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

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT00883415
• Collaborator: Amgen (Industry)
• Enrollment: 20
• Location: 1
• Duration (Months): 54
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Phase
Cardiomyopathy; Chronic Kidney Disease; Anemia	Drug: Darbepoetin alfa

Study Design

• 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 1, 2008
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Outcome Measures

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. [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Baltimore VA Medical Center	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore
• Amgen

Investigators

• Principal Investigator: Jeffrey C Fink, MD MS, University of Maryland School of Medicine and Baltimore VA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeffrey Fink, Professor, Nephrology (primary); Epidemiology (secondary), University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT00883415
• Other Study ID Numbers: HP-00041025; Amgen ISS#20061907
• First Posted: Apr 17, 2009
• Last Update Posted: May 21, 2020
• Last Verified: May 1, 2020

• Keywords provided by Jeffrey Fink, Professor, Nephrology (primary); Epidemiology (secondary), University of Maryland, Baltimore: metabolism; myocardium; chronic kidney disease
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Cardiomyopathies; Anemia; Darbepoetin alfa

Study Results

Participant Flow

Arm/Group Title	Pre-post Intervention Evaluation
Arm/Group Description	Changes in myocardial glucose uptake were evaluated in each participant before and after anemia treatment with darbepoetin alfa.
Period Title: Overall Study
STARTED	20
COMPLETED	18
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Intervention
Arm/Group Description
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 35%
>=65 years	13 65%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	20 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	18 90%
White	2 10%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	Change in myocardial glucose uptake from baseline to 6 months expressed as change in micromol/min/100 g
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description
Measure Participants	18
Mean (95% Confidence Interval) [micromol/min/100g]	4.49

Adverse Events

Arm/Group Title	Intervention
Arm/Group Description
All Cause Mortality
	Intervention
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Gastrointestinal disorders
Gastric Carcinoma	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.