Trial Outcomes & Findings for DBS for Home Monitoring in Children With Kidney Transplantation (NCT NCT01931397)

NCT ID: NCT01931397

Last Updated: 2017-03-17

Results Overview

Mean standard deviation scores for Tacrolimus blood levels obtained by DBS for each patient over time.

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-03-17

Participant Flow

Participant milestones

Measure	Total Cohort This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
Overall Study STARTED	30
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Total Cohort This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	8
Overall Study moved out of state	1

Baseline Characteristics

DBS for Home Monitoring in Children With Kidney Transplantation

Baseline characteristics by cohort

Measure	Total Cohort n=30 Participants This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
Age, Continuous	13.6 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 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	1 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	1 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Number of years post kidney transplantation	5.93 years STANDARD_DEVIATION 4.57 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 9 participants were excluded from final analysis because they submitted two or less evaluable blood samples. A total of 216 DBS samples were received during the study

Mean standard deviation scores for Tacrolimus blood levels obtained by DBS for each patient over time.

Outcome measures

Measure	Total Cohort n=216 blood samples This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.	At End of Study Numbers of families at end of study
Variability of Tacrolimus Blood Levels Measured by DBS Over Time	2.635 ng/ml Standard Deviation 1.086	—

SECONDARY outcome

Timeframe: At baseline and then at 12 months

Population: 25 families participated in the preference survey at time of enrollment and only 15 families completed the survey at the end of the study period (12 months).

The % of families who anticipated preference of DBS method over intravenous blood draws at the time of enrollment and then the % of those who preferred DBS at end of study period (12 months).

Families include parents/caregivers and participants who are over 10 years of age were asked to fill in the preference scale separately.

Preference for DBS Testing was measured using a Visual Analog Scale (VAS) on which a zero was equivalent to no preference for DBS versus laboratory-based monitoring and on which positive numbers indicated greater preference for DBS (up to +72) and negative scores indicated a greater preference for laboratory-based monitoring (down to -72).

Outcome measures

Measure	Total Cohort n=25 Participants This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.	At End of Study n=15 Participants Numbers of families at end of study
Percentage of Families Preferring DBS Method	88 % of families	93 % of families

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 12 months

Population: We analyzed a total of 216 dried blood spots for Tacrolimus blood levels measured in ng/ml

Mean Tacrolimus blood levels obtained by DBS in each patient over their time in the study in children who are 12 years and over versus those less than 12 years of age.

Outcome measures

Measure	Total Cohort n=126 number of blood samples This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.	At End of Study n=90 number of blood samples Numbers of families at end of study
Mean Tacrolimus Blood Levels Measured by DBS Over Study Period According to Age	2.73 ng/ml Standard Deviation 1.21	2.81 ng/ml Standard Deviation 1.16

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline then every 3 months for 12 months

Population: The number of DBS cards expected to be received by those 28 patients were 279 DBS samples.

We will calculate the percent of returned DBS filter papers to OHSU on a monthly basis utilized for TAC and Cr analysis.

we calculated the percentage as the number of DBS that were actually received divided by the total number of DBS expected to be received from participants over the study time period

Outcome measures

Measure	Total Cohort n=279 Total number of DBS cards This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.	At End of Study Numbers of families at end of study
Changes in Adherence Parameters to Home DBS Method	77 percentage of DBS cards	—

Adverse Events

Total Cohort

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. Amira Al-Uzri , Professor of Pediatrics

Oregon Health & Science University

Phone: 503-494-6956

Email: aluzria@ohsu.edu

Results disclosure agreements

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