Renal Insufficiency, ChronicIMAJENCT07690202
Living With Chronic Kidney Disease Without Renal Replacement Therapy: Experience of Women of Childbearing Age
An observational study of Renal Insufficiency, Chronic, run by University Hospital, Caen at 1 site in France.
Trial summary
Chronic kidney disease (CKD) affects approximately 13% of the global population. This condition is often associated with comorbidities such as diabetes and hypertension. Although its prevalence increases with age, CKD can also affect younger individuals, particularly women of childbearing age. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Renal Insufficiency, Chronic
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women of childbearing age with chronic kidney disease (CKD) not receiving renal replacement therapy (i.e., not on dialysis or kidney transplantation), followed at Caen University Hospital (CHU de Caen). Participants will be divided into two groups according to CKD etiology: genetic and non-genetic.
Who may be able to join
- Women aged ≥ 18 years, cisgender, and not menopausal
- Patients under follow-up at Caen University Hospital for chronic kidney disease
- Patients not receiving renal replacement therapy (i.e., not on dialysis or kidney transplantation)
- Patients who have been informed about the study and provided consent to participate
Who cannot join
- Patients not covered by a national health insurance system
- Patients under legal protection (guardianship, curatorship, or legal safeguard)
- Patients with insufficient proficiency in French (spoken and written) to understand study information, participate in the interview, and complete the quality-of-life questionnaire
- Patients unable to attend in-person visits at the Centre Universitaire des Maladies Rénales (CUMR)
- Patients with comorbid conditions other than chronic kidney disease that may interfere with the study objectives (e.g. conditions affecting fertility)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Universitaire des Maladies Rénales (CUMR), Caen University Hospital
Caen, 14000
Antoine Lanot, MD, +33231272343, lanot-a@chu-caen.fr
About this study
Chronic kidney disease (CKD) affects approximately 13% of the global population. This condition is often associated with comorbidities such as diabetes and hypertension. Although its prevalence increases with age, CKD can also affect younger individuals, particularly women of childbearing age. From the early stages, CKD may lead to female-specific clinical manifestations, such as reduced fertility, occurring at a key period of life. These clinical aspects may also be accompanied by concerns about the transmission of hereditary nephropathy and may generate a significant psychological burden. However, current knowledge regarding the lived experience of young women of childbearing age with CKD remains limited, particularly in France.
The main objective of this study is to explore the lived experience of young women with CKD who are not receiving kidney replacement therapy. In this study, lived experience refers to how participants perceive, make sense of, and integrate CKD into their daily lives and future life plans. Twelve participants with CKD, not transplanted and not on dialysis, will be recruited and divided into two groups: six women with genetically determined CKD and six women with non-genetic CKD. This grouping is justified by the fact that the etiology of the disease may profoundly influence lived experience. Genetic CKD is often associated with concerns regarding familial transmission and early medical follow-up, whereas non-genetic CKD may be perceived as an acquired condition occurring later in life. Data will be collected through semi-structured interviews based on a tailored interview guide. Transcripts will be analysed using Interpretative Phenomenological Analysis (IPA), which allows exploration of the meaning that each participant attributes to her experience.
This is an exploratory pilot study aiming to document, for the first time in France, the lived experience of young women with CKD, with a secondary focus on the potential impact of genetic versus non-genetic etiology. Particular attention will be given to themes related to sexual and reproductive health. The findings will contribute to a better understanding of this understudied population and may ultimately improve their clinical care.
Read the detailed description
This study is a qualitative study using Interpretative Phenomenological Analysis (IPA) based on semi-structured interviews. IPA is particularly well suited to exploring the meaning individuals attribute to their lived experiences. The choice of this methodology is justified by the nature of the research question. Exploring the lived experience of patients with a chronic illness requires consideration of a wide range of issues, including identity-related, relational, and emotional dimensions, which go beyond the strictly biomedical aspects usually addressed. Compared with more descriptive qualitative approaches, such as thematic analysis, IPA provides deeper access to the complexity of subjective experience, namely the personal meaning given to illness and the way it is integrated into daily life and future life projects. It is therefore particularly appropriate for highlighting the lived experience of a condition often described as "invisible".
