ESRDPhase 4NCT03663049
The Impact of Statin Holiday in Dialysis Patients Over 70 Years Old on Mental Function, Physical Function and Frailty
A Phase 4 study testing discontinue statin in people with ESRD and Cardiovascular Diseases, run by Loyola University at 1 site in United States.
Trial summary
Patients who are on chronic dialysis and 70 and older are frequently on multiple medications including statins. However, the benefit of statins in dialysis patient population is uncertain. Several randomized trials showed no benefit of statins on mortality in dialysis patient population. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- ESRD, Cardiovascular Diseases
- What is being tested?
- discontinue statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2018to May 2021
- Phase
- Phase 4
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 70 years and older,
- Receiving maintenance dialysis for at least 6 months,
- Must be on a statin medication,
- Receiving dialysis at the Loyola University Medical Center dialysis unit ,
- Can be on hemodialysis or peritoneal dialysis,
Who cannot join
- Age less than 70 years old
- Any recent hospital admission (within 2 weeks)
- Recent dialysis start (within 6 months)
- Any cancer diagnosis, with exception of innocuous skin cancers and previously treated cancers
- Any recent (< 1 year) solid organ transplant
- Active on kidney transplant wait list
Show all 10Show fewer
- Recent acute coronary event (e.g. recent NSTEMI, stent, angioplasty, CABG) within 6 months
- Non-English speaking
- Diagnosis of dementia
- Patients who are unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Loyola University M Center, 708-216-9000, julia.schneider@luhs.org
About this study
Official title: Trial of Statin Holiday in Patients Receiving Maintenance Dialysis
Patients who are on chronic dialysis and 70 and older are frequently on multiple medications including statins. However, the benefit of statins in dialysis patient population is uncertain. Several randomized trials showed no benefit of statins on mortality in dialysis patient population. Guidelines recommend not starting statins in patients on dialysis who are not already taking them. However, there are no guidelines on what to do in patients who are already taking statins. The investigators are doing a short pilot study to discontinue statin in our dialysis patient population and evaluating the effects on discontinuation of statins on quality of life, cognition, as physical strength.
Read the detailed description
Dialysis patients who are 70 years and older suffer from cognitive dysfunction, physical impairment, and frailty. Polypharmacy in this subgroup of patients is prevalent and can lead to drug toxicities and increased side effects which can contribute to adverse outcomes such as worsening cognitive decline and increased frailty. One frequent component of polypharmacy in dialysis patient population is the use of statins. The use of statins, however, has not been proven to be beneficial in this patient population. While statin medications have been shown to reduce atherosclerotic cardiovascular disease in adults without dialysis dependent chronic kidney disease (CKD), the benefit of statin use in chronic dialysis patients has not been proven. A Cochrane meta-analysis published in 2013 included 25 trials of statin medications in patients receiving maintenance dialysis (total of 8289 patients) and found no benefit of statin medications for preventing atherosclerotic cardiovascular disease events or mortality. The meta-analysis did note that evidence for side effects for statins was incomplete and potential harms from statin medications remain uncertain in this population. Furthermore, statins have recently come under scrutiny by the FDA with regards to their safety due to associations with memory loss and weakness.
Previous clinical trials of statins only assessed the known adverse effects of statins such as abnormal liver function tests and acute kidney injury, adverse effects that occur rarely (< 1%). Trials did not assess other side effects such as cognitive decline or muscle weakness that may be more common in older patients with kidney failure. The aim of this pilot study is to examine the potential side effects of statin medication use in older patients receiving dialysis by conducting a randomized pilot trial of a statin holiday (3 months of discontinuation) vs. no holiday and measuring changes in cognitive function, muscle strength, quality of life and frailty. The investigators hypothesize that measures of cognitive function, grip strength, quality of life and overall frailty will improve after 6 weeks of discontinuation of statins. After obtaining informed consent, patients will complete assessments of quality of life (SF-20), cognition, muscle strength and frailty at baseline and again at 6 and 12 weeks after statin holiday (intervention group) vs. no statin holiday (control group). All patients will resume statin medications after the 3 month trial. The overall goal is to determine whether changes in cognition, strength, frailty or quality of life can be measured using standard instruments. If changes can be detected, pilot data from this study will be used to design a larger trial.
