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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Jeffrey C Fink, University of Maryland
ClinicalTrials.gov Identifier:
NCT00883415
First received: April 16, 2009
Last updated: September 19, 2012
Last verified: September 2012

April 16, 2009
September 19, 2012
May 2008
March 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00883415 on ClinicalTrials.gov Archive Site
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Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease
A Study to Evaluate the Effect of the Treatment of Anemia on 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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Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Cardiomyopathy
  • Chronic Kidney Disease
  • Anemia
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00883415
HP-00041025, Amgen ISS#20061907
No
Jeffrey C Fink, University of Maryland
University of Maryland
Amgen
Principal Investigator: Jeffrey C Fink, MD MS University of Maryland School of Medicine and Baltimore VA
University of Maryland
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP