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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00883415
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Jeffrey Fink, University of Maryland

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.

Condition or disease Intervention/treatment
Cardiomyopathy Chronic Kidney Disease Anemia Drug: Darbepoetin alfa

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: A Study to Evaluate the Effect of the Treatment of Anemia on Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease
Study Start Date : May 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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
    Other Name: Aranesp

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of individuals being followed for their chronic kidney disease (CKD) at one of the Nephrology/Early Renal Insufficiency Clinics at the Baltimore, Maryland VA Medical Center and are being considered for erthropoietin therapy for anemia related to CKD.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00883415

United States, Maryland
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Principal Investigator: Jeffrey C Fink, MD MS University of Maryland School of Medicine and Baltimore VA

Responsible Party: Jeffrey Fink, Professor, Nephrology (primary); Epidemiology (secondary), University of Maryland Identifier: NCT00883415     History of Changes
Other Study ID Numbers: HP-00041025
Amgen ISS#20061907
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Jeffrey Fink, University of Maryland:
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Darbepoetin alfa