Trial Outcomes & Findings for Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease (NCT NCT00883415)
NCT ID: NCT00883415
Last Updated: 2020-05-21
Results Overview
Change in myocardial glucose uptake from baseline to 6 months expressed as change in micromol/min/100 g
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
6 months
Results posted on
2020-05-21
Participant Flow
Participant milestones
| Measure |
Pre-post Intervention Evaluation
Changes in myocardial glucose uptake were evaluated in each participant before and after anemia treatment with darbepoetin alfa.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Intervention
n=20 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsChange in myocardial glucose uptake from baseline to 6 months expressed as change in micromol/min/100 g
Outcome measures
| Measure |
Intervention
n=18 Participants
|
|---|---|
|
Change to Myocardial Glucose Uptake as Measured by Fluoro-deoxy-D-glucose (FDG) Positron Emission Tomography (PET) Scan From Pre-treatment Compared to 6 Months After Anemia Therapy Initiation.
|
4.49 micromol/min/100g
Interval -6.75 to 15.73
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=20 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Gastric Carcinoma
|
5.0%
1/20 • Number of events 1
|
Additional Information
Jeffrey C. Fink MD, MS; Principal Investigator
University of Maryland Baltimore
Phone: 410-328-4822
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place