- Conditions
- ESRD, Cardiovascular Diseases
- Being tested
- discontinue statin
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discontinue statinDrug
Discontinue statin as prescribed for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | These patients will continue as statins as usual. |
| Discontinue statin | Experimental | Patients randomized to this group will stop using the statins they are currently prescribed and will not use their statin medication for 12 weeks. Receives: Drug: discontinue statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
Change in quality of life will be measured by the Short Form Survey 20 (SF-20). The survey assesses quality of life via 20 questions across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question). Scores across each of these domains are reported on a 0% to 100% scale, with 0% representing the worst possible score in that domain and 100% the best possible score.
Measured: Change in quality of life over 12 weeks
Secondary outcomes (1)
Change in handgrip strength
Handgrip strength will be measured at baseline and again at 6 and 12 weeks
Measured: Change in handgrip strength over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start17 Aug 2018
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for ESRDStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms in the study. Patients will be randomized to either continue medication in the statin group or discontinue.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Schneider, Loyola University
- Investigators
- Julia Schneider, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663049
- Sponsor's protocol ID
- 210890
- Status last verified
- Apr 2019
- First submitted
- 6 Sep 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clark DA, Khan U, Kiberd BA, Turner CC, Dixon A, Landry D, Moffatt HC, Moorhouse PA, Tennankore KK. Frailty in end-stage renal disease: comparing patient, caregiver, and clinician perspectives. BMC Nephrol. 2017 May 2;18(1):148. doi: 10.1186/s12882-017-0558-x.
PubMed 28464924McIntyre C, McQuillan R, Bell C, Battistella M. Targeted Deprescribing in an Outpatient Hemodialysis Unit: A Quality Improvement Study to Decrease Polypharmacy. Am J Kidney Dis. 2017 Nov;70(5):611-618. doi: 10.1053/j.ajkd.2017.02.374. Epub 2017 Apr 14.
PubMed 28416321St Peter WL. Management of Polypharmacy in Dialysis Patients. Semin Dial. 2015 Jul-Aug;28(4):427-32. doi: 10.1111/sdi.12377. Epub 2015 Apr 9.
PubMed 25864928Fellstrom BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Gronhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Suleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wuthrich RP, Gottlow M, Johnsson E, Zannad F; AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407. doi: 10.1056/NEJMoa0810177. Epub 2009 Mar 30.
PubMed 19332456Holdaas H, Holme I, Schmieder RE, Jardine AG, Zannad F, Norby GE, Fellstrom BC; AURORA study group. Rosuvastatin in diabetic hemodialysis patients. J Am Soc Nephrol. 2011 Jul;22(7):1335-41. doi: 10.1681/ASN.2010090987. Epub 2011 May 12.
PubMed 21566054Baigent C, Landray MJ, Reith C, Emberson J, Wheeler DC, Tomson C, Wanner C, Krane V, Cass A, Craig J, Neal B, Jiang L, Hooi LS, Levin A, Agodoa L, Gaziano M, Kasiske B, Walker R, Massy ZA, Feldt-Rasmussen B, Krairittichai U, Ophascharoensuk V, Fellstrom B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Gronhagen-Riska C, Dasgupta T, Lewis D, Herrington W, Mafham M, Majoni W, Wallendszus K, Grimm R, Pedersen T, Tobert J, Armitage J, Baxter A, Bray C, Chen Y, Chen Z, Hill M, Knott C, Parish S, Simpson D, Sleight P, Young A, Collins R; SHARP Investigators. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011 Jun 25;377(9784):2181-92. doi: 10.1016/S0140-6736(11)60739-3. Epub 2011 Jun 12.
PubMed 21663949Olyaei A, Steffl JL, MacLaughlan J, Trabolsi M, Quadri SP, Abbasi I, Lerma E. HMG-CoA reductase inhibitors in chronic kidney disease. Am J Cardiovasc Drugs. 2013 Dec;13(6):385-98. doi: 10.1007/s40256-013-0041-4.
