End Stage Renal DiseaseNCT03413722
Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors (CNIs) to Everolimus
An observational study of End Stage Renal Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to learn if changing from Tacrolimus to Everolimus will improve cognitive function by having less effect on brain blood flow. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Tacrolimus and Everolimus
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Oct 2022
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential participants will be patients undergoing kidney transplant at the University of Kansas Medical Center.
Who may be able to join
- English speaking
- able to sign informed consent
- able to arrange transportation to and from study site
- without acute stroke, concussion or traumatic brain injury
- without acute medical issues at the time of participation
- At least 12 weeks post Kidney transplant surgery
Who cannot join
- are claustrophobic or have other contra-indication for magnetic resonance imaging (MRI)
- have hearing or visual impairment
- are unable to read, write, speak or understand English
- have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics
- taking Envarsus at the time of recruitment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors to Everolimus
The purpose of this study is to learn if changing from Tacrolimus to Everolimus will improve cognitive function by having less effect on brain blood flow.
- Conditions
- End Stage Renal Disease
- Being tested
- Tacrolimus, Everolimus
- Keywords
- Kidney transplant, Cognitive function
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf
The patient's physician will prescribe drug according to standard practice.
EverolimusDrug
The patient's physician will prescribe drug according to standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Conversion Group | Kidney transplant recipients at the University of Kansas Medical Center (KUMC) who are currently on tacrolimus (CNI), and will be undergoing conversion to Everolimus + low dose CNI. Potential participants will be asked to participate in the study after the decision to convert CNI to Everolimus + low dose CNI has been made. Receives: Drug: Tacrolimus; Drug: Everolimus | |
| Control Group | Kidney transplant recipients at KUMC on tacrolimus (CNI). These will be patients not planning to undergo any change in immunosuppression. Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function
Measured: Change from Baseline to Week 12
Secondary outcomes (1)
Change in cerebral blood flow
Measured: Change from Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Feb 2018
- Primary completion1 Aug 2021
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Aditi Gupta, MD, University of Kansas Medical Center
- Investigators
- Aditi Gupta, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413722
- Sponsor's protocol ID
- STUDY00140594
- Other IDs
- CRAD001AUS211T
- Status last verified
- Oct 2024
- First submitted
- 22 Jan 2018
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors to Everolimus
- ClinicalTrials.gov ID
- NCT03413722
- Acronym / sponsor ID
- STUDY00140594
- Conditions
- End Stage Renal Disease
- Keywords
- Kidney transplant, Cognitive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 29 Jan 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.
The purpose of this study is to learn if changing from Tacrolimus to Everolimus will improve cognitive function by having less effect on brain blood flow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conversion Group | – | Drug: Tacrolimus, Drug: EverolimusKidney transplant recipients at the University of Kansas Medical Center (KUMC) who are currently on tacrolimus (CNI), and will be undergoing conversion to Everolimus + low dose CNI. Potential participants will be asked to participate in the study after the decision to convert CNI to Everolimus + low dose CNI has been made. |
| Control Group | – | Drug: TacrolimusKidney transplant recipients at KUMC on tacrolimus (CNI). These will be patients not planning to undergo any change in immunosuppression. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants will be patients undergoing kidney transplant at the University of Kansas Medical Center.
Key inclusion criteria (6 listed)
- English speaking
- able to sign informed consent
- able to arrange transportation to and from study site
- without acute stroke, concussion or traumatic brain injury
- without acute medical issues at the time of participation
Key exclusion criteria (5 listed)
- are claustrophobic or have other contra-indication for magnetic resonance imaging (MRI)
- have hearing or visual impairment
- are unable to read, write, speak or understand English
- have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics
- taking Envarsus at the time of recruitment
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 |
|---|---|---|
| TacrolimusAlso: PrografThe patient's physician will prescribe drug according to standard practice. | Drug | Control Group, Conversion Group |
| EverolimusThe patient's physician will prescribe drug according to standard practice. | Drug | Conversion Group |
Primary outcome
Change in cognitive function
Time frame: Change from Baseline to Week 12
1 secondary outcome
Change in cerebral blood flow
Time frame: Change from Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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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.
Aditi Gupta, MD principal investigator
University of Kansas Medical Center
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 End Stage Renal Disease, run by University of Kansas Medical Center 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 5 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 22 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in cognitive function (time frame: Change from Baseline to Week 12). 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 22 Oct 2024.