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

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.

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Key information

Conditions

Cardiomyopathy Anemia Cardiomyopathies Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

darbepoetin alfa

Drug

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

Other names: Aranesp

Primary outcomes

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.

Time frame: 6 months

Change in myocardial glucose uptake from baseline to 6 months expressed as change in micromol/min/100 g

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

Amgen

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Apr 17, 2009
Registry last updated: May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed