Chronic Kidney DiseaseCAPSICUMNCT07802665
Capillary Sampling in Clinical Populations Undergoing Monitoring
An observational study of Chronic Kidney Disease and Autoimmune Diseases, run by University of Edinburgh.
Trial summary
Many people with long-term health conditions require regular blood tests to monitor their disease or medications. These blood tests are usually performed by taking blood from a vein during a hospital or clinic appointment. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Chronic Kidney Disease, Autoimmune Diseases, Solid Organ Transplant Recipients
- What is being tested?
- Blood sampling with capillary sampling device(s)
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 2029
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A maximum of 1000 participants will be recruited. The study aims to include approximately 200 participants from each of five clinical populations in which regular blood monitoring forms part of routine care and where remote capillary blood sampling has the potential to improve access to monitoring or patient experience: * Patients with kidney disease * Patients with immune-mediated disease * Kidney, kidney-pancreas and islet transplant recipients * Patients with mental health disorders requiring regular blood monitoring * Children attending paediatric services who require regular blood monitoring
Who may be able to join
- Eligible participants are individuals who require routine venous blood sampling as part of their usual clinical care and who represent clinical populations in which remote capillary blood sampling may improve access to monitoring or patient experience.
- All participants must:
- Be attending a routine clinical appointment during which venous blood sampling is planned as part of standard clinical care for disease monitoring or therapeutic drug monitoring.
- Be willing and able to undertake capillary blood sampling independently or with appropriate assistance.
- Adult participants must:
- Be aged ≥18 years of age.
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- Have capacity to provide written informed consent.
- Paediatric participants must:
- Be aged 6-15 years of age.
- If aged 6-11, be attending with a parent or legal guardian able to provide written informed consent and provide age-appropriate assent where applicable.
- If aged 12-15: be attending with a parent or legal guardian able to provide written informed consent and provide age-appropriate assent where applicable OR if deemed to have capacity themselves, be able to provide written informed consent and be attending with a parent or legal guardian who agrees to their participation.
- Additional eligibility criteria
- Autoimmune disease group: participants must have a diagnosis of immune-mediated disease based on the assessment of their treating clinician.
- Transplant recipient group: participants must be the recipient of a functioning kidney, kidney-pancreas, or islet transplant.
- Mental health group: participants must have a diagnosis of a mental health disorder based on the assessment of their treating clinician.
- Paediatric group: participants must be attending a paediatric clinic and require blood sampling as part of standard clinical care.
Who cannot join
- Inability or unwillingness to provide informed consent, or, for paediatric participants, absence of parental or legal guardian consent or age-appropriate assent where applicable.
- Skin disease, infection, injury, or other local factors at the intended sampling site that would make capillary blood collection unsafe or impractical.
- Known allergy or hypersensitivity to any materials used in the capillary blood sampling devices.
- Inability to undertake the capillary sampling procedures independently or with appropriate assistance.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Many people with long-term health conditions require regular blood tests to monitor their disease or medications. These blood tests are usually performed by taking blood from a vein during a hospital or clinic appointment. This can be inconvenient, time-consuming and difficult for some people, particularly those who live far from hospital, have reduced mobility, require frequent tests, or experience anxiety about attending healthcare settings or having blood taken.
Capillary blood sampling devices allow people to collect a small blood sample themselves, usually from the upper arm or fingertip, which can then be sent to a laboratory by post. These devices have shown promising results for some blood tests, but there is insufficient evidence of which tests remain accurate when samples are collected at home, posted to the laboratory and subjected to postage conditions and delayed analysis.
Read more
The CAPSICUM study will compare blood samples collected using patient-operated capillary sampling devices with routine venous blood samples already being taken as part of participants' usual clinical care. We will investigate whether a wide range of blood tests produce similar results using both methods and assess how delayed analysis, postal transport and home collection affect test accuracy.
Participants will attend only one study visit, which will take place during a routine clinic appointment. Some participants will also be invited to collect an additional blood sample at home and return it by post, and to complete a brief questionnaire about their experience.