PubMed 23975627Wanner C, Tonelli M; Kidney Disease: Improving Global Outcomes Lipid Guideline Development Work Group Members. KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient. Kidney Int. 2014 Jun;85(6):1303-9. doi: 10.1038/ki.2014.31. Epub 2014 Feb 19.
PubMed 24552851Manley HJ, McClaran ML, Overbay DK, Wright MA, Reid GM, Bender WL, Neufeld TK, Hebbar S, Muther RS. Factors associated with medication-related problems in ambulatory hemodialysis patients. Am J Kidney Dis. 2003 Feb;41(2):386-93. doi: 10.1053/ajkd.2003.50048.
PubMed 12552501Talar Markossian, Holly Kramer, Nicholas Burge, et a. Utilization of statins in U.S. Veterans with dialysis-dependent chronic kidney disease. Health Sciences Research. 2018 Under review
Kurella Tamura M, Larive B, Unruh ML, Stokes JB, Nissenson A, Mehta RL, Chertow GM; Frequent Hemodialysis Network Trial Group. Prevalence and correlates of cognitive impairment in hemodialysis patients: the Frequent Hemodialysis Network trials. Clin J Am Soc Nephrol. 2010 Aug;5(8):1429-38. doi: 10.2215/CJN.01090210. Epub 2010 Jun 24.
PubMed 20576825Johansen KL, Chertow GM, Jin C, Kutner NG. Significance of frailty among dialysis patients. J Am Soc Nephrol. 2007 Nov;18(11):2960-7. doi: 10.1681/ASN.2007020221. Epub 2007 Oct 17. No abstract available.
PubMed 17942958Herzog CA, Asinger RW, Berger AK, Charytan DM, Diez J, Hart RG, Eckardt KU, Kasiske BL, McCullough PA, Passman RS, DeLoach SS, Pun PH, Ritz E. Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2011 Sep;80(6):572-86. doi: 10.1038/ki.2011.223. Epub 2011 Jul 13.
PubMed 21750584Isoyama N, Qureshi AR, Avesani CM, Lindholm B, Barany P, Heimburger O, Cederholm T, Stenvinkel P, Carrero JJ. Comparative associations of muscle mass and muscle strength with mortality in dialysis patients. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1720-8. doi: 10.2215/CJN.10261013. Epub 2014 Jul 29.
PubMed 25074839Dong J, Pi HC, Xiong ZY, Liao JL, Hao L, Liu GL, Ren YP, Wang Q, Duan LP, Zheng ZX. Depression and Cognitive Impairment in Peritoneal Dialysis: A Multicenter Cross-sectional Study. Am J Kidney Dis. 2016 Jan;67(1):111-8. doi: 10.1053/j.ajkd.2015.06.025. Epub 2015 Aug 6.
PubMed 26255306
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Statin Holiday in Patients Receiving Maintenance Dialysis
- ClinicalTrials.gov ID
- NCT03663049
- Acronym / sponsor ID
- 210890
- Conditions
- ESRD, Cardiovascular Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 10 Sep 2018 (actual)
- 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.
Patients who are on chronic dialysis and 70 and older are frequently on multiple medications including statins. However, the benefit of statins in dialysis patient population is uncertain. Several randomized trials showed no benefit of statins on mortality in dialysis patient population. Guidelines recommend not starting statins in patients on dialysis who are not already taking them. However, there are no guidelines on what to do in patients who are already taking statins. The investigators are doing a short pilot study to discontinue statin in our dialysis patient population and evaluating the effects on discontinuation of statins on quality of life, cognition, as physical strength.
