Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Success rate
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Success rate
Time Frame: 1-8 weeks post-transplant
Complete follow-up without acute rejection and no need for extra visit of any cause
Secondary Outcomes
- Extra visits to Control immunosuppressive drug levels(1-8 weeks post-transplant)
Investigators
Anders Åsberg
Head of Laboratory
Oslo University Hospital