The findings from this study will help identify which blood tests can be safely monitored using home capillary blood sampling. This could improve access to blood monitoring, reduce unnecessary hospital visits, make monitoring more convenient for patients, and support the development of safe, evidence-based remote monitoring pathways within the NHS.
- Being tested
- Blood sampling with capillary sampling device(s)
- Medical subject headings
- Renal Insufficiency, Chronic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling with capillary sampling device(s)Diagnostic test
Blood sampling with capillary sampling device(s)
| Study group | Role | What they receive |
|---|---|---|
| Patients with kidney disease | Not described Receives: Diagnostic Test: Blood sampling with capillary sampling device(s) | |
| Patients with immune-mediated disease | e.g. ANCA-associated vasculitis or systemic lupus erythematosus Receives: Diagnostic Test: Blood sampling with capillary sampling device(s) | |
| Kidney, kidney-pancreas and islet transplant recipients | Not described Receives: Diagnostic Test: Blood sampling with capillary sampling device(s) | |
| Patients with mental health disorders who experience barriers to conventional blood sampling | Not described Receives: Diagnostic Test: Blood sampling with capillary sampling device(s) | |
| Children requiring regular blood monitoring | Not described Receives: Diagnostic Test: Blood sampling with capillary sampling device(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
For each pre-defined analyte, the mean difference and 95% limits of agreement between paired capillary and venous blood sample results under immediate analysis conditions, assessed against predefined clinically acceptable limits of agreement.
Measured: From enrollment to end of study visit 1
Secondary outcomes (6)
Mean difference and 95% limits of agreement following delayed analysis (24-48 hours).
Measured: From enrollment to end of study visit 1
Mean difference and 95% limits of agreement following delayed analysis after exposure to temperatures representative of routine postal transport.
Measured: Enrollment to end of study visit 1
Mean difference and 95% limits of agreement following unsupervised patient-led home collection and postal return.
Measured: Enrollment to end of study visit 1
Proportion of successful capillary sample collections and proportion of samples unsuitable for laboratory analysis, by analyte, patient group and sampling device.
Measured: Enrollment to end of study visit 1
Reasons for unsuccessful sample collection or laboratory rejection, where available
Measured: Enrollment to end of study visit 1
Participant acceptability, pain, ease of use and overall preference for capillary sampling compared with venepuncture, assessed using validated questionnaires.
Measured: Enrollment to end of study visit 1
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 start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802665
- Sponsor's protocol ID
- AC26132
- Acronym
- CAPSICUM
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capillary Sampling in Clinical Populations Undergoing Monitoring
- ClinicalTrials.gov ID
- NCT07802665
- Acronym / sponsor ID
- CAPSICUM / AC26132
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (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.
Many people with long-term health conditions require regular blood tests to monitor their disease or medications. These blood tests are usually performed by taking blood from a vein during a hospital or clinic appointment. This can be inconvenient, time-consuming and difficult for some people, particularly those who live far from hospital, have reduced mobility, require frequent tests, or experience anxiety about attending healthcare settings or having blood taken.
Capillary blood sampling devices allow people to collect a small blood sample themselves, usually from the upper arm or fingertip, which can then be sent to a laboratory by post. These devices have shown promising results for some blood tests, but there is insufficient evidence of which tests remain accurate when samples are collected at home, posted to the laboratory and subjected to postage conditions and delayed analysis.
The CAPSICUM study will compare blood samples collected using patient-operated capillary sampling devices with routine venous blood samples already being taken as part of participants' usual clinical care. We will investigate whether a wide range of blood tests produce similar results using both methods and assess how delayed analysis, postal transport and home collection affect test accuracy.
Participants will attend only one study visit, which will take place during a routine clinic appointment. Some participants will also be invited to collect an additional blood sample at home and return it by post, and to complete a brief questionnaire about their experience.