This psychological approach is grounded in a phenomenological perspective, as it explores how participants perceive and experience illness, rather than providing an objective description of symptoms or medical trajectories. It is also based on the principle of double hermeneutics: the researcher seeks to make sense of the participant's account, while the participant seeks to make sense of her own experience. Finally, IPA is idiographic, as it prioritises an in-depth analysis of individual cases before any attempt at generalisation or comparison. The analysis will be conducted on small samples to allow for a detailed and in-depth examination of each case. The sample will therefore consist of 12 participants (two groups of six participants). Participants will be at least 18 years of age and premenopausal.
Data will be collected through semi-structured interviews based on a tailored interview guide. The first part of the interview will be dedicated to a free narrative. The discussion will therefore evolve according to the participant's responses, allowing the researcher to explore the themes that emerge as priorities for the participant. The second part will consist of a more guided exploration, in which topics identified in the literature as relevant will be introduced to allow further discussion. The interview guide will be developed in collaboration with a psychologist. Prior to data collection, it will be tested with an expert patient who is a member of a patient association for individuals with kidney disease, in order to assess the relevance of the questions and adjust them if necessary. This patient will not be included in the study sample. In line with the IPA approach, the interview guide may be modified and refined throughout the study to accommodate emerging themes.
In addition to the interviews, participants will complete the KDQOL-36 questionnaire (Kidney Disease Quality of Life-36). This is a widely used standardized instrument for assessing quality of life in patients with chronic kidney disease. Responses are collected using Likert-type scales, allowing the calculation of domain-specific scores and an overall quality-of-life score. The questionnaire will be administered after the interview in order to avoid influencing participants' narratives and the IPA analysis. The resulting scores will be used for descriptive purposes only and will help situate each participant's overall experience of the disease, thereby enriching the contextual understanding of each interview.
Finally, a comparison between themes emerging from the interviews and the dimensions assessed by the KDQOL-36 will make it possible to identify aspects of lived experience that are potentially not captured or insufficiently addressed by the instrument, but which are nevertheless meaningful for participants.
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Chronic kidney disease, Women of childbearing age, Lived experience, Interpretative Phenomenological Analysis (IPA)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Genetic CKD group | Women of childbearing age diagnosed with chronic kidney disease (CKD) of confirmed or suspected genetic etiology, not receiving renal replacement therapy (i.e., not on dialysis orkidney transplantation). | |
| Non-genetic CKD group | Women of childbearing age diagnosed with chronic kidney disease (CKD) of non-genetic etiology, not receiving renal replacement therapy (i.e., not on dialysis or kidney transplantation). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lived experience of chronic kidney disease in women of childbearing age (without renal replacement therapy)
Exploration of participants' lived experience of CKD, including perceptions of the disease, impact on daily life, and influence on future life plans, collected through semi-structured interviews and analysed using Interpretative Phenomenological Analysis (IPA).
Measured: Baseline (single study visit)
Secondary outcomes (3)
Impact of chronic kidney disease etiology (genetic vs non-genetic) on lived experience
Exploratory comparison of lived experiences between participants with chronic kidney disease of genetic and non-genetic etiology.
Measured: Baseline (single interview)
Emergent themes related to sexual and reproductive health
Identification of emerging themes related to sexual and reproductive health during semi-structured interviews.
Measured: Baseline (single interview)
Health-related quality of life (KDQOL-36)
Assessment of health-related quality of life using the KDQOL-36 questionnaire, providing domain-specific and overall quality-of-life scores.
