Chronic Kidney DiseaseNCT07801937
Family TIME: A Family-focused Nursing Intervention for Adults Receiving Haemodialysis and Their Families
A study testing Family TIME in people with Chronic Kidney Disease and Hemodialysis, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to evaluate whether a structured family conversation intervention can be delivered in a feasible and acceptable way to adults living with chronic kidney disease (CKD) and their family members. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hemodialysis
- What is being tested?
- Family TIME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Aug 2026to 31 May 2027
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient aged 18 years or older
- Currently receiving in-centre haemodialysis for CKD
- Has received in-centre haemodialysis for at least 3 months
- Able to read, speak, and understand Danish
- Able to provide written informed consent
- Able to identify at least one family member willing to participate
Show all 9Show fewer
- Participating family member aged 18 years or older
- Participating family member able to speak and understand Danish
- Participating family member able to provide written informed consent
Who cannot join
- Documented cognitive impairment preventing informed consent or participation
- Clinically assessed as too physically or psychologically unwell to participate
- Unable to participate in Danish
- Currently receiving structured family therapy or another family-focused psychosocial intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Odense University Hospital
Odense
Hanne Agerskov, Professor, +45 2942 7086, Hanne.Agerskov@rsyd.dk
About this study
Official title: Family TIME: Protocol for a Randomised Mixed-methods Feasibility Study of a Family-focused Nursing Intervention for Adults Receiving Haemodialysis and Their Families
The goal of this clinical trial is to evaluate whether a structured family conversation intervention can be delivered in a feasible and acceptable way to adults living with chronic kidney disease (CKD) and their family members. The study will also explore whether the intervention and study procedures are suitable for a future larger clinical trial.
The main questions it aims to answer are:
Read more
Can adults with CKD and their family members be successfully recruited, enrolled, and retained throughout the study? Is the Family Time intervention acceptable and practical for patients, family members, and healthcare professionals? Are the study procedures and selected questionnaires appropriate for evaluating a future larger trial? Does the intervention show potential to support family functioning and well-being?
Researchers will compare the Family Time intervention plus usual care with usual care alone.
Participants will:
Complete questionnaires before and after the study period. Be allocated to either the Family Time intervention or usual care. If allocated to the intervention group, participate in three structured family conversations over approximately 8 weeks, with the option of one additional follow-up conversation.
If allocated to the intervention group, be invited to take part in an interview about their experiences after completing the intervention.
Read the detailed description
Adults living with chronic kidney disease (CKD) experience substantial physical, emotional, and social challenges that extend beyond the individual and influence everyday family life. Family members frequently take on important supportive roles while simultaneously experiencing changes in family routines, responsibilities, communication, and well-being. Although family involvement is recognised as an important component of person-centred CKD care, structured family-focused interventions remain limited, and evidence supporting their implementation in routine nephrology practice is scarce.
This study aims to evaluate the feasibility and acceptability of Family Time, a nurse-led family-focused intervention developed to support communication, shared understanding, and relational well-being among adults living with CKD and their families. The intervention has been developed following the Medical Research Council (MRC) framework for developing and evaluating complex interventions and informed by evidence synthesis, qualitative research, stakeholder workshops, and patient and family involvement.
A mixed-methods randomised feasibility trial will be conducted at two in-centre haemodialysis units in Denmark. Adults receiving in-centre haemodialysis and at least one participating family member will be allocated to either the Family Time intervention plus usual care or usual care alone. The intervention consists of three structured family conversations delivered over approximately 8 weeks, with the option of one additional follow-up conversation. Sessions are facilitated by the principal investigator and may be delivered face-to-face, online, or by telephone according to family preferences and practical circumstances.
The primary outcomes are feasibility and acceptability of the intervention and study procedures, including recruitment, retention, intervention delivery, questionnaire completion, and participant experiences. Secondary exploratory outcomes include family functioning, individual well-being, and family communication, assessed using the Iceland Expressive Family Functioning Questionnaire (ICE-EFFQ), the WHO-5 Well-Being Index, and post-intervention qualitative interviews.
The findings will inform refinement of both the intervention and study procedures and determine whether progression to a future definitive randomised controlled trial is warranted.
- Conditions
- Chronic Kidney Disease, Hemodialysis
- Being tested
- Family TIME
- Keywords
- Chronic Kidney Disease, Hemodialysis, Family, Family conversations, Family intervention, Family functioning
- 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.
