- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00883415
Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease
May 11, 2020 updated by: Jeffrey Fink, University of Maryland, Baltimore
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Baltimore VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change in myocardial glucose uptake from baseline to 6 months expressed as change in micromol/min/100 g
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jeffrey C Fink, MD MS, University of Maryland School of Medicine and Baltimore VA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
April 16, 2009
First Submitted That Met QC Criteria
April 16, 2009
First Posted (Estimate)
April 17, 2009
Study Record Updates
Last Update Posted (Actual)
May 21, 2020
Last Update Submitted That Met QC Criteria
May 11, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00041025
- Amgen ISS#20061907
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia
-
SanofiActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)United States, Austria, China, Denmark, Germany, Hungary, Italy, Spain, United Kingdom
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
-
Hospital Universitario Dr. Jose E. GonzalezCompletedPernicious Anemia | Megaloblastic Anemia NosMexico
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
Abdelwahed, Mai Mahmoud Mohamed, M.D.UnknownAnemia During PregnancyEgypt
-
University of California, DavisInstituto Mexicano del Seguro Social; Thrasher Research Fund; Mexican National... and other collaboratorsCompleted
-
Incyte CorporationActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)Spain, United States, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, United Kingdom
-
Peking Union Medical College HospitalRecruiting
-
Alexion PharmaceuticalsWithdrawnWarm Autoimmune Hemolytic AnemiaUnited States
Clinical Trials on Darbepoetin alfa
-
AmgenCompletedAnemia | Non-Myeloid Malignancies
-
University of New MexicoUniversity of UtahCompletedHypoxic-Ischemic Encephalopathy Mild | Neonatal EncephalopathyUnited States
-
The Hospital for Sick ChildrenCompletedKidney Failure, ChronicCanada
-
AmgenCompleted
-
Kyowa Kirin Co., Ltd.Completed
-
AmgenCompletedLymphoma | Breast Neoplasms | Lung Neoplasms | Multiple Myeloma | Chronic Lymphocytic Leukemia