Complication of Renal DialysisARChIVEDNCT02764736
Atorvastatin Reduces Chronic Inflammation and aVerage Epogen Dose (ARChIVED)
A study testing Atorvastatin in people with Complication of Renal Dialysis, run by Albert Einstein Healthcare Network.
Trial summary
The specific aim of this trial is to determine whether initiating moderate- or high-intensity atorvastatin therapy in hemodialysis patient not previously on a statin reduces inflammation and lowers average Epogen utilization. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Complication of Renal Dialysis
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2016to 22 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable on Hemoglobin levels on Epogen therapy (Hgb between 9.5-11.5 for prior 3 weeks)
- No statin usage during the prior 3 months
- Complaint with hemodialysis and medications
Who cannot join
- Prior history of myocardial infarction, stroke or vascular disease
- Prior hospitalization within the past 15 days
- Prior episodes of significant bleeding (trauma, GI bleed, GU bleed, menorrhagia) in the prior 15 days
- Liver disease
- Active malignancy
- Hematologic disorder
About this study
The specific aim of this trial is to determine whether initiating moderate- or high-intensity atorvastatin therapy in hemodialysis patient not previously on a statin reduces inflammation and lowers average Epogen utilization. Statin naive patients on maintenance HD will be started on 20mg atorvastatin daily for weeks and then titrated up to 40mg atorvastatin daily for an additional 12 weeks. Patient's inflammatory markers (ferritin, CRP) and weekly Epogen usage will be monitored.
Read the detailed description
Patients will be identified and consented. After informed consent is obtained, baseline demographic information, past medical history, dialysis specific information, and laboratory metrics (lipid profile, inflammatory markers) will be obtained from the electronic medical records. For the first 12 weeks, all subjects will be instructed to take one 20mg atorvastatin tablet daily; atorvastatin tablets will be dispensed by the research team in 30-tablet increments every month to ensure compliance and prevent diversion. Subjects will undergo standard-of-care hemodialysis with routine hemoglobin monitoring and Epogen titration according to the dialysis center protocol. Every two weeks, they will be assessed by a research coordinator who will monitor for medication adverse effects (see attached patient survey) and medication compliance (pill counts) at alternating visits. After 12 weeks, lipid profile and inflammatory markers will be rechecked or obtained from the electronic medical record. For the subsequent 12 weeks (ie. weeks 12-24), subjects will be instructed to take two 20mg atorvastatin tablets (40mg total) daily. If the subject is unable to tolerate 40mg of atorvastatin daily due to medication adverse effects, they will continue to take 20mg atorvastatin daily for the remainder of the trial. Epogen will be titrated and subjects will be monitored as above. At the completion of the study, a lipid panel and inflammatory markers will be checked for a third time. Epogen usage and dialysis specific information will be recorded continuously throughout the study.
- Conditions
- Complication of Renal Dialysis
- Being tested
- Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Statin
Patients will be given 20mg atorvastatin daily for 12 weeks and then increased to 40mg atorvastatin daily for an additional 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin | Experimental | Patients in this arm will receive 20mg atorvastatin PO daily for 12 weeks followed by 40mg atorvastatin PO daily for 12 weeks. Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epoetin alfa (Epogen) utilization measured in units per week
The amount of epoetin alfa, measured in units, needed to maintain a patient's hemoglobin between 11.0 and 12.0 gm/dL
Measured: 24 weeks
Secondary outcomes (2)
C-reactive protein, ferritin levels
Measured: 24 weeks
Total cholesterol level, LDL level, HDL level
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start4 Mar 2016
- Primary completion22 Mar 2017
- Study completion22 Mar 2017
Why it stopped: Enrollment did not progress as anticipated. No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Renal DialysisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pradhum Ram, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764736
- Sponsor's protocol ID
- 4802
- Acronym
- ARChIVED
- Status last verified
- May 2017
- First submitted
- 18 Mar 2016
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin Reduces Chronic Inflammation and aVerage Epogen Dose (ARChIVED)
- ClinicalTrials.gov ID
- NCT02764736
- Acronym / sponsor ID
- ARChIVED / 4802
- Conditions
- Complication of Renal Dialysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment did not progress as anticipated. No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 22 Mar 2017 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of this trial is to determine whether initiating moderate- or high-intensity atorvastatin therapy in hemodialysis patient not previously on a statin reduces inflammation and lowers average Epogen utilization. Statin naive patients on maintenance HD will be started on 20mg atorvastatin daily for weeks and then titrated up to 40mg atorvastatin daily for an additional 12 weeks. Patient's inflammatory markers (ferritin, CRP) and weekly Epogen usage will be monitored.
Detailed description
Patients will be identified and consented. After informed consent is obtained, baseline demographic information, past medical history, dialysis specific information, and laboratory metrics (lipid profile, inflammatory markers) will be obtained from the electronic medical records. For the first 12 weeks, all subjects will be instructed to take one 20mg atorvastatin tablet daily; atorvastatin tablets will be dispensed by the research team in 30-tablet increments every month to ensure compliance and prevent diversion. Subjects will undergo standard-of-care hemodialysis with routine hemoglobin monitoring and Epogen titration according to the dialysis center protocol. Every two weeks, they will be assessed by a research coordinator who will monitor for medication adverse effects (see attached patient survey) and medication compliance (pill counts) at alternating visits. After 12 weeks, lipid profile and inflammatory markers will be rechecked or obtained from the electronic medical record. For the subsequent 12 weeks (ie. weeks 12-24), subjects will be instructed to take two 20mg atorvastatin tablets (40mg total) daily. If the subject is unable to tolerate 40mg of atorvastatin daily due to medication adverse effects, they will continue to take 20mg atorvastatin daily for the remainder of the trial. Epogen will be titrated and subjects will be monitored as above. At the completion of the study, a lipid panel and inflammatory markers will be checked for a third time. Epogen usage and dialysis specific information will be recorded continuously throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atorvastatin | Experimental | Drug: AtorvastatinPatients in this arm will receive 20mg atorvastatin PO daily for 12 weeks followed by 40mg atorvastatin PO daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable on Hemoglobin levels on Epogen therapy (Hgb between 9.5-11.5 for prior 3 weeks)
- No statin usage during the prior 3 months
- Complaint with hemodialysis and medications
Key exclusion criteria (6 listed)
- Prior history of myocardial infarction, stroke or vascular disease
- Prior hospitalization within the past 15 days
- Prior episodes of significant bleeding (trauma, GI bleed, GU bleed, menorrhagia) in the prior 15 days
- Liver disease
- Active malignancy
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 |
|---|---|---|
| AtorvastatinAlso: StatinPatients will be given 20mg atorvastatin daily for 12 weeks and then increased to 40mg atorvastatin daily for an additional 12 weeks. | Drug | atorvastatin |
Primary outcome
Epoetin alfa (Epogen) utilization measured in units per week
Time frame: 24 weeks
The amount of epoetin alfa, measured in units, needed to maintain a patient's hemoglobin between 11.0 and 12.0 gm/dL
2 secondary outcomes
C-reactive protein, ferritin levels
Time frame: 24 weeks
Total cholesterol level, LDL level, HDL level
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin in people with Complication of Renal Dialysis, run by Albert Einstein Healthcare Network.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Epoetin alfa (Epogen) utilization measured in units per week (time frame: 24 weeks). 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 18 May 2017.