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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
History of Changes
  Purpose

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 Intervention Phase
Cardiomyopathy
Chronic Kidney Disease
Anemia
 Drug: Darbepoetin alfa
 Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: May 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883415

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

No publications provided

Responsible Party: Jeffrey C Fink, Professor, Nephrology (primary); Epidemiology (secondary), University of Maryland
ClinicalTrials.gov Identifier: NCT00883415     History of Changes
Other Study ID Numbers: HP-00041025, Amgen ISS#20061907
Study First Received: April 16, 2009
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
metabolism
myocardium
chronic kidney disease

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Cardiomyopathies
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
 Heart Diseases
Cardiovascular Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013