Detailed description
Dialysis patients who are 70 years and older suffer from cognitive dysfunction, physical impairment, and frailty. Polypharmacy in this subgroup of patients is prevalent and can lead to drug toxicities and increased side effects which can contribute to adverse outcomes such as worsening cognitive decline and increased frailty. One frequent component of polypharmacy in dialysis patient population is the use of statins. The use of statins, however, has not been proven to be beneficial in this patient population. While statin medications have been shown to reduce atherosclerotic cardiovascular disease in adults without dialysis dependent chronic kidney disease (CKD), the benefit of statin use in chronic dialysis patients has not been proven. A Cochrane meta-analysis published in 2013 included 25 trials of statin medications in patients receiving maintenance dialysis (total of 8289 patients) and found no benefit of statin medications for preventing atherosclerotic cardiovascular disease events or mortality. The meta-analysis did note that evidence for side effects for statins was incomplete and potential harms from statin medications remain uncertain in this population. Furthermore, statins have recently come under scrutiny by the FDA with regards to their safety due to associations with memory loss and weakness.
Previous clinical trials of statins only assessed the known adverse effects of statins such as abnormal liver function tests and acute kidney injury, adverse effects that occur rarely (< 1%). Trials did not assess other side effects such as cognitive decline or muscle weakness that may be more common in older patients with kidney failure. The aim of this pilot study is to examine the potential side effects of statin medication use in older patients receiving dialysis by conducting a randomized pilot trial of a statin holiday (3 months of discontinuation) vs. no holiday and measuring changes in cognitive function, muscle strength, quality of life and frailty. The investigators hypothesize that measures of cognitive function, grip strength, quality of life and overall frailty will improve after 6 weeks of discontinuation of statins. After obtaining informed consent, patients will complete assessments of quality of life (SF-20), cognition, muscle strength and frailty at baseline and again at 6 and 12 weeks after statin holiday (intervention group) vs. no statin holiday (control group). All patients will resume statin medications after the 3 month trial. The overall goal is to determine whether changes in cognition, strength, frailty or quality of life can be measured using standard instruments. If changes can be detected, pilot data from this study will be used to design a larger trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms in the study. Patients will be randomized to either continue medication in the statin group or discontinue.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –These patients will continue as statins as usual. |
| Discontinue statin | Experimental | Drug: discontinue statinPatients randomized to this group will stop using the statins they are currently prescribed and will not use their statin medication for 12 weeks. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 70 years and older,
- Receiving maintenance dialysis for at least 6 months,
- Must be on a statin medication,
- Receiving dialysis at the Loyola University Medical Center dialysis unit ,
- Can be on hemodialysis or peritoneal dialysis,
Key exclusion criteria (10 listed)
- Age less than 70 years old
- Any recent hospital admission (within 2 weeks)
- Recent dialysis start (within 6 months)
- Any cancer diagnosis, with exception of innocuous skin cancers and previously treated cancers
- Any recent (< 1 year) solid organ transplant
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 |
|---|---|---|
| discontinue statinDiscontinue statin as prescribed for 12 weeks | Drug | Discontinue statin |
Primary outcome
Change in quality of life
Time frame: Change in quality of life over 12 weeks
Change in quality of life will be measured by the Short Form Survey 20 (SF-20). The survey assesses quality of life via 20 questions across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question). Scores across each of these domains are reported on a 0% to 100% scale, with 0% representing the worst possible score in that domain and 100% the best possible score.
1 secondary outcome
Change in handgrip strength
Time frame: Change in handgrip strength over 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Background: PubMed 28464924Clark DA, Khan U, Kiberd BA, Turner CC, Dixon A, Landry D, Moffatt HC, Moorhouse PA, Tennankore KK. Frailty in end-stage renal disease: comparing patient, caregiver, and clinician perspectives. BMC Nephrol. 2017 May 2;18(1):148. doi: 10.1186/s12882-017-0558-x.
- Background: PubMed 28416321McIntyre C, McQuillan R, Bell C, Battistella M. Targeted Deprescribing in an Outpatient Hemodialysis Unit: A Quality Improvement Study to Decrease Polypharmacy. Am J Kidney Dis. 2017 Nov;70(5):611-618. doi: 10.1053/j.ajkd.2017.02.374. Epub 2017 Apr 14.
- Background: PubMed 25864928St Peter WL. Management of Polypharmacy in Dialysis Patients. Semin Dial. 2015 Jul-Aug;28(4):427-32. doi: 10.1111/sdi.12377. Epub 2015 Apr 9.
