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

NCT00883415 | Completed Results

• 2 other identifiers: HP-00041025Amgen ISS#20061907
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy; Chronic Kidney Disease; Anemia

Keywords

metabolism; myocardium; chronic kidney disease

Outcome Measures

Primary Outcomes (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.

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

  6 months

Interventions

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

Also known as: Aranesp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Amgen: collaborator

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Cardiomyopathies; Renal Insufficiency, Chronic; Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Jeffrey C. Fink MD, MS; Principal Investigator
• Organization: University of Maryland Baltimore

jfink@som.umaryland.edu

410-328-4822

Study Officials

• Jeffrey C Fink, MD MS

  University of Maryland School of Medicine and Baltimore VA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Nephrology (primary); Epidemiology (secondary)

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Study Start: May 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 21, 2020
• Results First Posted: May 21, 2020

Record last verified: 2020-05

Locations

US (1)