Family TIMEOther
Participants allocated to the intervention group will receive the Family Time intervention in addition to usual care. The intervention consists of three structured family conversations delivered over approximately 8 weeks, with the option of one additional follow-up session. Conversations are facilitated by the principal investigator and may be delivered face-to-face, online, or by telephone according to family preferences and practical circumstances.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants allocated to the control group will receive usual care provided by the participating haemodialysis units throughout the study period. |
| Family Time + Usual Care | Experimental | Participants allocated to the intervention group will receive the Family Time intervention in addition to usual care. Receives: Other: Family TIME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number and proportion of eligible family units recruited into the study.
Measured: From the first family conversation to completion of the intervention, up to 8 weeks.
Retention rate
Number and proportion of participants completing follow-up.
Measured: 8 weeks after baseline
Intervention delivery
Number and proportion of planned structured facilitated family conversations completed according to protocol.
Measured: From the first family conversation through completion of the intervention, up to 8 weeks.
Intervention acceptability
Acceptability assessed using the Danish version of the Acceptability of Intervention Measure (AIM).
Measured: 8 weeks after baseline
Study procedures
Questionnaire completion rate, follow-up completion and completeness of data collection procedures.
Measured: Baseline and Week 9
Implementation considerations
Barriers and facilitators identified through intervention logs, facilitator field notes and qualitative interviews.
Measured: Throughout the 8-week intervention period and at post-intervention interview in Week 9
Secondary outcomes (2)
Family functioning
Family functioning will be assessed using the Iceland Expressive Family Functioning Questionnaire (ICE-EFFQ), a 17-item questionnaire assessing expressive family functioning, including communication, emotional expression, collaboration and family relationships. Total scores range from 17 to 85, with higher scores indicating more positive expressive family functioning.
Measured: Baseline and 8 weeks after baseline.
Individual well-being
Subjective well-being will be assessed using the World Health Organization Five Well-Being Index (WHO-5). Raw scores range from 0 to 25 and are transformed to a scale from 0 to 100, with higher scores indicating greater subjective well-being.
Measured: Baseline and 8 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start10 Aug 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Griffith University
- Responsible party
- Sponsor
- Investigators
- Hanne Agerskov, Professor, Study director, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801937
- Sponsor's protocol ID
- Family TIME
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request, subject to approval by the study investigators, applicable ethical approvals, institutional policies, and Danish data protection regulations.
Publications
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Sveinbjarnardottir EK, Svavarsdottir EK, Hrafnkelsson B. Psychometric development of the Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ). J Fam Nurs. 2012 Aug;18(3):353-77. doi: 10.1177/1074840712449204. Epub 2012 Jun 29.
PubMed 22752795Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
PubMed 27777223Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
PubMed 26978655Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. Int J Nurs Stud. 2024 Jun;154:104705. doi: 10.1016/j.ijnurstu.2024.104705. Epub 2024 Feb 24.
PubMed 38564982Gillespie KM, Purtell L, Finderup J, Schjerning N, Bonner A. Interventions to Reduce Burden Among Informal Caregivers of People With Chronic Kidney Disease: Systematic Review and Meta-Analysis. J Ren Care. 2026 Jun;52(2):e70063. doi: 10.1111/jorc.70063.
PubMed 42159051Azcarate-Cenoz N, Canga-Armayor A, Alfaro-Diaz C, Canga-Armayor N, Pueyo-Garrigues M, Esandi N. Family-Oriented Therapeutic Conversations: A Systematic Scoping Review. J Fam Nurs. 2024 May;30(2):145-173. doi: 10.1177/10748407241235141. Epub 2024 Mar 26.
PubMed 38529615Araujo H, Marques E, Lourenco I, Bonifacio C, Gomes F. Nursing Interventions to Support Family Caregivers of Patients on Haemodialysis: A Mixed-Methods Systematic Review. J Adv Nurs. 2026 Jun;82(6):5813-5834. doi: 10.1111/jan.70297. Epub 2025 Oct 29.
PubMed 41159560Sousa H, Ribeiro O, Figueiredo D. Purpose in life among haemodialysis caregivers: Links with adaptive coping, caregiver burden, and psychological distress. Stress Health. 2024 Oct;40(5):e3460. doi: 10.1002/smi.3460. Epub 2024 Aug 12.
