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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883415
• Other study ID #: HP-00041025
• Secondary ID: Amgen ISS#200619
• Status: Completed
• Start date: May 2008
• Est. completion date: November 2012

Study information

• Verified date: May 2020
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Cardiomyopathies
• Cardiomyopathy
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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