for Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose (NCT NCT01263028)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

24 Weeks

Results posted on

2015-03-30

Participant Flow

Recruitment began in February 2011 at Kaiser Permanente Los Angeles Medical Center. Despite strong enrollment efforts only 6 particiants were enrolled out of 10 screened.

Participants were assessed for study inclusion based on chronic kidney disease (CKD) stage, age, current vitamin D levels \<30 ng/ml as well as history of vitamin D levels \< 30, and stable dose of erythropoietin and iron.

Participant milestones

Participant milestones
Measure	Ergocalciferol Supplementation
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ergocalciferol Supplementation
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1
Overall Study Study terminated due to low enrollment.	4

Baseline Characteristics

Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ergocalciferol Supplementation n=6 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Region of Enrollment United States	6 participants n=99 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Weeks

Outcome measures

Outcome data not reported

Adverse Events

Ergocalciferol Supplementation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ergocalciferol Supplementation n=6 participants at risk
Blood and lymphatic system disorders Low Hemoglobin	16.7% 1/6 • Number of events 1 • 36 Weeks

Additional Information

John J. Sim, MD

Kaiser Permanente

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place