Chronic Kidney DiseasesNCT06107166
Testosterone and Vascular Function in Reproductive-Aged Females With Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Cardiovascular Diseases, run by University of Calgary at 1 site in Canada.
Trial summary
Cardiovascular disease (CVD) is the leading cause of death among women and women with chronic kidney disease are at an even greater risk of CVD. The aim of this observational study is to examine the relationship between total testosterone levels and measures of vascular function (pulse wave velocity, aortic… Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Chronic Kidney Diseases, Cardiovascular Diseases
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 31 Dec 2021
- 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 51 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will include stable females of reproductive age (18-51 years of age) with chronic kidney disease. Subjects will require permission of their primary nephrologist or primary care provider to participate
Who may be able to join
- female sex
- a diagnosis of chronic kidney disease or end stage kidney disease
- age 18-51
Who cannot join
- Pregnancy, breastfeeding, current use of menopausal hormone therapy or gender affirming hormone therapy, or factors that would affect ovarian function, such as polycystic ovarian syndrome, premature ovarian insufficiency, ovarian malignancy, gonadotoxic chemotherapy, surgical oophorectomy, or previous radiation to the pelvis.
Trial locations and contacts
1 site in 1 country.
About this study
Cardiovascular disease (CVD) is the leading cause of death among women and women with chronic kidney disease are at an even greater risk of CVD. The aim of this observational study is to examine the relationship between total testosterone levels and measures of vascular function (pulse wave velocity, aortic augmentation index, flow mediated dilation and velocity time integral) in reproductive-aged women living with chronic kidney disease.
- Conditions
- Chronic Kidney Diseases, Cardiovascular Diseases
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Measured: Measured at baseline
Aortic augmentation index
Measured: Measured at baseline
Flow mediated dilation
Measured: Measured at baseline
Velocity time integral
Measured: Measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jun 2018
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Dumanski, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107166
- Sponsor's protocol ID
- REB18-0642
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone and Vascular Function in Reproductive-Aged Females With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06107166
- Acronym / sponsor ID
- REB18-0642
- Conditions
- Chronic Kidney Diseases, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Oct 2023 (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.
Cardiovascular disease (CVD) is the leading cause of death among women and women with chronic kidney disease are at an even greater risk of CVD. The aim of this observational study is to examine the relationship between total testosterone levels and measures of vascular function (pulse wave velocity, aortic augmentation index, flow mediated dilation and velocity time integral) in reproductive-aged women living with chronic kidney disease.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will include stable females of reproductive age (18-51 years of age) with chronic kidney disease. Subjects will require permission of their primary nephrologist or primary care provider to participate
Key inclusion criteria (3 listed)
- female sex
- a diagnosis of chronic kidney disease or end stage kidney disease
- age 18-51
Key exclusion criteria (1 listed)
- Pregnancy, breastfeeding, current use of menopausal hormone therapy or gender affirming hormone therapy, or factors that would affect ovarian function, such as polycystic ovarian syndrome, premature ovarian insufficiency, ovarian malignancy, gonadotoxic chemotherapy, surgical oophorectomy, or previous radiation to the pelvis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulse wave velocity
Time frame: Measured at baseline
Aortic augmentation index
Time frame: Measured at baseline
Flow mediated dilation
Time frame: Measured at baseline
Velocity time integral
Time frame: Measured at baseline
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 30 Oct 2023.
- 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.
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 Chronic Kidney Diseases and Cardiovascular Diseases, run by University of Calgary at 1 site in Canada.
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 1 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 30 Oct 2023. 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 Canada. 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?
Pulse wave velocity (time frame: Measured at baseline). The study lists 4 primary outcomes in all. 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 30 Oct 2023.