- Background: PubMed 19332456Fellstrom BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Gronhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Suleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wuthrich RP, Gottlow M, Johnsson E, Zannad F; AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407. doi: 10.1056/NEJMoa0810177. Epub 2009 Mar 30.
- Background: PubMed 21566054Holdaas H, Holme I, Schmieder RE, Jardine AG, Zannad F, Norby GE, Fellstrom BC; AURORA study group. Rosuvastatin in diabetic hemodialysis patients. J Am Soc Nephrol. 2011 Jul;22(7):1335-41. doi: 10.1681/ASN.2010090987. Epub 2011 May 12.
- Background: PubMed 21663949Baigent C, Landray MJ, Reith C, Emberson J, Wheeler DC, Tomson C, Wanner C, Krane V, Cass A, Craig J, Neal B, Jiang L, Hooi LS, Levin A, Agodoa L, Gaziano M, Kasiske B, Walker R, Massy ZA, Feldt-Rasmussen B, Krairittichai U, Ophascharoensuk V, Fellstrom B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Gronhagen-Riska C, Dasgupta T, Lewis D, Herrington W, Mafham M, Majoni W, Wallendszus K, Grimm R, Pedersen T, Tobert J, Armitage J, Baxter A, Bray C, Chen Y, Chen Z, Hill M, Knott C, Parish S, Simpson D, Sleight P, Young A, Collins R; SHARP Investigators. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011 Jun 25;377(9784):2181-92. doi: 10.1016/S0140-6736(11)60739-3. Epub 2011 Jun 12.
- Background: PubMed 23975627Olyaei A, Steffl JL, MacLaughlan J, Trabolsi M, Quadri SP, Abbasi I, Lerma E. HMG-CoA reductase inhibitors in chronic kidney disease. Am J Cardiovasc Drugs. 2013 Dec;13(6):385-98. doi: 10.1007/s40256-013-0041-4.
- Background: PubMed 24552851Wanner C, Tonelli M; Kidney Disease: Improving Global Outcomes Lipid Guideline Development Work Group Members. KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient. Kidney Int. 2014 Jun;85(6):1303-9. doi: 10.1038/ki.2014.31. Epub 2014 Feb 19.
- Background: PubMed 12552501Manley HJ, McClaran ML, Overbay DK, Wright MA, Reid GM, Bender WL, Neufeld TK, Hebbar S, Muther RS. Factors associated with medication-related problems in ambulatory hemodialysis patients. Am J Kidney Dis. 2003 Feb;41(2):386-93. doi: 10.1053/ajkd.2003.50048.
- BackgroundTalar Markossian, Holly Kramer, Nicholas Burge, et a. Utilization of statins in U.S. Veterans with dialysis-dependent chronic kidney disease. Health Sciences Research. 2018 Under review
- Background: PubMed 20576825Kurella Tamura M, Larive B, Unruh ML, Stokes JB, Nissenson A, Mehta RL, Chertow GM; Frequent Hemodialysis Network Trial Group. Prevalence and correlates of cognitive impairment in hemodialysis patients: the Frequent Hemodialysis Network trials. Clin J Am Soc Nephrol. 2010 Aug;5(8):1429-38. doi: 10.2215/CJN.01090210. Epub 2010 Jun 24.
- Background: PubMed 17942958Johansen KL, Chertow GM, Jin C, Kutner NG. Significance of frailty among dialysis patients. J Am Soc Nephrol. 2007 Nov;18(11):2960-7. doi: 10.1681/ASN.2007020221. Epub 2007 Oct 17. No abstract available.
- Drug Safety and Availability - FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs \[Internet\].: Center for Drug Evaluation and Research \[cited Mar 9, 2018\]Link provided by the sponsor.
- 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.
Julia Schneider principal investigator
Loyola University Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing discontinue statin in people with ESRD and Cardiovascular Diseases, run by Loyola University 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Apr 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia M Schneider (7082169000, julia.schneider@luhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: Change in quality of life over 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663049, which also lists 20 linked publications.
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 23 Apr 2019.