CardiomyopathyNCT00883415
Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease
An observational study of Cardiomyopathy and Chronic Kidney Disease, run by University of Maryland, Baltimore at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Chronic Kidney Disease, Anemia
- What is being tested?
- Darbepoetin alfa
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Nov 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
About this study
Official title: 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.
- Conditions
- Cardiomyopathy, Chronic Kidney Disease, Anemia
- Being tested
- Darbepoetin alfa
- Keywords
- metabolism, myocardium, chronic kidney disease
- Medical subject headings
- Cardiomyopathies, Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Also called Aranesp
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startMay 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Jeffrey Fink, University of Maryland, Baltimore
- Investigators
- Jeffrey C Fink, MD MS, Principal investigator, University of Maryland School of Medicine and Baltimore VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883415
- Sponsor's protocol ID
- HP-00041025
- Other IDs
- Amgen ISS#20061907
- Status last verified
- May 2020
- First submitted
- 16 Apr 2009
- Last updated
- 21 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of the Treatment of Anemia on Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00883415
- Acronym / sponsor ID
- HP-00041025
- Conditions
- Cardiomyopathy, Chronic Kidney Disease, Anemia
- Keywords
- metabolism, myocardium, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- May 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Posted 21 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darbepoetin alfaAlso: AranespSubjects 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 | Drug | – |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey C Fink, MD MS principal investigator
University of Maryland School of Medicine and Baltimore VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy and Chronic Kidney Disease, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.