N/A
N=20
Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease
Cardiomyopathy · Chronic Kidney Disease · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00883415 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: 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. — 4.49 micromol/min/100g
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Darbepoetin alfa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
4.49 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00883415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.