Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples

Study Overview
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Brief Summary
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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
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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.

Official Title
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Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples

Conditions
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Kidney Transplant Failure and Rejection

Intervention / Treatment
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* Procedure: Standard follow-up
* Procedure: Home-based monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnant or breast feeding female recipients Ongoing acute rejection episodes at time of inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Standard follow-up after kidney transplantation during the first 7-8 post-transplant weeks | Procedure: Standard follow-up<br>* Standard post-transplant follow-up<br>|
| Experimental: Home-based monitoring<br>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. | Procedure: Home-based monitoring<br>* Patients take capillary blood sample by finger-prick and send to lab for analyses. Telecom follow-up that day by treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Complete follow-up without acute rejection and no need for extra visit of any cause | 1-8 weeks post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extra visits to Control immunosuppressive drug levels | Number of extra visits in order to monitoring appropriate drug Levels of immunosuppressive drugs | 1-8 weeks post-transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capillary sample, finger-prick, home-based monitoring