Measured: Baseline (single interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start30 Jun 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Lanot, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690202
- Sponsor's protocol ID
- 25-0354
- Acronym
- IMAJE
- Status last verified
- May 2026
- First submitted
- 1 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the sensitive and potentially identifiable nature of qualitative interview data. Participants' confidentiality will be ensured in accordance with ethical and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With Chronic Kidney Disease Without Renal Replacement Therapy: Experience of Women of Childbearing Age
- ClinicalTrials.gov ID
- NCT07690202
- Acronym / sponsor ID
- IMAJE / 25-0354
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Chronic kidney disease, Women of childbearing age, Lived experience, Interpretative Phenomenological Analysis (IPA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Jul 2026 (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.
Chronic kidney disease (CKD) affects approximately 13% of the global population. This condition is often associated with comorbidities such as diabetes and hypertension. Although its prevalence increases with age, CKD can also affect younger individuals, particularly women of childbearing age. From the early stages, CKD may lead to female-specific clinical manifestations, such as reduced fertility, occurring at a key period of life. These clinical aspects may also be accompanied by concerns about the transmission of hereditary nephropathy and may generate a significant psychological burden. However, current knowledge regarding the lived experience of young women of childbearing age with CKD remains limited, particularly in France.
The main objective of this study is to explore the lived experience of young women with CKD who are not receiving kidney replacement therapy. In this study, lived experience refers to how participants perceive, make sense of, and integrate CKD into their daily lives and future life plans. Twelve participants with CKD, not transplanted and not on dialysis, will be recruited and divided into two groups: six women with genetically determined CKD and six women with non-genetic CKD. This grouping is justified by the fact that the etiology of the disease may profoundly influence lived experience. Genetic CKD is often associated with concerns regarding familial transmission and early medical follow-up, whereas non-genetic CKD may be perceived as an acquired condition occurring later in life. Data will be collected through semi-structured interviews based on a tailored interview guide. Transcripts will be analysed using Interpretative Phenomenological Analysis (IPA), which allows exploration of the meaning that each participant attributes to her experience.
This is an exploratory pilot study aiming to document, for the first time in France, the lived experience of young women with CKD, with a secondary focus on the potential impact of genetic versus non-genetic etiology. Particular attention will be given to themes related to sexual and reproductive health. The findings will contribute to a better understanding of this understudied population and may ultimately improve their clinical care.
Detailed description
This study is a qualitative study using Interpretative Phenomenological Analysis (IPA) based on semi-structured interviews. IPA is particularly well suited to exploring the meaning individuals attribute to their lived experiences. The choice of this methodology is justified by the nature of the research question. Exploring the lived experience of patients with a chronic illness requires consideration of a wide range of issues, including identity-related, relational, and emotional dimensions, which go beyond the strictly biomedical aspects usually addressed. Compared with more descriptive qualitative approaches, such as thematic analysis, IPA provides deeper access to the complexity of subjective experience, namely the personal meaning given to illness and the way it is integrated into daily life and future life projects. It is therefore particularly appropriate for highlighting the lived experience of a condition often described as "invisible".
This psychological approach is grounded in a phenomenological perspective, as it explores how participants perceive and experience illness, rather than providing an objective description of symptoms or medical trajectories. It is also based on the principle of double hermeneutics: the researcher seeks to make sense of the participant's account, while the participant seeks to make sense of her own experience. Finally, IPA is idiographic, as it prioritises an in-depth analysis of individual cases before any attempt at generalisation or comparison. The analysis will be conducted on small samples to allow for a detailed and in-depth examination of each case. The sample will therefore consist of 12 participants (two groups of six participants). Participants will be at least 18 years of age and premenopausal.
