Anemia, Cardiomyopathy, Chronic Kidney Disease
Conditions
Keywords
metabolism, myocardium, chronic kidney disease
Brief summary
This study examines patients with chronic kidney disease-related anemia and measures changes in the metabolism of the heart using FDG/PET scanning, before and 6 months after their health-care provider has initiated anemia management therapy with the FDA-approved drug darbepoetin alfa (Aranesp), which is approved for chronic kidney disease-related anemia. The investigators hypothesize that the heart has abnormal metabolism with the anemia of chronic kidney disease but this improves after correction of this anemia with darbepoetin alfa.
Interventions
DRUGDarbepoetin alfa
Subjects will undergo anemia management with darbepoetin after baseline assessment of MGU and will continue for six months with repeat assessment of MGU at completion of protocol
Sponsors
Amgen
University of Maryland, Baltimore
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must receive care at the VAMHCS (VA Hospital) in Baltimore * Diagnosed with CKD stage 3 to 5 (eGFR of 60 ml/min/1.73m2) and not expected to initiate renal replacement therapy within 6 months * Anemia related CKD. * The last 2 serum hemoglobin (Hb) values less than 11.0 gm/dl but greater than 8.0 gm/dl * Greater than 18 years of age * Assessed to be clinically stable by the clinician
Exclusion criteria
* Need for hemodialysis, peritoneal dialysis, or transplantation at the time of enrollment or projected to start within 6 months after enrollment * Low functional capacity including inability to walk a flight of stairs with a bag of groceries (NYHA Class III/IV Heart Failure) * Prior erythropoietic agents within last 12 weeks * TSAT \< 15% and not receiving the recommended dose for iron deficiency * Uncontrolled hypertension defined as greater than 180 mm Hg systolic or 110 mm Hg diastolic * Potentially brittle diabetes with the propensity for symptomatic hypoglycemia after a 6 hour fast * New diagnosis or ongoing therapy for Cancer * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 6 months | Change in myocardial glucose uptake from baseline to 6 months expressed as change in micromol/min/100 g |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Change in myocardial glucose uptake from baseline to 6 months expressed as change in micromol/min/100 g
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | 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 |