Kidney Transplant Failure and RejectionHBM-KTxNCT04369612
Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples
A study testing Standard follow-up and Home-based monitoring in people with Kidney Transplant Failure and Rejection, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Renal transplant recipients are followed as out patients at the transplant center for about 8 weeks after surgery. Between 1-2 weeks after surgery, 50 standard immunological patients will be randomized (1:1) to either follow standard of care (SOC) or having every second poli clinical visit without entering the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure and Rejection
- What is being tested?
- Standard follow-up and Home-based monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 28 Apr 2020to 31 Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney only transplant
- Immunosuppressive therapy With at least one of; tacrolimus, cyclosporine, everolimus, sirolimus, mycophenolate
- Standard immunological risk; no DSA, no PRA, not ABO-incompatible transplant
- Age above 18 years
- Followed at Oslo University Hospital-Rikshospitalet transplant center
- Written informed consent
Who cannot join
- Pregnant or breast feeding female recipients
- Ongoing acute rejection episodes at time of inclusion
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo Univeristy Hospital - Rikshospitralet
Oslo, 0424
Karsten Midtvedt, MD, PhD, 0047 23 07 1894, kmidtved@ous-hf.no
About this study
Renal transplant recipients are followed as out patients at the transplant center for about 8 weeks after surgery. Between 1-2 weeks after surgery, 50 standard immunological patients will be randomized (1:1) to either follow standard of care (SOC) or having every second poli clinical visit without entering the hospital HBM; Home Based Monitoring). They are to take a capillary finger-prick blood sample themselves, send it to the laboratory for analysis and then they will get a telecom follow-up that day from their transplant physician. Outcome is no difference with regards to being able to follow the randomized follow-up procedure.
Read the detailed description
Renal transplant recipients are followed as out patients at the transplant center for about 8 weeks after surgery. Between 1-2 weeks after surgery, 50 standard immunological patients (i.e. first, kidney (only) transplants, no donors specific antibodies (DSA), panel reactive antibodies (PRA), ABO blood type compatible transplant) will be randomized (1:1) to either follow standard of care (SOC) or having every second poli clinical visit without entering the hospital HBM; Home Based Monitoring). They are to take a capillary finger-prick blood sample themselves and send it to the laboratory for analysis (creatinine, hemoglobin, tacrolimus and mycophenolate) and then they will get a telecom follow-up that day from their transplant physician. Outcome is no difference with regards to being able to follow the randomized follow-up procedure without having acute rejection episodes and no need for extra ou-patients visits for any reason. End of study is week 7-8 after transplantation.
- Conditions
- Kidney Transplant Failure and Rejection
- Being tested
- Standard follow-up, Home-based monitoring
- Keywords
- capillary sample, finger-prick, home-based monitoring
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard follow-upProcedure or surgery
Standard post-transplant follow-up
Home-based monitoringProcedure or surgery
Patients take capillary blood sample by finger-prick and send to lab for analyses. Telecom follow-up that day by treating physician
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Standard follow-up after kidney transplantation during the first 7-8 post-transplant weeks Receives: Procedure: Standard follow-up |
| Home-based monitoring | Experimental | Every second visit will be performed without patients actually visiting the hospital. They take a capillary blood sample themselves, send it to the lab and get a telecom follow-up by treating physician the same day. Receives: Procedure: Home-based monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Complete follow-up without acute rejection and no need for extra visit of any cause
Measured: 1-8 weeks post-transplant
Secondary outcomes (1)
Extra visits to Control immunosuppressive drug levels
Number of extra visits in order to monitoring appropriate drug Levels of immunosuppressive drugs
Measured: 1-8 weeks post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start28 Apr 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two Groups, randomized 1:1, to a) Standard of care and b) home-based monitoring. Followed between 1-2 to 7-8 weeks after transplantation
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Åsberg, Oslo University Hospital
- Investigators
- Karsten Midtvedt, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369612
- Sponsor's protocol ID
- 134787
- Acronym
- HBM-KTx
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2020
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed without specific ethical committee approval
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples
- ClinicalTrials.gov ID
- NCT04369612
- Acronym / sponsor ID
- HBM-KTx / 134787
- Conditions
- Kidney Transplant Failure and Rejection
- Keywords
- capillary sample, finger-prick, home-based monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Apr 2020 (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.
Renal transplant recipients are followed as out patients at the transplant center for about 8 weeks after surgery. Between 1-2 weeks after surgery, 50 standard immunological patients will be randomized (1:1) to either follow standard of care (SOC) or having every second poli clinical visit without entering the hospital HBM; Home Based Monitoring). They are to take a capillary finger-prick blood sample themselves, send it to the laboratory for analysis and then they will get a telecom follow-up that day from their transplant physician. Outcome is no difference with regards to being able to follow the randomized follow-up procedure.
Detailed description
Renal transplant recipients are followed as out patients at the transplant center for about 8 weeks after surgery. Between 1-2 weeks after surgery, 50 standard immunological patients (i.e. first, kidney (only) transplants, no donors specific antibodies (DSA), panel reactive antibodies (PRA), ABO blood type compatible transplant) will be randomized (1:1) to either follow standard of care (SOC) or having every second poli clinical visit without entering the hospital HBM; Home Based Monitoring). They are to take a capillary finger-prick blood sample themselves and send it to the laboratory for analysis (creatinine, hemoglobin, tacrolimus and mycophenolate) and then they will get a telecom follow-up that day from their transplant physician. Outcome is no difference with regards to being able to follow the randomized follow-up procedure without having acute rejection episodes and no need for extra ou-patients visits for any reason. End of study is week 7-8 after transplantation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two Groups, randomized 1:1, to a) Standard of care and b) home-based monitoring. Followed between 1-2 to 7-8 weeks after transplantation
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Procedure: Standard follow-upStandard follow-up after kidney transplantation during the first 7-8 post-transplant weeks |
| Home-based monitoring | Experimental | Procedure: Home-based monitoringEvery second visit will be performed without patients actually visiting the hospital. They take a capillary blood sample themselves, send it to the lab and get a telecom follow-up by treating physician the same day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Kidney only transplant
- Immunosuppressive therapy With at least one of; tacrolimus, cyclosporine, everolimus, sirolimus, mycophenolate
- Standard immunological risk; no DSA, no PRA, not ABO-incompatible transplant
- Age above 18 years
- Followed at Oslo University Hospital-Rikshospitalet transplant center
Key exclusion criteria (2 listed)
- Pregnant or breast feeding female recipients
- Ongoing acute rejection episodes at time of inclusion
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 |
|---|---|---|
| Standard follow-upStandard post-transplant follow-up | Procedure or surgery | Standard of care |
| Home-based monitoringPatients take capillary blood sample by finger-prick and send to lab for analyses. Telecom follow-up that day by treating physician | Procedure or surgery | Home-based monitoring |
Primary outcome
Success rate
Time frame: 1-8 weeks post-transplant
Complete follow-up without acute rejection and no need for extra visit of any cause
1 secondary outcome
Extra visits to Control immunosuppressive drug levels
Time frame: 1-8 weeks post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No. Not allowed without specific ethical committee approval
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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.
Karsten Midtvedt, MD, PhD principal investigator
Oslo 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 Standard follow-up and Home-based monitoring in people with Kidney Transplant Failure and Rejection, run by Oslo University Hospital at 1 site in Norway.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Apr 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karsten Midtvedt, MD, PhD (0047-23071894, kmidtved@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 1-8 weeks post-transplant). 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 4 Apr 2024.