Data will be collected through semi-structured interviews based on a tailored interview guide. The first part of the interview will be dedicated to a free narrative. The discussion will therefore evolve according to the participant's responses, allowing the researcher to explore the themes that emerge as priorities for the participant. The second part will consist of a more guided exploration, in which topics identified in the literature as relevant will be introduced to allow further discussion. The interview guide will be developed in collaboration with a psychologist. Prior to data collection, it will be tested with an expert patient who is a member of a patient association for individuals with kidney disease, in order to assess the relevance of the questions and adjust them if necessary. This patient will not be included in the study sample. In line with the IPA approach, the interview guide may be modified and refined throughout the study to accommodate emerging themes.
In addition to the interviews, participants will complete the KDQOL-36 questionnaire (Kidney Disease Quality of Life-36). This is a widely used standardized instrument for assessing quality of life in patients with chronic kidney disease. Responses are collected using Likert-type scales, allowing the calculation of domain-specific scores and an overall quality-of-life score. The questionnaire will be administered after the interview in order to avoid influencing participants' narratives and the IPA analysis. The resulting scores will be used for descriptive purposes only and will help situate each participant's overall experience of the disease, thereby enriching the contextual understanding of each interview.
Finally, a comparison between themes emerging from the interviews and the dimensions assessed by the KDQOL-36 will make it possible to identify aspects of lived experience that are potentially not captured or insufficiently addressed by the instrument, but which are nevertheless meaningful for participants.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetic CKD group | – | –Women of childbearing age diagnosed with chronic kidney disease (CKD) of confirmed or suspected genetic etiology, not receiving renal replacement therapy (i.e., not on dialysis orkidney transplantation). |
| Non-genetic CKD group | – | –Women of childbearing age diagnosed with chronic kidney disease (CKD) of non-genetic etiology, not receiving renal replacement therapy (i.e., not on dialysis or kidney transplantation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women of childbearing age with chronic kidney disease (CKD) not receiving renal replacement therapy (i.e., not on dialysis or kidney transplantation), followed at Caen University Hospital (CHU de Caen). Participants will be divided into two groups according to CKD etiology: genetic and non-genetic.
Key inclusion criteria (4 listed)
- Women aged ≥ 18 years, cisgender, and not menopausal
- Patients under follow-up at Caen University Hospital for chronic kidney disease
- Patients not receiving renal replacement therapy (i.e., not on dialysis or kidney transplantation)
- Patients who have been informed about the study and provided consent to participate
Key exclusion criteria (5 listed)
- Patients not covered by a national health insurance system
- Patients under legal protection (guardianship, curatorship, or legal safeguard)
- Patients with insufficient proficiency in French (spoken and written) to understand study information, participate in the interview, and complete the quality-of-life questionnaire
- Patients unable to attend in-person visits at the Centre Universitaire des Maladies Rénales (CUMR)
- Patients with comorbid conditions other than chronic kidney disease that may interfere with the study objectives (e.g. conditions affecting fertility)
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
Lived experience of chronic kidney disease in women of childbearing age (without renal replacement therapy)
Time frame: Baseline (single study visit)
Exploration of participants' lived experience of CKD, including perceptions of the disease, impact on daily life, and influence on future life plans, collected through semi-structured interviews and analysed using Interpretative Phenomenological Analysis (IPA).
3 secondary outcomes
Impact of chronic kidney disease etiology (genetic vs non-genetic) on lived experience
Time frame: Baseline (single interview)
Emergent themes related to sexual and reproductive health
Time frame: Baseline (single interview)
Health-related quality of life (KDQOL-36)
Time frame: Baseline (single interview)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the sensitive and potentially identifiable nature of qualitative interview data. Participants' confidentiality will be ensured in accordance with ethical and regulatory requirements.
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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.
Antoine Lanot, MD principal investigator
University Hospital, Caen
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 Renal Insufficiency, Chronic, run by University Hospital, Caen at 1 site in France.
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 4 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tauc Florence, PharmD candidate (+33682753772, florence.tauc@etu.unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lived experience of chronic kidney disease in women of childbearing age (without renal replacement therapy) (time frame: Baseline (single study visit)). 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 Jul 2026.