Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate the Effect of the Treatment of Anemia on Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease

Conditions
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Cardiomyopathy, Chronic Kidney Disease, Anemia

Intervention / Treatment
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* Drug: Darbepoetin alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darbepoetin 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolism, myocardium, chronic kidney disease