PubMed 39134404Yapa HE, Purtell L, Chambers S, Bonner A. The Relationship Between Chronic Kidney Disease, Symptoms and Health-Related Quality of Life: A Systematic Review. J Ren Care. 2020 Jun;46(2):74-84. doi: 10.1111/jorc.12303. Epub 2019 Nov 3.
PubMed 31680483
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family TIME: Protocol for a Randomised Mixed-methods Feasibility Study of a Family-focused Nursing Intervention for Adults Receiving Haemodialysis and Their Families
- ClinicalTrials.gov ID
- NCT07801937
- Acronym / sponsor ID
- Family TIME
- Conditions
- Chronic Kidney Disease, Hemodialysis
- Keywords
- Chronic Kidney Disease, Hemodialysis, Family, Family conversations, Family intervention, Family functioning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Griffith University
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Sep 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.
The goal of this clinical trial is to evaluate whether a structured family conversation intervention can be delivered in a feasible and acceptable way to adults living with chronic kidney disease (CKD) and their family members. The study will also explore whether the intervention and study procedures are suitable for a future larger clinical trial.
The main questions it aims to answer are:
Can adults with CKD and their family members be successfully recruited, enrolled, and retained throughout the study? Is the Family Time intervention acceptable and practical for patients, family members, and healthcare professionals? Are the study procedures and selected questionnaires appropriate for evaluating a future larger trial? Does the intervention show potential to support family functioning and well-being?
Researchers will compare the Family Time intervention plus usual care with usual care alone.
Participants will:
Complete questionnaires before and after the study period. Be allocated to either the Family Time intervention or usual care. If allocated to the intervention group, participate in three structured family conversations over approximately 8 weeks, with the option of one additional follow-up conversation.
If allocated to the intervention group, be invited to take part in an interview about their experiences after completing the intervention.
Detailed description
Adults living with chronic kidney disease (CKD) experience substantial physical, emotional, and social challenges that extend beyond the individual and influence everyday family life. Family members frequently take on important supportive roles while simultaneously experiencing changes in family routines, responsibilities, communication, and well-being. Although family involvement is recognised as an important component of person-centred CKD care, structured family-focused interventions remain limited, and evidence supporting their implementation in routine nephrology practice is scarce.
This study aims to evaluate the feasibility and acceptability of Family Time, a nurse-led family-focused intervention developed to support communication, shared understanding, and relational well-being among adults living with CKD and their families. The intervention has been developed following the Medical Research Council (MRC) framework for developing and evaluating complex interventions and informed by evidence synthesis, qualitative research, stakeholder workshops, and patient and family involvement.
A mixed-methods randomised feasibility trial will be conducted at two in-centre haemodialysis units in Denmark. Adults receiving in-centre haemodialysis and at least one participating family member will be allocated to either the Family Time intervention plus usual care or usual care alone. The intervention consists of three structured family conversations delivered over approximately 8 weeks, with the option of one additional follow-up conversation. Sessions are facilitated by the principal investigator and may be delivered face-to-face, online, or by telephone according to family preferences and practical circumstances.
The primary outcomes are feasibility and acceptability of the intervention and study procedures, including recruitment, retention, intervention delivery, questionnaire completion, and participant experiences. Secondary exploratory outcomes include family functioning, individual well-being, and family communication, assessed using the Iceland Expressive Family Functioning Questionnaire (ICE-EFFQ), the WHO-5 Well-Being Index, and post-intervention qualitative interviews.
The findings will inform refinement of both the intervention and study procedures and determine whether progression to a future definitive randomised controlled trial is warranted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants allocated to the control group will receive usual care provided by the participating haemodialysis units throughout the study period. |
| Family Time + Usual Care | Experimental | Other: Family TIMEParticipants allocated to the intervention group will receive the Family Time intervention in addition to usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patient aged 18 years or older
- Currently receiving in-centre haemodialysis for CKD
- Has received in-centre haemodialysis for at least 3 months
- Able to read, speak, and understand Danish
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- Documented cognitive impairment preventing informed consent or participation
- Clinically assessed as too physically or psychologically unwell to participate
- Unable to participate in Danish
- Currently receiving structured family therapy or another family-focused psychosocial intervention
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 |
|---|---|---|
| Family TIMEParticipants allocated to the intervention group will receive the Family Time intervention in addition to usual care. The intervention consists of three structured family conversations delivered over approximately 8 weeks, with the option of one additional follow-up session. Conversations are facilitated by the principal investigator and may be delivered face-to-face, online, or by telephone according to family preferences and practical circumstances. | Other | Family Time + Usual Care |
Primary outcome
Recruitment rate
Time frame: From the first family conversation to completion of the intervention, up to 8 weeks.