The findings from this study will help identify which blood tests can be safely monitored using home capillary blood sampling. This could improve access to blood monitoring, reduce unnecessary hospital visits, make monitoring more convenient for patients, and support the development of safe, evidence-based remote monitoring pathways within the NHS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with kidney disease | – | Diagnostic Test: Blood sampling with capillary sampling device(s) |
| Patients with immune-mediated disease | – | Diagnostic Test: Blood sampling with capillary sampling device(s)e.g. ANCA-associated vasculitis or systemic lupus erythematosus |
| Kidney, kidney-pancreas and islet transplant recipients | – | Diagnostic Test: Blood sampling with capillary sampling device(s) |
| Patients with mental health disorders who experience barriers to conventional blood sampling | – | Diagnostic Test: Blood sampling with capillary sampling device(s) |
| Children requiring regular blood monitoring | – | Diagnostic Test: Blood sampling with capillary sampling device(s) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A maximum of 1000 participants will be recruited. The study aims to include approximately 200 participants from each of five clinical populations in which regular blood monitoring forms part of routine care and where remote capillary blood sampling has the potential to improve access to monitoring or patient experience: * Patients with kidney disease * Patients with immune-mediated disease * Kidney, kidney-pancreas and islet transplant recipients * Patients with mental health disorders requiring regular blood monitoring * Children attending paediatric services who require regular blood monitoring
Key inclusion criteria (16 listed)
- Eligible participants are individuals who require routine venous blood sampling as part of their usual clinical care and who represent clinical populations in which remote capillary blood sampling may improve access to monitoring or patient experience.
- Be attending a routine clinical appointment during which venous blood sampling is planned as part of standard clinical care for disease monitoring or therapeutic drug monitoring.
- Be willing and able to undertake capillary blood sampling independently or with appropriate assistance.
- Be aged ≥18 years of age.
- Have capacity to provide written informed consent.
Key exclusion criteria (4 listed)
- Inability or unwillingness to provide informed consent, or, for paediatric participants, absence of parental or legal guardian consent or age-appropriate assent where applicable.
- Skin disease, infection, injury, or other local factors at the intended sampling site that would make capillary blood collection unsafe or impractical.
- Known allergy or hypersensitivity to any materials used in the capillary blood sampling devices.
- Inability to undertake the capillary sampling procedures independently or with appropriate assistance.
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 |
|---|---|---|
| Blood sampling with capillary sampling device(s)Blood sampling with capillary sampling device(s) | Diagnostic test | Children requiring regular blood monitoring, Kidney, kidney-pancreas and islet transplant recipients, Patients with immune-mediated disease, Patients with kidney disease, Patients with mental health disorders who experience barriers to conventional blood sampling |
Primary outcome
For each pre-defined analyte, the mean difference and 95% limits of agreement between paired capillary and venous blood sample results under immediate analysis conditions, assessed against predefined clinically acceptable limits of agreement.
Time frame: From enrollment to end of study visit 1
6 secondary outcomes
Mean difference and 95% limits of agreement following delayed analysis (24-48 hours).
Time frame: From enrollment to end of study visit 1
Mean difference and 95% limits of agreement following delayed analysis after exposure to temperatures representative of routine postal transport.
Time frame: Enrollment to end of study visit 1
Mean difference and 95% limits of agreement following unsupervised patient-led home collection and postal return.
Time frame: Enrollment to end of study visit 1
Proportion of successful capillary sample collections and proportion of samples unsuitable for laboratory analysis, by analyte, patient group and sampling device.
Time frame: Enrollment to end of study visit 1
Reasons for unsuccessful sample collection or laboratory rejection, where available
Time frame: Enrollment to end of study visit 1
Participant acceptability, pain, ease of use and overall preference for capillary sampling compared with venepuncture, assessed using validated questionnaires.
Time frame: Enrollment to end of study visit 1
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.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Autoimmune Diseases, run by University of Edinburgh.
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 16 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.
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 Richard Shemilt, MBChB (+441312427978, rshemilt@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For each pre-defined analyte, the mean difference and 95% limits of agreement between paired capillary and venous blood sample results under immediate analysis conditions, assessed against predefined clinically acceptable limits of agreement. (time frame: From enrollment to end of study visit 1). 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 3 Sep 2026.