Number and proportion of eligible family units recruited into the study.
Retention rate
Time frame: 8 weeks after baseline
Number and proportion of participants completing follow-up.
Intervention delivery
Time frame: From the first family conversation through completion of the intervention, up to 8 weeks.
Number and proportion of planned structured facilitated family conversations completed according to protocol.
Intervention acceptability
Time frame: 8 weeks after baseline
Acceptability assessed using the Danish version of the Acceptability of Intervention Measure (AIM).
Study procedures
Time frame: Baseline and Week 9
Questionnaire completion rate, follow-up completion and completeness of data collection procedures.
Implementation considerations
Time frame: Throughout the 8-week intervention period and at post-intervention interview in Week 9
Barriers and facilitators identified through intervention logs, facilitator field notes and qualitative interviews.
2 secondary outcomes
Family functioning
Time frame: Baseline and 8 weeks after baseline.
Individual well-being
Time frame: Baseline and 8 weeks after baseline.
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 3 Sep 2026.
- Background: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Background: PubMed 22752795Sveinbjarnardottir EK, Svavarsdottir EK, Hrafnkelsson B. Psychometric development of the Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ). J Fam Nurs. 2012 Aug;18(3):353-77. doi: 10.1177/1074840712449204. Epub 2012 Jun 29.
- Background: PubMed 27777223Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
- Background: PubMed 26978655Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
- Background: PubMed 38564982Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. Int J Nurs Stud. 2024 Jun;154:104705. doi: 10.1016/j.ijnurstu.2024.104705. Epub 2024 Feb 24.
- Background: PubMed 42159051Gillespie KM, Purtell L, Finderup J, Schjerning N, Bonner A. Interventions to Reduce Burden Among Informal Caregivers of People With Chronic Kidney Disease: Systematic Review and Meta-Analysis. J Ren Care. 2026 Jun;52(2):e70063. doi: 10.1111/jorc.70063.
- Background: PubMed 38529615Azcarate-Cenoz N, Canga-Armayor A, Alfaro-Diaz C, Canga-Armayor N, Pueyo-Garrigues M, Esandi N. Family-Oriented Therapeutic Conversations: A Systematic Scoping Review. J Fam Nurs. 2024 May;30(2):145-173. doi: 10.1177/10748407241235141. Epub 2024 Mar 26.
- Background: PubMed 41159560Araujo H, Marques E, Lourenco I, Bonifacio C, Gomes F. Nursing Interventions to Support Family Caregivers of Patients on Haemodialysis: A Mixed-Methods Systematic Review. J Adv Nurs. 2026 Jun;82(6):5813-5834. doi: 10.1111/jan.70297. Epub 2025 Oct 29.
- Background: PubMed 39134404Sousa H, Ribeiro O, Figueiredo D. Purpose in life among haemodialysis caregivers: Links with adaptive coping, caregiver burden, and psychological distress. Stress Health. 2024 Oct;40(5):e3460. doi: 10.1002/smi.3460. Epub 2024 Aug 12.
- Background: PubMed 31680483Yapa HE, Purtell L, Chambers S, Bonner A. The Relationship Between Chronic Kidney Disease, Symptoms and Health-Related Quality of Life: A Systematic Review. J Ren Care. 2020 Jun;46(2):74-84. doi: 10.1111/jorc.12303. Epub 2019 Nov 3.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request, subject to approval by the study investigators, applicable ethical approvals, institutional policies, and Danish data protection regulations.
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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.
Hanne Agerskov, Professor study director
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family TIME in people with Chronic Kidney Disease and Hemodialysis, run by University of Southern Denmark at 1 site in Denmark.
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 9 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Sep 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 Denmark. 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 Jeannett A Klitgaard, Master of Science in Nursing (+4540478192, jekl@ucl.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From the first family conversation to completion of the intervention, up to 8 weeks.). The study lists 6 primary outcomes in all. 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 NCT07801937, which also lists 10 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 3 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.